Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004153240

FEI Number

3004153240

Entity Name

ConforMIS, Inc.

City/State/Country

Wilmington, MA, US

Establishment Address

600 Research Dr, Wilmington, MA 01887, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

restor3d, Inc. (Owner Number: 9058483)

Owner / Operator Contact Address

4001 NC-54, Suite 3160, Durham, NC 27709, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203421

PMA Number

N/A

All Registered Proprietary Names

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KNEE REPLACEMENT SYSTEM ITOTAL CR CRUCIATE RETAINING IJIG COMPONENTS ITOTAL CRUCIATE RETAINING TOTAL KNEE REPLACEMENT IUNI KNEE RESURFACING IUNI KNEE REPAIR IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM IUNI G2 UNICONDYLAR KNEE REPAIR IUNI KNEE REPAIR SYSTEM IUNI G2 UNICONDYLAR KNEE RESURFACING SYSTEM IUNI G2 IUNI G2 IJIG ANCILLARY INSTRUMENTS IUNI G2 UNICONDYLAR KNEE REPAIR SYSTEM IUNI IJIGS IUNI G2 IJIG INSTRUMENTS IUNI UNICONDYLAR KNEE REPLACEMENT IUNI KNEE REPLACEMENT IUNI KNEE REPLACEMENT SYSTEM IUNI UNICONDYLAR KNEE RESURFACING IUNI IJIG INSTRUMENTS IUNI G2 UNICONDYLAR KNEE REPLACEMENT IUNI PARTIAL KNEE REPLACEMENT SYSTEM IUNI G2 PARTIAL KNEE REPLACEMENT IUNI IJIG ANCILLARY INSTRUMENTS IUNI G2 KNEE REPAIR SYSTEM IUNI UNICONDYLAR KNEE REPAIR IUNI UNICONDYLAR KNEE REPAIR SYSTEM IUNI G2 IJIGS IUNI G2 KRS IUNI G2 PARTIAL KNEE REPLACEMENT SYSTEM IUNI G2 UNICONDYLAR KNEE RESURFACING IUNI G2 KNEE REPAIR IUNI G2 KNEE REPLACEMENT SYSTEM IUNI KRS IUNI G2 IJIG COMPONENTS IUNI PARTIAL KNEE 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CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM ITOTAL CR IJIG COMPONENTS ITOTAL CRUCIATE RETAINING ITOTAL CR KNEE REPLACEMENT ITOTAL CR TOTAL KNEE REPLACEMENT ITOTAL G2 CRUCIATE RETAINING IJIGS ITOTAL G2 TOTAL KNEE REPLACEMENT ITOTAL CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM ITOTAL CR KNEE REPLACEMENT SYSTEM ITOTAL CR CRUCIATE RETAINING IJIG COMPONENTS ITOTAL G2 CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM ITOTAL G2 CRUCIATE RETAINING IJIG ANCILLARY INSTRUMENTS ITOTAL CR TOTAL KNEE REPLACEMENT SYSTEM ITOTAL CR CRUCIATE RETAINING ITOTAL G2 KRS ITOTAL CRUCIATE RETAINING IJIGS ITOTAL CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM ITOTAL G2 CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM WITH IPOLY ITOTAL CR IJIG INSTRUMENTS ITOTAL CR CRUCIATE RETAINING KNEE REPLACEMENT ITOTAL CR KRS ITOTAL G2 ITOTAL KRS ITOTAL G2 CRUCIATE RETAINING IJIG COMPONENTS ITOTAL CRUCIATE RETAINING KNEE REPLACEMENT SYSTEM ITOTAL CRUCIATE RETAINING KNEE REPLACEMENT ITOTAL CR ITOTAL IJIG INSTRUMENTS ITOTAL KNEE REPLACEMENT ITOTAL IJIG ANCILLARY INSTRUMENTS ITOTAL CR CRUCIATE RETAINING IJIG INSTRUMENTS ITOTAL CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM WITH IPOLY ITOTAL G2 CRUCIATE RETAINING ITOTAL KNEE REPLACEMENT SYSTEM ITOTAL G2 KNEE REPLACEMENT SYSTEM ITOTAL CR CRUCIATE RETAINING KNEE REPLACEMENT SYSTEM ITOTAL CRUCIATE RETAINING IJIG INSTRUMENTS ITOTAL CR IJIG ANCILLARY INSTRUMENTS ITOTAL CR CRUCIATE RETAINING IJIGS ITOTAL ITOTAL CR CRUCIATE RETAINING IJIG ANCILLARY INSTRUMENTS ITOTAL G2 CRUCIATE RETAINING KRS ITOTAL CRUCIATE RETAINING KRS Radel Liner Impactors 28mm Cordera Hip System Cordera Trial Neck 127Degree 36.5mm Radel Liner Impactors 36mm Cordera Trial Neck 132deg 36.5mm Cordera Trial Neck 132degree 29mm Cordera Trial Neck 127degree 29mm Radel Liner Impactors 40mm Radel Liner Impactors 32mm Paragon Medical Surgical Instrument Delivery