Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616671

FEI Number

3002854251

Entity Name

DEPUY (IRELAND)

City/State/Country

CO. CORK Munster, IE

Establishment Address

LOUGHBEG, RINGASKIDDY, CO. CORK Munster --, IE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

DePuy Synthes, Inc. (Owner Number: 1818910)

Owner / Operator Contact Address

700 Orthopaedic Drive, Warsaw, IN 46582, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K081163

PMA Number

N/A

All Registered Proprietary Names

various osteotome general instruments TELIGEN Bone Cement Sigma, Bannister (knee) SmartSet Bone Cement Delta (Shoulder) EVACUATOR VAPOR CEMENT MONOMER (MULTIPLE BRANDS) VACU-MIX PUMP Joint Recon Bone Hook Instrument Joint Reconstruction wire cutters Bone Cement Screwdrivers for Joint Recon Viper Prime Joint Recon Cutting Instrument M-Spec (Hip) Shoulder Replacement Device S-Rom (hip) Joint Recon Surgical instrument motors and accessories/attachments S-Rom, Articul/eze, Delta (hip) Instrument file for Joint Recon SmartSet Instrument Retractors TELIGEN Delta (shoulder) Global Unite (shoulder) Pinnacle, Marathon (hip) Sterilization change for: AMK (knee), AML (hip), Preservation (knee), Enduron (hip), Hylamer (knee), Duraloc (hip), Bantam (hip), Endurance (hip), ERS (elbow), Synatomic (knee), Global (shoulder), Self-Centering (hip), ACS (hip) Orthopaedic EXTRACTOR ATTUNE REVISION TIBIAL SLEEVE SEPARATOR - ATTUNE SLEEVE WEDGE ATTUNE REVISION TIBIAL SLEEVE SEPARATOR - BASE ATTACHMENT ATTUNE REVISION TIBIAL BASE TRIAL EXTRACTOR ATTUNE REVISION BOSS AND STEM ADAPTOR TRIAL EXTRACTOR PINNACLE Dual Mobility SmartSet S-Rom (hip) compression instrument for Joint Recon Viper Prime ARICULATED TENSION DEVICE SYNTHES TEN various cement dispensers TELIGEN WILLIAMS GAUGES Viper Prime Rasp for Joint Recon RASP MIXER CEMENT FOR CLINICAL USE (MULTIPLE BRANDS) various prosthesis drivers ATTUNE REVISION TIBIAL SLEEVE SEPARATOR - DRIVER TELIGEN ATTUNE Revision Tibial Base Rotating Platform Size 10 Cemented ATTUNE Revision CRS Rotating Platform Insert Size 6 18 mm ATTUNE REVISION RP INSERT TRIAL SIZE 6 18MM ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 53 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 18 mm ATTUNE REVISION RP INSERT TRIAL SIZE 7 18MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 24MM ATTUNE Revision CRS Rotating Platform Insert Size 3 8 mm ATTUNE Revision CRS Rotating Platform Insert Size 4 14 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 26 mm ATTUNE REVISION RP BASE TRIAL SIZE 4 ATTUNE REVISION RP INSERT TRIAL SIZE 4 12MM ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 45 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 16 mm ATTUNE REVISION RP INSERT TRIAL SIZE 7 16MM ATTUNE Revision CRS Rotating Platform Insert Size 4 10 mm ATTUNE Revision CRS Rotating Platform Insert Size 5 16 mm ATTUNE REVISION TIBIAL SLEEVE TRIAL 61MM ATTUNE REVISION RP INSERT TRIAL SIZE 4 8MM ATTUNE REVISION RP INSERT TRIAL SIZE 5 14MM ATTUNE Revision CRS Rotating Platform Insert Size 6 6 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 12 mm ATTUNE REVISION RP INSERT TRIAL SIZE 6 6MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 12MM ATTUNE Revision Tibial Base Rotating Platform Size 2 Cemented ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 61 mm ATTUNE Revision CRS Rotating Platform Insert Size 3 18 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 14 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 16MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 14MM ATTUNE Revision CRS Rotating Platform Insert Size 3 6 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 24 mm ATTUNE REVISION RP BASE TRIAL SIZE 3 ATTUNE REVISION RP INSERT TRIAL SIZE 4 10MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 24MM ATTUNE Revision CRS Rotating Platform Insert Size 3 12 mm ATTUNE Revision CRS Rotating Platform Insert Size 4 18 mm ATTUNE REVISION RP BASE TRIAL SIZE 6 ATTUNE REVISION RP INSERT TRIAL SIZE 4 16MM ATTUNE Revision CRS Rotating Platform Insert Size 5 26 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 10 mm ATTUNE REVISION RP INSERT TRIAL SIZE 5 26MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 10MM ATTUNE Revision CRS Rotating Platform Insert Size 5 22 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 8MM ATTUNE REVISION RP INSERT TRIAL SIZE 5 20MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 6MM ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 45 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 26 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 10 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 12MM ATTUNE REVISION RP INSERT TRIAL SIZE 6 26MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 10MM ATTUNE Revision CRS Rotating Platform Insert Size 4 22 mm ATTUNE REVISION RP BASE TRIAL SIZE 8 ATTUNE REVISION RP INSERT TRIAL SIZE 4 20MM ATTUNE Revision CRS Rotating Platform Insert Size 5 20 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 6MM ATTUNE REVISION RP INSERT TRIAL SIZE 5 18MM ATTUNE Revision CRS Rotating Platform Insert Size 4 26 