Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1644408

FEI Number

1000116912

Entity Name

ENCORE MEDICAL, L.P.

City/State/Country

AUSTIN, TX, US

Establishment Address

9800 METRIC BLVD., AUSTIN, TX 78758, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ENCORE MEDICAL, L.P. (Owner Number: 9002203)

Owner / Operator Contact Address

9800 METRIC BLVD., --, Austin, TX 78758, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K100741

PMA Number

N/A

All Registered Proprietary Names

EMPOWR Revision Symmetric Knee Cones EPIK - Unicondylar Knee EXPRT 5mm Femoral Augment, 400 Stem Extension EXPRT Revision Hip System R120 PC Hip Stem Lima Modular Revision Stem SR PIP Revelation Hip Stems with P2 Linear Hip Stems with P2 LSF FEMORAL NECK CUTTING GUIDE Rasp Foundation Total Shoulder System EMPOWR Blade Stem Hammer Foundation Ultra-Congruent TrueFix Manual Surgical Instrument Distractor Reverse Shoulder Prosthesis ENCORE RONGEURS Revelation microMAX Hemi Shoulder Prosthesis Awl CLP III Z-SERIES MODULAR HIP AltiVate Conversion Module Cemented Calcar Hip System Cobalt G-HV Bone Cement Cobalt HV Bone Cement Turon Revision Glenoid ORTHOPEDIC REAMER 3DKNEE PC Femoral Component FMP Acetabulatr Shells with 3DMatrix Foundation Porous Stem Size 8 Porous Patella ceramys femoral head system Turon Primary and Revision System AltiVate Reverse Short Stem Bipolar Hip Delta Femoral Heads & Offset Sleeve STAR Scandinavian Total Ankle Replacement Prosthesis TRUE/FLEX & TRUE/FIT INSTU FOUNDATION & VITALITY HIP & SHOULDE MULTIPLE (PROSTHESIS IMPACTOR) Foundation Plasma Metalbacked Patel Foundation Fracture Hip Stem EXPRT Revision Hip OPTIGUN AltiVate CS Edge Shoulder LSF FEMORAL TEMPLATE ENCORE TEMPLATE Linear Plasma Sprayed Hip Stem Foundation Distal Centralizer Discovery Elbow EMPOWR Acetabular® Liner Extension Foundation Augmentation Blocks ALTIVATE REVERSE GLENOID ANGLED REAMER AltiVate Reverse Wedge Glenoid Reamer Sleeve AltiVate Reverse Wedge Glenoid Reamer Boss Drill AltiVate Reverse Glenoid Peripheral Drill Guide AltiVate Reverse Wedge Glenoid Reamer Head AltiVate Reverse Glenoid Peripheral Drill/Screw Guide Replacement Thumbscrew AltiVate Reverse Glenoid Hood Rasp AltiVate Reverse Glenoid Hood Rasp Guide AltiVate Reverse® Glenoid AltiVate Reverse Glenoid Baseplate Rim Planer AltiVate Reverse Glenoid Cannulated Boss Drill AltiVate Reverse Glenoid Baseplate Inserter AltiVate Reverse Cannulated Glenoid Reamer Cobalt MV Bone Cement ENCORE IMPLANT SYST EMPOWR Stem Extender, 50mm DJO Surgical / Encore Medical Powered Instrument Foundation Metal Backed Patella