System IUNI G2 KRS IUNI G2 KNEE REPAIR IUNI KNEE RESURFACING SYSTEM IUNI G2 IJIG 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REPAIR SYSTEM IUNI IJIG COMPONENTS IUNI UNICONDYLAR KNEE REPAIR IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM IUNI IJIGS IUNI UNICONDYLAR KNEE REPLACEMENT IUNI KRS IUNI KNEE REPLACEMENT IUNI KNEE REPAIR iTotal Identity Posterior Stabilized Knee Replacement System iTotal CR Knee Replacement System iUni Unicondylar Knee Replacement System iTotal PS Knee Replacement System iDuo Bicompartmental Knee Repair System ITOTAL CR KNEE REPLACEMENT SYSTEM ITOTAL G2 CRUCIATE RETAINING IJIGS ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM ITOTAL TOTAL KNEE REPLACEMENT SYSTEM ITOTAL CRUCIATE RETAINING KRS iTotal: Tibial Component Extended Thickness Range ITOTAL CR CRUCIATE RETAINING IJIG COMPONENTS ITOTAL G2 CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM WITH IPOLY XE ITOTAL G2 CRUCIATE RETAINING ITOTAL CR CRUCIATE RETAINING IJIG INSTRUMENTS ITOTAL CR CRUCIATE RETAINING KRS ITOTAL G2 IJIGS ITOTAL G2 IJIG ANCILLARY INSTRUMENTS ITOTAL CRUCIATE RETAINING INSTRUMENT SET ITOTAL G2 CRUCIATE RETAINING IJIG INSTRUMENTS ITOTAL G2 CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM ITOTAL KNEE REPLACEMENT SYSTEM ITOTAL CR CRUCIATE RETAINING IJIGS ITOTAL CRUCIATE RETAINING IJIG COMPONENTS ITOTAL CR IJIG COMPONENTS ITOTAL CR TOTAL KNEE REPLACEMENT ITOTAL G2 CRUCIATE RETAINING KRS ITOTAL IJIG COMPONENTS ITOTAL CR IJIGS ITOTAL CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT ITOTAL KRS ITOTAL CR CRUCIATE RETAINING IJIG ANCILLARY INSTRUMENTS ITOTAL G2 CRUCIATE RETAINING IJIG COMPONENTS ITOTAL CR IJIG ANCILLARY INSTRUMENTS ITOTAL TOTAL KNEE REPLACEMENT ITOTAL CRUCIATE RETAINING KNEE REPLACEMENT ITOTAL CR INSTRUMENT SET ITOTAL CR KRS ITOTAL CRUCIATE RETAINING IJIG INSTRUMENTS ITOTAL CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM WITH IPOLY ITOTAL CRUCIATE RETAINING TOTAL KNEE REPLACEMENT ITOTAL G2 CRUCIATE RETAINING KNEE REPLACEMENT SYSTEM ITOTAL G2 CRUCIATE RETAINING KNEE REPLACEMENT ITOTAL KNEE REPLACEMENT ITOTAL CR IJIG INSTRUMENTS ITOTAL G2 KNEE REPLACEMENT SYSTEM ITOTAL CR TOTAL KNEE REPLACEMENT SYSTEM ITOTAL IJIG INSTRUMENTS ITOTAL IJIG ANCILLARY INSTRUMENTS ITOTAL G2 IJIG COMPONENTS ITOTAL CRUCIATE RETAINING ITOTAL ITOTAL CR CRUCIATE RETAINING KNEE REPLACEMENT SYSTEM ITOTAL CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM WITH IPOLY XE ITOTAL IJIGS ITOTAL CR KNEE REPLACEMENT ITOTAL CR CRUCIATE RETAINING ITOTAL G2 ITOTAL G2 CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM WITH IPOLY ITOTAL CR CRUCIATE RETAINING INSTRUMENT SET ITOTAL CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM CONFORMIS TOTAL KNEE REPAIR SYSTEM ITOTAL CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM ITOTAL G2 TOTAL KNEE REPLACEMENT ITOTAL G2 KNEE REPLACEMENT ITOTAL G2 CRUCIATE RETAINING IJIG ANCILLARY INSTRUMENTS ITOTAL CRUCIATE RETAINING TIBIAL TRAY ITOTAL CRUCIATE RETAINING IJIG ANCILLARY INSTRUMENTS ITOTAL G2 CRUCIATE RETAINING TOTAL KNEE REPLACEMENT ITOTAL CR CRUCIATE RETAINING KNEE REPLACEMENT ITOTAL CRUCIATE RETAINING KNEE REPLACEMENT SYSTEM ITOTAL CRUCIATE RETAINING IJIGS ITOTAL G2 IJIG INSTRUMENTS ITOTAL CR INSERT ITOTAL CR ITOTAL G2 KRS Identity Imprint CS Insert Identity Imprint CR insert trial 18mm Identity Imprint CS Insert trial iTotal Posterior Stabilized Knee Replacement System iTotal PS Knee Replacement System iTotal PS Knee Replacement System iTotal CR Knee Replacement System ACTERA (femoral stems sizes 