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 10 mm ATTUNE REVISION RP BASE TRIAL SIZE 10 ATTUNE REVISION RP INSERT TRIAL SIZE 4 24MM ATTUNE REVISION RP INSERT TRIAL SIZE 6 10MM ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 29 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 22 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 6 mm ATTUNE REVISION RP INSERT TRIAL SIZE 6 22MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 6MM ATTUNE Revision CRS Rotating Platform Insert Size 4 12 mm ATTUNE Revision CRS Rotating Platform Insert Size 5 18 mm ATTUNE REVISION TIBIAL SLEEVE TRIAL 69MM ATTUNE REVISION RP INSERT TRIAL SIZE 5 16MM ATTUNE Revision Tibial Base Rotating Platform Size 9 Cemented ATTUNE Revision CRS Rotating Platform Insert Size 5 10 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 16 mm ATTUNE REVISION RP INSERT TRIAL SIZE 6 16MM ATTUNE Revision CRS Rotating Platform Insert Size 5 8 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 14 mm ATTUNE REVISION RP INSERT TRIAL SIZE 5 6MM ATTUNE REVISION RP INSERT TRIAL SIZE 6 14MM ATTUNE Revision Tibial Sleeve 29 mm Cemented ATTUNE Revision CRS Rotating Platform Insert Size 6 20 mm ATTUNE REVISION RP INSERT TRIAL SIZE 6 20MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 26MM ATTUNE Revision CRS Rotating Platform Insert Size 4 24 mm ATTUNE REVISION RP BASE TRIAL SIZE 9 ATTUNE REVISION RP INSERT TRIAL SIZE 4 22MM ATTUNE REVISION RP INSERT TRIAL SIZE 6 8MM ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 37 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 24 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 8 mm ATTUNE REVISION RP INSERT TRIAL SIZE 6 24MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 8MM ATTUNE Revision Tibial Base Rotating Platform Size 3 Cemented ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 69 mm ATTUNE Revision CRS Rotating Platform Insert Size 3 20 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 16 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 18MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 16MM ATTUNE Revision CRS Rotating Platform Insert Size 5 24 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 8 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 10MM ATTUNE REVISION RP INSERT TRIAL SIZE 5 24MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 8MM ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 37 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 8 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 14 mm ATTUNE REVISION RP INSERT TRIAL SIZE 7 14MM ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 69 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 22 mm ATTUNE REVISION RP BASE TRIAL SIZE 2 ATTUNE REVISION RP INSERT TRIAL SIZE 7 22MM ATTUNE Revision CRS Rotating Platform Insert Size 5 6 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 12 mm ATTUNE REVISION RP INSERT TRIAL SIZE 4 26MM ATTUNE REVISION RP INSERT TRIAL SIZE 6 12MM ATTUNE Revision Tibial Base Rotating Platform Size 6 Cemented ATTUNE Revision CRS Rotating Platform Insert Size 3 26 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 22 mm ATTUNE REVISION TIBIAL SLEEVE TRIAL 37MM ATTUNE REVISION RP INSERT TRIAL SIZE 3 24MM ATTUNE REVISION RP INSERT TRIAL SIZE 5 8MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 22MM ATTUNE Revision Tibial Base Rotating Platform Size 5 Cemented ATTUNE Revision CRS Rotating Platform Insert Size 3 24 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 20 mm ATTUNE REVISION TIBIAL SLEEVE TRIAL 29MM ATTUNE REVISION RP INSERT TRIAL SIZE 3 22MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 20MM ATTUNE Revision Tibial Base Rotating Platform Size 4 Cemented ATTUNE Revision Tibial Base Rotating Platform Size 7 Cemented ATTUNE Revision CRS Rotating Platform Insert Size 4 6 mm ATTUNE Revision CRS Rotating Platform Insert Size 5 12 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 24 mm ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 29 mm ATTUNE Revision CRS Rotating Platform Insert Size 3 22 mm ATTUNE REVISION TIBIAL SLEEVE TRIAL 45MM ATTUNE REVISION RP INSERT TRIAL SIZE 3 26MM ATTUNE Revision CRS Rotating Platform Insert Size 8 18 mm ATTUNE REVISION RP INSERT TRIAL SIZE 5 10MM ATTUNE REVISION RP STEM ADAPTOR TRIAL ATTUNE REVISION RP INSERT TRIAL SIZE 3 20MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 18MM ATTUNE Revision CRS Rotating Platform Insert Size 3 14 mm ATTUNE Revision CRS Rotating Platform Insert Size 4 20 mm ATTUNE REVISION RP BASE TRIAL SIZE 7 ATTUNE REVISION RP INSERT TRIAL SIZE 4 18MM ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 61 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 20 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 26 mm ATTUNE REVISION RP INSERT TRIAL SIZE 7 20MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 26MM ATTUNE Revision CRS Rotating Platform Insert Size 3 10 mm ATTUNE Revision CRS Rotating Platform Insert Size 4 16 mm ATTUNE REVISION RP BASE TRIAL SIZE 5 ATTUNE REVISION RP INSERT TRIAL SIZE 4 14MM ATTUNE Revision Tibial Base Rotating Platform Size 8 Cemented ATTUNE