Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006356043

FEI Number

3006356043

Entity Name

JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD.

City/State/Country

SUZHOU Jiangsu, CN

Establishment Address

NO.299, CHANGYANG STREET, SUZHOU INDUSTRIAL PARK, SUZHOU Jiangsu 215126, CN

Establishment Type(s)

Manufacture Medical Device

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

K160907

PMA Number

N/A

All Registered Proprietary Names

Sigma, Bannister (knee) Microlock (knee), PFC EMPHASYS Femoral Stems C-Stem (hip), Articul/eze Summit (hip) Duraloc (hip) Global Advantage (shoulder) Articul/eze (hip) Sigma (knee) MERLIN Global Unite Platform Shoulder System Short Stem Duraloc (hip), Solution, Sector, Profile, Bantam viper monarch expedium EXPEDIUM Apex (hip) templates guides Attune (Knee) Enduron, Hylamer Change in pkg of UHMWPE components for Multicup, Ogee, cement restrictor, AMK poly tib & patella & tib insert, Synatomic PFC Knee 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 ATTUNE Medial Stabilized Fixed Bearing Insert Summit Hip System S-Rom (hip) J-FX BiPOLAR HEAD Articul/eze (hip) Cathcart (hip), Articul/eze Darwin (knee), TC3, PFC Sigma AML ( hip) Focus (hip), Articul/eze Attune Global Advantage Shoulder Actis (hip) Darwin (knee), PFC Sigma 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 Duraloc (hip), Solution Attune (knee) DELTA XTEND Reverse Shoulder System broach, wire cutter, prosthesis driver, extractor, file, femoral neck punch, reamer, screwdriver, tamp wrench, etc. Attune Pinnacle Viper Prime ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 5 ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 4 ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 8 ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 3 ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 7 ATTUNE REVISION FEMORAL IM ADAPTOR ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 6 PINNACLE Dual Mobility TELIGEN C-Stem AMT (hip), Articul/eze Sigma (knee), Bannister, Darwin PFC Sigma (knee) PFC Sigma (knee), Darwin Elite (hip) Duraloc (hip), Marathon C-stem (hip)

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	2007-12-03
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2008-06-27
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2021-08-10
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2021-08-10
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2021-08-10
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2021-08-10
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2009-07-17
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2009-07-17
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2009-07-17
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2007-12-06
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2012-11-05
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2012-11-05
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2008-02-27
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2008-02-27
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
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2011-01-20
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2018-12-03
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2018-12-03
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2018-12-03
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2018-12-03
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2018-12-03
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2020-11-25
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2020-11-25
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2020-11-25
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2007-06-14
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2016-09-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2016-09-21
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2016-09-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-09-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-09-21
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2016-09-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-01-08
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-01-08
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-01-08
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-01-08
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-01-08
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2019-01-08
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2010-02-24
HWT	Template	Orthopedic	Class 1	888.4800	1992-11-22
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2012-03-22
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2012-03-22
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2007-12-06
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Orthopedic	Class 2	888.3170	2007-12-06
JDB	Prosthesis, Elbow, Semi-Constrained, Cemented	Orthopedic	Class 2	888.3160	2007-12-06
LZN	Cement Obturator	General, Plastic Surgery	Class 2	878.3300	2007-12-06
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2007-12-06
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2007-12-03
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
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1992-12-02
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2021-08-26
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2021-08-26
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2021-08-26
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2022-08-17
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-08-17
LZY	Prosthesis, Hip, Hemi-, Femoral, Metal Ball	Orthopedic	Class 2	888.3360	2018-07-11
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2018-07-11
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-07-11
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2018-07-11
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2018-07-11
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2018-07-11
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2018-07-11
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2018-07-11
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2008-12-06
MRA	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented	Unknown	Class 3	N/A	2012-01-04
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2011-08-24
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2011-07-28
LZY	Prosthesis, Hip, Hemi-, Femoral, Metal Ball	Orthopedic	Class 2	888.3360	2012-03-21
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2008-07-28
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2010-02-24
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2008-12-06
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2017-06-29
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2017-06-29
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2009-07-14
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2009-07-14
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
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2007-12-03
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
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2011-01-11
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2011-01-11
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-05-20
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2019-05-20
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2007-06-14
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2007-12-06
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2007-12-06
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2007-12-03
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	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
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2007-12-03
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2010-02-24
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2011-08-24
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2011-08-24
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2007-12-06
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

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.

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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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006356043. Last updated year: 2026. Please use registration number 3006356043 when referencing this establishment in official correspondence.