0,1,10,11,12 and patient specific neck sizes 0-12) Femoral Trial Heads, reusable ACTERA Trial Necks ACTERA Broaches 0,1,10,11,12 ConforMIS iTotal® Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) ITOTAL KEEL PUNCH ITOTAL CR INSERT IMPACTOR TIP ITOTAL CR PATELLA REUSUABLE INSTRUMENT SET ITOTAL CR CRUCIATE RETAINING IMPACTOR HANDLE ITOTAL CR CRUCIATE RETAINING DRILL BIT WITH STOP ITOTAL CR CRUCIATE RETAINING KEEL PUNCH TIPS ITOTAL G2 CRUCIATE RETAINING TIBIAL DRILL GUIDE SLEEVE ITOTAL G2 DRILL BIT ITOTAL CRUCIATE RETAINING TIBIAL TRAY ITOTAL CR CRUCIATE RETAINING PATELLA SET ITOTAL CRUCIATE RETAINING FEMORAL DRILL BIT ITOTAL G2 STEINMAN PIN ITOTAL UNIVERSAL IMPACTOR HANDLE ITOTAL FEMORAL DRILL BIT ITOTAL G2 CRUCIATE RETAINING TRAY IMPACTOR TIP ITOTAL TACK PIN ITOTAL CALIPER IDUO PATELLA TRIAL ITOTAL CR CRUCIATE RETAINING PATELLA REUSUABLE INSTRUMENT TRAY ITOTAL CRUCIATE RETAINING TIBIAL DRILL BIT IDUO G2 PATELLAR OSTEOTOMY GUIDE IDUO G2 INSTRUMENT TRAY ITOTAL CRUCIATE RETAINING PATELLA INSTRUMENT TRAY ITOTAL G2 TOWNLEY CALIPER ITOTAL POLY IMPACTOR TIP ITOTAL PATELLA INSTRUMENT TRAY ITOTAL CRUCIATE RETAINING POLY INSERT IMPACTOR TIP ITOTAL G2 UNIVERSAL IMPACTOR HEAD ITOTAL G2 CRUCIATE RETAINING CORING TOOL ITOTAL G2 TRAY IMPACTOR TIP ITOTAL CRUCIATE RETAINING PATELLA SIZER ITOTAL CR PIN PULLER ITOTAL CR CRUCIATE RETAINING UNIVERSAL IMPACTOR HEAD ITOTAL G2 CRUCIATE RETAINING INSTRUMENT SET ITOTAL G2 CRUCIATE RETAINING POLY IMPACTOR TIP ITOTAL CR CRUCIATE RETAINING STEINMAN PIN ITOTAL CR STERILIZATION TRAY IDUO G2 PATELLA SET ITOTAL G2 CRUCIATE RETAINING CALIPER ITOTAL CR CRUCIATE RETAINING INSTRUMENT TRAY IDUO G2 TOWNLEY CALIPER ITOTAL G2 CRUCIATE RETAINING UNIVERSAL IMPACTOR HANDLE ITOTAL G2 PIN PULLER ITOTAL CR TIBIAL DRILL BIT ITOTAL CRUCIATE RETAINING DRILL BIT IDUO G2 PATELLA INSTRUMENT SET ITOTAL CR PATELLAR OSTEOTOMY GUIDE ITOTAL CR CRUCIATE RETAINING TIBIAL TRAY IMPACTOR TIP ITOTAL CRUCIATE RETAINING STEINMAN PIN IDUO INSTRUMENT SET ITOTAL G2 CRUCIATE RETAINING TIBIAL DRILL BIT IDUO DRILL BIT WITH STOP ITOTAL CRUCIATE RETAINING DRILL SLEEVE IDUO G2 PATELLA DRILL BIT WITH STOP ITOTAL CRUCIATE RETAINING UNIVERSAL IMPACTOR HEAD ITOTAL G2 CRUCIATE RETAINING TIBIAL STEM DRILL BIT IDUO PATELLA SIZER ITOTAL CR STEINMAN PIN ITOTAL G2 CRUCIATE RETAINING PATELLA TRIAL ITOTAL G2 CRUCIATE RETAINING PATELLA INSTRUMENT SET IDUO PATELLA DRILL BIT ITOTAL DRILL SLEEVE ITOTAL G2 CRUCIATE RETAINING STEM DRILL BIT ITOTAL CR CRUCIATE RETAINING PATELLA INSTRUMENT TRAY ITOTAL CR TIBIAL DRILL GUIDE SLEEVE ITOTAL CR TRAY IMPACTOR TIP ITOTAL G2 KEEL PUNCH TIPS ITOTAL G2 PATELLA CLAMP ITOTAL G2 CRUCIATE RETAINING PATELLA DRILL BIT ITOTAL G2 TIBIAL INSERT IMPACTOR TIP ITOTAL G2 CRUCIATE RETAINING PATELLA DRILL BIT WITH STOP ITOTAL CRUCIATE RETAINING POLY IMPACTOR TIP IDUO PATELLA INSTRUMENT TRAY ITOTAL CR CRUCIATE RETAINING STERILIZATION TRAY ITOTAL CRUCIATE RETAINING REUSABLE INSTRUMENT TRAY ITOTAL CRUCIATE RETAINING TIBIAL STEM DRILL BIT ITOTAL CR CRUCIATE RETAINING PATELLA REUSUABLE INSTRUMENT SET ITOTAL CRUCIATE RETAINING KEEL PUNCH TIPS ITOTAL CRUCIATE RETAINING PATELLA DRILL BIT ITOTAL STEINMAN PIN ITOTAL CRUCIATE RETAINING CORING TOOL ITOTAL G2 CRUCIATE RETAINING TOWNLEY CALIPER ITOTAL CR CRUCIATE RETAINING GUIDANCE PLUG ITOTAL G2 REUSABLE INSTRUMENT TRAY ITOTAL G2 CALIPER ITOTAL CR IMPACTOR HANDLE ITOTAL G2 REUSABLE INSTRUMENT SET ITOTAL G2 CRUCIATE RETAINING PATELLA SIZER ITOTAL G2 CRUCIATE RETAINING PIN PULLER ITOTAL PATELLA REUSUABLE INSTRUMENT SET ITOTAL G2 IMPACTOR