Revision CRS Rotating Platform Insert Size 4 8 mm ATTUNE Revision CRS Rotating Platform Insert Size 5 14 mm ATTUNE REVISION TIBIAL SLEEVE TRIAL 53MM ATTUNE REVISION RP INSERT TRIAL SIZE 4 6MM ATTUNE REVISION RP INSERT TRIAL SIZE 5 12MM ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 53 mm ATTUNE Revision CRS Rotating Platform Insert Size 3 16 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 6 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 12 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 14MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 12MM TRUMATCH Personalized Solutions ATTUNE® Revision Knee System LCS, New Jersey Total Knee Summit (hip) Delta (hip) Actis (hip) C-Stem (hip) PFC Sigma (knee), Darwin Attune (knee), AOX Darwin (knee), PFC Sigma Joing Recon Forceps, Wire Holding Joint Recon Hammers VARIOUS TYPES OF HAMMERS Caliper Instruments (Joint Recon) Viper Prime Bengal S-Rom (hip) Global (Shoulder) DePuy GLOBAL UNITE Shoulder System DELTA XTEND Reverse Shoulder System Delta (shoulder) S-Rom (hip) Impactor Instruments (Joint Recon) Bengal Expedium Viper Concorde Sigma (knee) LCS Complete Articul/eze (hip) saw Articul/eze (hip) SmartSet LPS (Limb Preservation System) Arthropor, S-Rom (hip) Sigma (knee), Bannister, Darwin Orthopaedic TAP Articul/eze (hip) S-Rom (hip), Articul/eze, M-Spec Pinnacle (hip) Smartset (bone cement) Joint Recon Passer Wire Global Shoulder DePuy GLOBAL UNITE Platform Shoulder System Delta (hip) various general plier instruments SmartSet wrenches for Joint Recon ATTUNE REVISION FEMORAL STRAIGHT STEM WRENCH CREATININE (LN 3L81-22, 3L81-32, 3L81-23, 3L81-33) Alinity c Creatinine Reagent Kit (LN 07P9920, 07P9930) Duraloc (hip) Reclaim (hip) Ultima (hip) Orthopaedic DRILL Charnley Joint Recon instrument -chisel, surgical, manual Expedium spine instrument Joint Recon Awl instruments templates guides tape, measuring, rulers and calipers for Joint Recon measuring PFC (hip) Delta (shoulder) Orthopaedic REAMER ATTUNE REVISION RP CONICAL REAMER Joint Recon Curettes TELIGEN Pinnacle, Gription (hip) Clamp for Joint Recon ASphere (hip), M-Spec Gouge instrumnts for Joint Recon Delta (hip) Corail AMT Hip Prosthesis instrument tray, instrument case Viper Prime ATTUNE REVISION SOLID RP INSERTS SIZE 5-6 CASE ATTUNE REVISION SOLID RP INSERTS SIZE 3-4 CASE ATTUNE REVISION TIBIAL BROACH CADDY ATTUNE REVISION SOLID RP INSERTS SIZE 7-8 CASE PINNACLE Dual Mobility Bone Cement various broach instruments ATTUNE REVISION TIBIAL BROACH 45MM ATTUNE REVISION TIBIAL BROACH 61MM ATTUNE REVISION TIBIAL BROACH 37MM ATTUNE REVISION TIBIAL BROACH 29MM ATTUNE REVISION TIBIAL BROACH 53MM ATTUNE REVISION TIBIAL BROACH 69MM S-Rom (hip) S-Rom (hip) Attune (knee) Acclaim Global Advantage Charnley Delta Xtend (shoulder) Joint Ortho Tamp Instrument Delta (shoulder) Smartset (bone cement)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2000-02-28
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2008-12-06
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2007-12-03
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2007-12-04
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2007-12-04
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2010-08-16
JDY	Evacuator, Vapor, Cement Monomer	Orthopedic	Class 1	888.4220	1978-03-27
KIK	Hook, Bone	General, Plastic Surgery	Class 1	878.4800	2015-09-16
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	1979-06-26
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2007-12-04
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2000-03-01
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	1979-06-26
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2014-09-23
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2014-09-23
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Orthopedic	Class 2	888.3660	2017-05-04
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2007-12-03
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-03-20
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2024-03-20
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2024-03-20
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-03-20
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2024-03-20
LRN	Wire, Surgical	Orthopedic	Class 2	888.3030	2024-03-20
LZY	Prosthesis, Hip, Hemi-, Femoral, Metal Ball	Orthopedic	Class 2	888.3360	2024-03-20
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2024-03-20
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2024-03-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-03-20
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2001-08-21
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2007-12-03
HTP	File	Orthopedic	Class 1	888.4540	2015-11-09
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2007-12-04
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2007-12-04
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1992-10-16
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2012-12-10
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2012-12-10
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2012-12-10