ENCORE SCREWDRIVER UNIVERSAL JOINT SCREWDRIVER Forceps Reverse Shoulder Prosthesis (RSP) Foundation Lateral Pivot Insert Compression Hip/Supracondylar Screw Turon e+ Glenoid Exprt Knee System CLP Hip System Foundation PS Knee Surgical File/Planer/Rasp Foundation Glenoid Component RSP e+ Liner 3DKnee e+ Tibial Inserts AltiVate® Anatomic Shoulder AG e+ with Markers All Poly Tri Peg Sombrero Patella MTS Knee Encore Humeral Shoulder Stem 6.5 Cancellous Bone Screw Foundation Plasma Sprayed Femoral EMPOWR Porous Knee System Revelation Hip Stem, Sz 8 Metal/Metal Hip System Movation Knee System Cobalt G-MV Bone Cement LSF BROACH DJO Surgical Instrument Tray AltiVate® Anatomic Shoulder AG e+ with Markers (FW) 3DKNEE System ENCORE IMPLANT SYST AltiVate Reverse Small Shell System Keramos Ceramic-on-Ceramic Hip System FMP/Foundation Porous Hemispherical SR MCP CLP Hip Stem FEMORAL CUTTING CHISEL ENCORE CHISEL Foundation Porous Hip Stem EMPOWR Universal Tibial Baseplate CLP Offset Hip System Foundation Unipolar Chisel Foundation Forged Cemented Stem 9mm Foundation Porous Stem w/Metal Head EPIK - Unicondylar Knee EMPOWR Partial Knee FMP Porous Coated Flared Rim Shells FMP e+ Acetabular Liner FOUNDATION AND VITALITY HIP KNEE AND SHOULDER INSTRUMENT SYSTEMS , TRUE IX FMP Acetabular Shells with P2 Foundation Plasma Tibial Component Foundation Non-Porous Stem EMPOWR VVC Insert ARVIS® Shoulder DJO Surgical / Encore Medical Wrench EMPOWR Dual Mobility RSP Size 44 Heads RSP Size 44 Socket Shells Foundation HA Coated Stems Linear HA Coated Stems Revelation HA Coated Stems RSP Monoblock 8mm Spacer SHOULDER INSTRUMENTATION TRUE/FLEX , HIP FOUNDATION KNEE IX INSTRUMENAN & TRUE TaperFill Hip Stem EMPOWR Acetabular System Foundation Humeral Stem EMPOWR PS Knee System TrueFix Distal Femoral Intramedullary Rod System True/Fix Large Screw Depth Gauge X-alt Hip System FMP Shells Large CoCr Heads R120 Hip Stem HIP FOUNDATION KNEE ITALITY HIP INSTRUMENTS SYSTEM ,SHOULDER INSTRUMENT SYSTEMS Revelation Size 8 Hip Stem with P2 Foundation and 3DKnee All Poly Patella (standard poly and e+) Reverse Shoulder Prosthesis RSP to Foundation Humeral Stem Adapter RSP Monoblock Press Fit Indication FMP/Foundation Porous Acetabular Spiked Bone Tap Linear Hip Stem, sz 5 DJO Surgical / Encore Medical Surgical Punch Alfa II Hip Stem Modular Femoral Neck RSP Baseplate with P2 True/Fix Humeral Intramedullary Rod Empowr CR Knee Tibial Insert RSP Monoblock to Turon Conversion Adapter EMPOWR 3DKNEE ENCORE IMPACTORS Revelation Hip Stem RSP Monoblock RSP Size 44 Offset Insert RSP Size 44 Constrained Liner