HANDLE IDUO PATELLA CLAMP ITOTAL PATELLA SIZER ITOTAL PATELLA CLAMP ITOTAL G2 KEEL PUNCH ITOTAL CRUCIATE RETAINING PATELLA SET IDUO STERILIZATION TRAY IDUO G2 PATELLA CLAMP ITOTAL REUSABLE INSTRUMENT TRAY IDUO REUSABLE INSTRUMENT TRAY ITOTAL CR CRUCIATE RETAINING DRILL SLEEVE ITOTAL CR CRUCIATE RETAINING DRILL GUIDE SLEEVE ITOTAL CR CRUCIATE RETAINING TIBIAL DRILL GUIDE SLEEVE IDUO REUSABLE INSTRUMENT SET ITOTAL CR CRUCIATE RETAINING PATELLA INSTRUMENT SET ITOTAL CR CRUCIATE RETAINING POLY INSERT IMPACTOR TIP ITOTAL CR CRUCIATE RETAINING POLY IMPACTOR TIP ITOTAL G2 INSTRUMENT TRAY ITOTAL CRUCIATE RETAINING TIBIAL INSERT IMPACTOR TIP ITOTAL G2 GUIDANCE PLUG ITOTAL CR CRUCIATE RETAINING INSTRUMENT SET ITOTAL G2 CRUCIATE RETAINING STEINMAN PIN ITOTAL TIBIAL INSERT IMPACTOR TIP ITOTAL STERILIZATION TRAY ITOTAL CR KEEL PUNCH TIPS IDUO G2 DRILL BIT WITH STOP ITOTAL G2 TIBIAL DRILL BIT ITOTAL ALIGNMENT ROD ITOTAL PATELLAR OSTEOTOMY GUIDE IDUO PATELLA REUSUABLE INSTRUMENT TRAY ITOTAL G2 PATELLA REUSUABLE INSTRUMENT SET ITOTAL G2 CRUCIATE RETAINING PATELLA CLAMP ITOTAL INSTRUMENT SET IDUO G2 DRILL BIT IDUO TOWNLEY CALIPER IDUO G2 PATELLA REUSUABLE INSTRUMENT TRAY ITOTAL G2 CRUCIATE RETAINING PATELLAR OSTEOTOMY GUIDE ITOTAL G2 CRUCIATE RETAINING PATELLA REUSUABLE INSTRUMENT TRAY IDUO PATELLA INSTRUMENT SET ITOTAL CRUCIATE RETAINING PATELLA TRIAL ITOTAL G2 PATELLAR OSTEOTOMY GUIDE ITOTAL IMPACTOR HANDLE IDUO G2 PATELLA TRAY ITOTAL CRUCIATE RETAINING TIBIAL TRAY IMPACTOR TIP ITOTAL G2 CRUCIATE RETAINING UNIVERSAL IMPACTOR HEAD ITOTAL CRUCIATE RETAINING PATELLA REUSUABLE INSTRUMENT TRAY ITOTAL CR CRUCIATE RETAINING PATELLA CLAMP IDUO G2 PATELLA REUSUABLE INSTRUMENT SET ITOTAL G2 TACK PIN ITOTAL CRUCIATE RETAINING TACK PIN ITOTAL UNIVERSAL IMPACTOR HEAD ITOTAL PATELLA INSTRUMENT SET IDUO PATELLA SET IDUO G2 REUSABLE INSTRUMENT SET IDUO G2 PATELLA DRILL BIT ITOTAL CR CRUCIATE RETAINING KEEL PUNCH ITOTAL PIN PULLER IDUO OSTEOTOMY GUIDE ITOTAL G2 POLY INSERT IMPACTOR TIP ITOTAL PATELLA DRILL BIT ITOTAL POLY INSERT IMPACTOR TIP ITOTAL CR CRUCIATE RETAINING OSTEOTOMY GUIDE ITOTAL G2 CRUCIATE RETAINING STERILIZATION TRAY ITOTAL CR PATELLA TRAY ITOTAL TRAY IMPACTOR TIP ITOTAL G2 OSTEOTOMY GUIDE ITOTAL G2 STERILIZATION TRAY ITOTAL CRUCIATE RETAINING INSERT IMPACTOR TIP ITOTAL INSTRUMENT TRAY ITOTAL G2 INSTRUMENT SET ITOTAL CR GUIDANCE PLUG IDUO G2 CALIPER ITOTAL REUSABLE INSTRUMENT SET ITOTAL CR OSTEOTOMY GUIDE ITOTAL CRUCIATE RETAINING CALIPER ITOTAL TIBIAL DRILL GUIDE SLEEVE ITOTAL CR DRILL BIT IDUO G2 REUSABLE INSTRUMENT TRAY ITOTAL G2 CRUCIATE RETAINING FEMORAL DRILL BIT ITOTAL CR TOWNLEY CALIPER ITOTAL G2 PATELLA DRILL BIT ITOTAL CR PATELLA CLAMP ITOTAL G2 PATELLA SET ITOTAL CR POLY IMPACTOR TIP ITOTAL CR REUSABLE INSTRUMENT TRAY ITOTAL CR PATELLA INSTRUMENT TRAY ITOTAL G2 CRUCIATE RETAINING PATELLA REUSUABLE INSTRUMENT SET ITOTAL CRUCIATE RETAINING GUIDANCE PLUG ITOTAL CRUCIATE RETAINING PATELLA DRILL BIT WITH STOP ITOTAL KEEL PUNCH TIPS IDUO CALIPER ITOTAL CRUCIATE RETAINING INSTRUMENT SET ITOTAL CRUCIATE RETAINING TIBIAL DRILL GUIDE SLEEVE ITOTAL G2 CRUCIATE RETAINING PATELLA TRAY ITOTAL G2 UNIVERSAL IMPACTOR HANDLE ITOTAL CR CRUCIATE RETAINING PATELLAR OSTEOTOMY GUIDE ITOTAL G2 CRUCIATE RETAINING INSTRUMENT TRAY ITOTAL CR CRUCIATE RETAINING TRAY IMPACTOR TIP ITOTAL CR CRUCIATE RETAINING ALIGNMENT ROD ITOTAL OSTEOTOMY GUIDE IDUO PATELLAR OSTEOTOMY GUIDE ITOTAL G2 CRUCIATE RETAINING TACK PIN ITOTAL CR CRUCIATE RETAINING PATELLA DRILL BIT ITOTAL DRILL GUIDE SLEEVE ITOTAL G2 PATELLA