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2011-06-30
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2011-06-30
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2011-06-30
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2011-06-30
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2014-08-04
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2008-02-27
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2008-02-27
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2008-02-27
JDB	Prosthesis, Elbow, Semi-Constrained, Cemented	Orthopedic	Class 2	888.3160	2008-02-27
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2008-02-27
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2008-02-27
HWB	Extractor	Orthopedic	Class 1	888.4540	1979-06-26
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2007-12-04
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2007-12-04
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2007-12-03
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2007-12-03
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2007-12-03
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2015-11-09
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2004-03-26
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2000-02-28
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	1984-03-09
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2001-08-11
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Orthopedic	Class 2	888.3660	2022-02-09
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	1993-01-04
NJL	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing	Unknown	Class 3	N/A	2003-05-14
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2010-02-24
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2008-12-06
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2015-11-02
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2015-11-02
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2015-11-02
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2015-11-02
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2007-06-14
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2007-12-03
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2012-06-15
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2012-06-15
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2007-12-03
HYA	Forceps, Wire Holding	General, Plastic Surgery	Class 1	878.4800	1979-06-26
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	1981-03-02
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2016-08-09
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2016-08-09
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2016-08-09
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2016-08-09
KTZ	Caliper	Orthopedic	Class 1	888.4150	2015-11-06
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2007-12-03
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2014-09-23
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2014-09-23
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2014-09-23
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2019-12-06
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2019-12-06
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2009-04-15
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2009-04-15
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2009-04-15
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2007-12-03
HWA	Impactor	Orthopedic	Class 1	888.4540	1993-01-04
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2011-01-20
NJL	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing	Unknown	Class 3	N/A	2016-07-12
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2010-02-24
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2010-02-24
HSO	Saw	General, Plastic Surgery	Class 1	878.4800	1992-11-22
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2010-03-05
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2007-12-04
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2013-06-17
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-06-17
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2011-08-24
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2011-08-24
QBO	Instruments Designed For Press-Fit Osteochondral Implants	Orthopedic	Class 2	888.4505	2021-02-23
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2007-12-03
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2012-12-12
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2011-07-28
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2008-12-06
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2008-12-06
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2008-02-27
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2008-06-19
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	1977-12-22
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2020-05-29
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2018-01-17
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2018-01-17
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2018-01-17