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-05-22
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2024-05-22
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2009-05-07
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2016-09-28
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2016-12-20
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2016-12-20
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2016-12-20
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	1997-02-21
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	1997-02-21
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2010-08-18
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2010-08-18
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2010-08-18
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2010-08-18
MPK	Semi-Constrained Metal/Polymer Finger Joint Prosthesis	Unknown	Class f	N/A	2023-10-18
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2011-11-04
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2011-11-04
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2011-11-04
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2005-07-13
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2022-07-21
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2009-05-07
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2023-02-17
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2023-02-17
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2023-02-17
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2023-02-17
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-09-09
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2009-05-07
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2011-12-01
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	1997-02-21
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2009-05-07
HTX	Rongeur	Orthopedic	Class 1	888.4540	2005-07-13
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2011-11-04
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2011-11-04
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2011-11-04
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2011-11-04
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2009-05-07
HWJ	Awl	Orthopedic	Class 1	888.4540	2022-09-09
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2006-01-03
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2006-01-03
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2006-01-03
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2006-01-03
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2006-01-03
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2018-02-16
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2018-02-16
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3660	2018-02-16
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2009-03-26
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2017-02-17
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2017-02-17
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2009-03-25
HTO	Reamer	Orthopedic	Class 1	888.4540	2005-07-13
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2009-05-07
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2012-11-01
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2009-05-07
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2009-05-07
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2022-07-25
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2022-07-25
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-02-26
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2009-03-25
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2019-05-02
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-05-02
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2009-03-26
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2009-03-25
NTG	Prosthesis, Ankle, Uncemented, Non-Constrained	Unknown	Class 3	N/A	2021-08-05
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2001-07-13
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2009-05-07
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2023-04-10
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2023-04-10
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2009-03-26
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2017-03-03
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2017-03-03
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2017-03-03
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2021-08-13
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Orthopedic	Class 2	888.3660	2020-06-04
HWT	Template	Orthopedic	Class 1	888.4800	2006-01-03
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2012-02-02
JDG	Prosthesis, Hip, Femoral Component, Cemented, Metal	Orthopedic	Class 2	888.3360	2011-08-10
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2011-08-10
JDC	Prosthesis, Elbow, Constrained, Cemented	Orthopedic	Class 2	888.3150	2016-09-14
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2025-11-18
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-11-18
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2009-05-07
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-05-31
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-05-31
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2017-02-17
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2005-06-22
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2023-04-13
KTZ	Caliper	Orthopedic	Class 1	888.4150	2004-09-13
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	1997-02-21
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2009-05-07
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2006-01-03
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2022-09-19
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2009-05-07
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2009-05-07
LXT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	Orthopedic	Class 2	888.3030	2009-05-07
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3660	2013-05-16
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2013-05-16
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2015-01-21
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2015-01-21
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2009-05-07
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2009-05-07
GEO	File, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2023-07-11
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2009-05-07
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2015-01-21
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2015-01-21
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2011-11-04
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2011-11-04
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2011-11-04
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2022-07-21
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3660	2022-07-21
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2011-12-16
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2015-01-21
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2015-01-21
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2015-01-21
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-12-01
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2009-05-07
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2017-10-23
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2009-05-07
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2009-05-07
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2009-05-07
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2010-08-18
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2017-02-17
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2017-02-17
HTQ	Broach	Orthopedic	Class 1	888.4540	2005-07-13
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2010-09-08
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2023-06-26
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3660	2023-06-26
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2009-05-07
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2005-06-22
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2017-10-31
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2017-10-31
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2017-10-31
MRA	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented	Unknown	Class 3	N/A	2011-12-20
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2009-03-26
MPK	Semi-Constrained Metal/Polymer Finger Joint Prosthesis	Unknown	Class f	N/A	2023-10-18
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2012-02-02
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	2006-01-03
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2009-03-26
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2009-03-26
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-03-20
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2009-03-26
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2009-03-26
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2009-03-26
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2009-03-26
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2009-03-26
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2009-03-26
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2009-03-26
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2009-03-26
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2009-05-07
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2023-03-09
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2009-03-26
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2009-05-07
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2009-05-07
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2019-07-18
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2009-03-26
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-11-06
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2013-11-06
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2001-07-13
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2011-11-04
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2009-05-07
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2009-03-26
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-07-25
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2018-07-25
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-02-28
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-02-28
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-02-28
HXC	Wrench	Orthopedic	Class 1	888.4540	2012-04-24
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2021-02-10
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Orthopedic	Class 2	888.3660	2021-02-10
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2010-08-18
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2010-08-18
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2009-05-07
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2011-08-10
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2011-08-10
HWB	Extractor	Orthopedic	Class 1	888.4540	2001-07-13
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2013-07-05
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-07-05
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-07-05
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2019-06-25
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2019-06-25
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2009-05-07
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2016-05-19
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2016-05-19
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2009-05-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2009-05-07
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2024-06-10
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2009-03-26
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	1997-02-21
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	1997-02-21
HTT	Burr, Orthopedic	Orthopedic	Class 1	888.4540	2001-07-13
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2012-11-08
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2012-11-08
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2012-11-08
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2012-11-08
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2012-09-11
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2012-09-11
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2009-05-07
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2009-05-07
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2015-01-21
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2015-01-21
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2009-03-26
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2023-01-17
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2009-05-07
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2009-05-07
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-04-24
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	1997-02-21
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	1997-02-21
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2012-02-03
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2012-02-03
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2009-05-07
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2017-05-31
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2017-05-31
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2011-11-04
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2011-11-04
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2015-06-08
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2015-06-08
HWA	Impactor	Orthopedic	Class 1	888.4540	2005-07-13
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2009-05-07
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2010-08-18
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2010-08-18

Official Correspondent

Sherri Mellingen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ENCORE MEDICAL, L.P.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012439458	Mathys AG Bettlach	Bettlach Solothurn, CH
3036795922	Mathys Orthopaedie GmbH	Moersdorf Thuringia, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K102380	Wrightmedicaltechnologyinc	EVOLUTION MP TOTAL KNEE SYSTEM	2011-01-07
K122985	Aesculap Implant System, Inc.	COLUMBUS REVISION KNEE SYSTEM	2012-10-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2008	N/A	2	EPIK KNEE SYSTEM Angled Insert Impactor LM/RL; Catalog #801-03-051 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Z-0010-2008	N/A	1	EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Z-0041-2018	N/A	2	EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is posterior stabilized and is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.
Z-0042-2018	N/A	2	EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is posterior stabilized and is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1644408. Last updated year: 2026. Please use registration number 1644408 when referencing this establishment in official correspondence.