TRIAL ITOTAL PATELLA TRIAL ITOTAL CR INSTRUMENT TRAY ITOTAL CR TACK PIN ITOTAL GUIDANCE PLUG ITOTAL G2 TIBIAL DRILL GUIDE SLEEVE ITOTAL CR CRUCIATE RETAINING STEM DRILL BIT ITOTAL G2 CRUCIATE RETAINING OSTEOTOMY GUIDE ITOTAL G2 INSERT IMPACTOR TIP ITOTAL CR PATELLA DRILL BIT ITOTAL G2 CRUCIATE RETAINING IMPACTOR HANDLE ITOTAL G2 CRUCIATE RETAINING GUIDANCE PLUG ITOTAL CR CRUCIATE RETAINING REUSABLE INSTRUMENT SET ITOTAL G2 FEMORAL DRILL BIT ITOTAL TIBIAL STEM DRILL BIT IDUO G2 INSTRUMENT SET ITOTAL G2 CRUCIATE RETAINING DRILL BIT WITH STOP ITOTAL CRUCIATE RETAINING STEM DRILL BIT ITOTAL CR CRUCIATE RETAINING PATELLA TRAY ITOTAL G2 PATELLA INSTRUMENT TRAY ITOTAL G2 CRUCIATE RETAINING DRILL SLEEVE ITOTAL CR CRUCIATE RETAINING CORING TOOL ITOTAL CR TIBIAL INSERT IMPACTOR TIP ITOTAL TOWNLEY CALIPER IDUO PATELLA TRAY ITOTAL G2 CRUCIATE RETAINING INSERT IMPACTOR TIP ITOTAL CR CRUCIATE RETAINING REUSABLE INSTRUMENT TRAY ITOTAL CR UNIVERSAL IMPACTOR HEAD ITOTAL CR CRUCIATE RETAINING PATELLA DRILL BIT WITH STOP ITOTAL CR CRUCIATE RETAINING TIBIAL STEM DRILL BIT ITOTAL CR DRILL SLEEVE ITOTAL G2 CRUCIATE RETAINING KEEL PUNCH TIPS ITOTAL CR CRUCIATE RETAINING TIBIAL INSERT IMPACTOR TIP ITOTAL CR CRUCIATE RETAINING DRILL BIT ITOTAL PATELLA REUSUABLE INSTRUMENT TRAY ITOTAL CRUCIATE RETAINING IMPACTOR HANDLE ITOTAL CR REUSABLE INSTRUMENT SET ITOTAL CR CRUCIATE RETAINING TACK PIN ITOTAL G2 PATELLA SIZER ITOTAL CR DRILL BIT WITH STOP ITOTAL CR CRUCIATE RETAINING PATELLA TRIAL ITOTAL STEM DRILL BIT ITOTAL G2 PATELLA INSTRUMENT SET IDUO G2 PATELLA INSTRUMENT TRAY IDUO INSTRUMENT TRAY ITOTAL CR KEEL PUNCH ITOTAL CRUCIATE RETAINING PIN PULLER ITOTAL TIBIAL DRILL BIT ITOTAL G2 CRUCIATE RETAINING POLY INSERT IMPACTOR TIP ITOTAL G2 CRUCIATE RETAINING TIBIAL INSERT IMPACTOR TIP ITOTAL CR PATELLA REUSUABLE INSTRUMENT TRAY ITOTAL CR CRUCIATE RETAINING FEMORAL DRILL BIT ITOTAL CRUCIATE RETAINING PATELLA CLAMP ITOTAL G2 PATELLA REUSUABLE INSTRUMENT TRAY ITOTAL CR TIBIAL TRAY IMPACTOR TIP ITOTAL CRUCIATE RETAINING KEEL PUNCH ITOTAL G2 TIBIAL TRAY IMPACTOR TIP ITOTAL G2 DRILL BIT WITH STOP IDUO PATELLA DRILL BIT WITH STOP ITOTAL G2 DRILL SLEEVE ITOTAL DRILL BIT WITH STOP ITOTAL CR CRUCIATE RETAINING TIBIAL DRILL BIT IDUO G2 OSTEOTOMY GUIDE ITOTAL CR CRUCIATE RETAINING PATELLA SIZER ITOTAL G2 CRUCIATE RETAINING KEEL PUNCH ITOTAL G2 CRUCIATE RETAINING DRILL BIT ITOTAL CR DRILL GUIDE SLEEVE ITOTAL PATELLA TRAY ITOTAL G2 ALIGNMENT ROD ITOTAL G2 CRUCIATE RETAINING DRILL GUIDE SLEEVE ITOTAL CR ALIGNMENT ROD ITOTAL CR PATELLA DRILL BIT WITH STOP ITOTAL CR PATELLA SIZER IDUO G2 PATELLA SIZER ITOTAL CR CRUCIATE RETAINING UNIVERSAL IMPACTOR HANDLE ITOTAL CRUCIATE RETAINING OSTEOTOMY GUIDE ITOTAL PATELLA SET ITOTAL G2 CRUCIATE RETAINING PATELLA SET ITOTAL CR PATELLA INSTRUMENT SET ITOTAL CRUCIATE RETAINING STERILIZATION TRAY ITOTAL CRUCIATE RETAINING INSTRUMENT TRAY IDUO PATELLA REUSUABLE INSTRUMENT SET ITOTAL CR CORING TOOL ITOTAL PATELLA DRILL BIT WITH STOP ITOTAL CRUCIATE RETAINING PATELLA REUSUABLE INSTRUMENT SET ITOTAL CR UNIVERSAL IMPACTOR HANDLE ITOTAL CR CRUCIATE RETAINING TOWNLEY CALIPER ITOTAL G2 CORING TOOL ITOTAL INSERT IMPACTOR TIP ITOTAL G2 CRUCIATE RETAINING REUSABLE INSTRUMENT SET ITOTAL CRUCIATE RETAINING TOWNLEY CALIPER ITOTAL CR TIBIAL STEM DRILL BIT ITOTAL G2 TIBIAL STEM DRILL BIT ITOTAL CR CRUCIATE RETAINING INSERT IMPACTOR TIP ITOTAL CRUCIATE RETAINING ALIGNMENT ROD IDUO G2 PATELLA TRIAL ITOTAL CRUCIATE RETAINING PATELLAR OSTEOTOMY GUIDE ITOTAL CR PATELLA SET ITOTAL CR CALIPER ITOTAL