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2011-09-28
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	1997-10-21
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2007-12-04
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2007-12-04
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2007-12-04
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2007-12-04
HXC	Wrench	Orthopedic	Class 1	888.4540	2015-11-10
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2022-01-06
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-01-06
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2022-01-06
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2016-03-01
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2022-01-06
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2015-06-30
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2011-01-11
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2007-12-03
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	1992-11-22
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	1977-12-22
HWJ	Awl	Orthopedic	Class 1	888.4540	2000-03-02
HWT	Template	Orthopedic	Class 1	888.4800	1992-11-22
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	1981-03-02
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2011-07-28
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2007-11-28
HTO	Reamer	Orthopedic	Class 1	888.4540	1993-01-04
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	1992-10-16
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2011-01-28
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2011-01-28
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2011-01-28
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2011-01-28
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2011-01-28
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	1978-03-27
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2011-02-11
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2011-02-11
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2011-02-11
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1977-12-22
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2009-06-02
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2018-09-25
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2018-09-25
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2018-09-25
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-09-25
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1992-12-02
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2007-12-04
HTQ	Broach	Orthopedic	Class 1	888.4540	1993-01-04
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2007-12-03
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2007-12-03
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2007-12-03
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2010-08-24
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2015-03-12
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2015-03-12
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1981-02-23
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2007-11-28
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2007-11-28
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2007-11-28
HXG	Tamp	Orthopedic	Class 1	888.4540	1993-01-04
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2020-11-12
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2020-11-12
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2020-11-12
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2020-11-12
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2011-08-17
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2011-08-17
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2011-08-17
MRA	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented	Unknown	Class 3	N/A	2012-01-04
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2008-06-19
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2008-06-19

Official Correspondent

No official correspondent registered.

US Agent Details

Patrick McCullagh Business: DePuy Synthes Email: pmccull1@its.jnj.com Phone: (267) 3005417

Related Public Records

Same Entity

DePuy Synthes, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009421413	GMED Healthcare BV (a Johnson & Johnson Company)	Leeds, GB
3004715683	Memphis Logistic Center	Memphis, TN, US
3015516266	Depuy Ireland UC	Co. Cork Munster, IE
1219655	DEPUY ORTHOPAEDICS, INC.	RAYNHAM, MA, US
3004464325	DEPUY ORTHOPAEDICS	BRIDGEWATER, MA, US

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-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

Similar Registrations

Registration Number	Establishment Name	Location
3007507973	ADLER INSTRUMENT COMPANY	Brooksville, FL, US
8010379	DEPUY INTL., LTD.	LEEDS, GB
3002862271	Wenzler Medizintechnik GmbH	Frittlingen Baden-Wurttemberg, DE
1926681	JEDMED Instrument Company	Saint Louis, MO, US
1424478	Merced Medical, Inc.	Scottsdale, AZ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616671. Last updated year: 2026. Please use registration number 9616671 when referencing this establishment in official correspondence.