CR CRUCIATE RETAINING CALIPER ITOTAL DRILL BIT ITOTAL G2 CRUCIATE RETAINING REUSABLE INSTRUMENT TRAY ITOTAL G2 CRUCIATE RETAINING TIBIAL TRAY IMPACTOR TIP ITOTAL G2 POLY IMPACTOR TIP ITOTAL CRUCIATE RETAINING PATELLA TRAY ITOTAL G2 PATELLA DRILL BIT WITH STOP ITOTAL CR INSERT ITOTAL G2 DRILL GUIDE SLEEVE ITOTAL TIBIAL TRAY IMPACTOR TIP ITOTAL CR STEM DRILL BIT ITOTAL CRUCIATE RETAINING DRILL GUIDE SLEEVE ITOTAL CR POLY INSERT IMPACTOR TIP ITOTAL CRUCIATE RETAINING DRILL BIT WITH STOP ITOTAL CR PATELLA TRIAL ITOTAL CR INSTRUMENT SET ITOTAL CR FEMORAL DRILL BIT ITOTAL CRUCIATE RETAINING PATELLA INSTRUMENT SET ITOTAL CR CRUCIATE RETAINING PIN PULLER ITOTAL G2 CRUCIATE RETAINING ALIGNMENT ROD ITOTAL G2 PATELLA TRAY ITOTAL CRUCIATE RETAINING UNIVERSAL IMPACTOR HANDLE ITOTAL G2 STEM DRILL BIT ITOTAL CRUCIATE RETAINING REUSABLE INSTRUMENT SET ITOTAL CORING TOOL ITOTAL G2 CRUCIATE RETAINING PATELLA INSTRUMENT TRAY IDUO DRILL BIT ITOTAL CRUCIATE RETAINING TRAY IMPACTOR TIP IDUO G2 STERILIZATION TRAY Trifecta Universal Reusable Instrument Lid 1080-125 OrthoGroup Cup Impactor Femoral Stem Extractor Handle Extension iTotal/ Identity/ Imprint Femoral Plug Trifecta Identity Reusable Instrument Tray with Insert 1080-127 Cordera Acetabular Reusable Instrument Tray insert and base Blunt Steinman Pins Offset Cup Impactor Enztec T-handle Quick Connect Femoral Stem Extractor Straight Adaptor Threaded Femoral Stem Extractor Loop Adaptor iTotal iPoly Impactor Tip iTotal Poly Impactor Femoral Stem Extractor Handle Cordera Femoral Reusable Instrument Tray insert and base iTotal Patella Implant sizers Offset Reamer Driver Enztec Identity/ Imprint Patellar Osteotomy Guide Identity Imprint Porous Patella Clamp Hip Broach Handle Neutral DRILL, DIA 5.5MM X 79MM, W/STOP Flex drills: 3.5mm x 35mm; 3.5mm x 50mm; 5.5mm x 25mm Femoral Head Remover Calcar Planer Adaptor Short Calcar Planer Calcar Planer Adaptor Acetabular reamer handle and sleeve Drill Guide, double ended iTotal Impactor Head iTotal CORING TOOL W/ HUDSON ADAPTOR iDuo Patella Trials Tapered Femoral Reamer PATELLA, DRILL BIT, 5.5MM W/ HUDSON ADAPTOR Actera Trial Necks single Use iTotal STEM DRILL 10MM W/ HUDSON ADAPTOR Modular Box Osteotome 8MM X 20MM Femoral canal finder Acetabular Cup Impactor iDuo Patella Implant Sizers Screw driver- rigid and flexible Broach Handles Gen 2 Neutral, offset right, offset left Threaded Cup Impactor Long Identity Imprint Porous half keel punches: small, medium, large Drill Guide Identity Imprint Porous Steering Femoral Inserter 3.5MM Hex U-Joint Driver iTotal Patella trials Bone Rasp Hip Broach Handle Offset left Femoral Stem Impactor, offset Femoral Rasp iTotal Keel Punch Tips, PS or CR, Serrated or Non-serrated iTotal PS Tibial Tray Impactor tip Pin Puller Hip Broach Handle Offset right Threaded Headed Pin screw driver handle Identity Imprint Porous Patella Drill bits iTotal STEM DRILL 12MM W/ HUDSON ADAPTOR Screw Holding forceps Femoral Head Impactor ANGEL WING RESECTION GUIDE Ratcheting Quick-Connect Handle ITOTAL FEMORAL DRILL BIT 8MM W/ HUDSON ADAPTOR ITOTAL STEM DRILL 14MM W/ HUDSON ADAPTOR Universal Trail Heads: 28MM, 32MM, 38MM, 40MM iTotal Alignment Rod Taper 150mm Depth gauge PATELLA CLAMP ASSEMBLY ITOTAL STEINMAN PIN 3.18MM iTotal Identity Impactor Handle Femoral Stem Impactor Identity Imprint Porous CR Femoral implants Identity Imprint Porous CR Round Patella Implants Identity Imprint Porous CR Ancillary Reusable instrument tray with lid Identity Imprint Porous CR iJigs Identity Imprint Porous CR Oval Patella Implants Identity Imprint Porous CR Tibial Implants Identity Imprint Porous CR KRS Triathlon AS-1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2010-12-02
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2021-05-20
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2021-05-20
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2021-05-20
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-12-26
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2010-12-02
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2016-03-30
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2016-03-30
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2016-03-30
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-12-26
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2014-12-26
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2014-12-26
NPJ	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2010-12-02
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2016-08-22
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2016-08-22
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2016-08-22
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2012-11-15
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2012-11-15
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2012-11-15
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-12-29
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2025-12-29
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-12-29
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2025-12-29
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2014-04-25
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2014-04-25
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-04-25
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2020-09-25
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2020-09-25
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2020-09-25
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2020-09-25
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2017-03-21
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2014-10-16
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2014-10-16
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2017-12-29
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2017-12-29
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2017-12-29
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2017-12-29
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2017-12-29
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2011-11-29
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2011-11-29
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2021-05-21
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2021-05-21
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2021-05-21
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2012-11-15
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2012-11-15
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2019-11-22
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2019-11-22
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2019-11-22
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2019-11-22
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2019-11-22
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2019-11-22
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2019-11-22
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2019-11-22
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2019-09-04
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2019-09-04
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2019-09-04
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2007-03-06
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2020-06-18
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2020-06-18
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2020-06-18
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2020-12-02
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2020-12-02
NPJ	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2020-12-02
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2020-12-02
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2020-12-02
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2014-09-17
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2014-09-17
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-09-17
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2023-05-01
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2023-05-01
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2023-05-01
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-09-16
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2014-09-16
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2014-09-16
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2016-03-23
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2016-03-23
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2016-03-23
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2023-06-13
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2023-06-13
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2016-07-07
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2016-07-07
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2016-07-07
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2007-08-24
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2023-08-01
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2023-08-01
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2023-08-01
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2023-08-01
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2021-04-21
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2021-04-21

Official Correspondent

Brianna Prindle

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

restor3d, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

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Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033769	Howmedica Osteonics Corp.	EIUS UNICOMPARTMENTAL KNEE SYSTEM	2004-02-13
K771511	3M Company	TOTAL KNEE PROSTHESIS-NONCONSTRAINED	1977-11-30
K901338	Kirschner Medical Corp.	KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM	1990-05-22
K030577	Stelkast Company	PROVEN MODULAR TIBIAL TRAY	2003-03-25
K153310	Total Joint Orthopedics, Inc.	Klassic Knee System	2015-12-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2019	Smith & Nephew, Inc.	2	Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019	Smith & Nephew, Inc.	2	JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149
Z-0003-2017	Zimmer Biomet, Inc.	2	Vanguard 360 Revision Knee System Knee prostheses
Z-0003-2019	Smith & Nephew, Inc.	2	JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326
Z-0013-06	Plus Orthopedics USA	2	TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004153240. Last updated year: 2026. Please use registration number 3004153240 when referencing this establishment in official correspondence.