Panels › Orthopedic › Product code JWH · Class 2

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Regulation 888.3560

14510(k)s in 12 months (921 all time)

7recalls in 12 months (985 all time)

888recalls that name a 510(k)

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Top companies in JWH

Company	510(k)s	Recalls
Zimmer, Inc.	51	304
DePuy Orthopaedics, Inc.	16	102
Smith & Nephew, Inc.	49	60
Exactech, Inc.	32	64
Howmedica Osteonics	32	61
Zimmer Biomet, Inc.	0	85
Biomet, Inc.	40	44
Stryker Howmedica Osteonics	0	64
Conformis, Inc.	40	19
Encore Medical L.P.	15	44

Date	Firm and product	Code	Linked 510(k)
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, stabilized tibial insert (STAB); polyethylene tibial insert, Sz 3, 20.0 mm; Ref 98-6065. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, stabilized tibial insert (STAB); polyethylene tibial insert, Sz 3, 12.5 mm; Ref 98-6062. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, stabilized tibial insert (STAB); polyethylene tibial insert, Sz 2, 22.5 mm; Ref 98-6056. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, stabilized tibial insert (STAB); polyethylene tibial insert, Sz 2, 12.5 mm; Ref 98-6052. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, stabilized tibial insert (STAB); polyethylene tibial insert, Sz 2, 8.0 mm; Ref 98-6050. Terminated	JWH	None listed
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, posterior-lipped tibial insert (PLI); polyethylene tibial insert, Sz 5, 15.0 mm; Ref 98-4626. Terminated	JWH	K884796
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, posterior-lipped tibial insert (PLI); polyethylene tibial insert, Sz 5, 8.0 mm; Ref 98-4623. Terminated	JWH	K884796
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, posterior-lipped tibial insert (PLI); polyethylene tibial insert, Sz 5, 10.0 mm; Ref 98-4624. Terminated	JWH	K884796
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, posterior-lipped tibial insert (PLI); polyethylene tibial insert, Sz 4, 12.5 mm; Ref 98-4618. Terminated	JWH	K884796
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, posterior-lipped tibial insert (PLI); polyethylene tibial insert, Sz 3, 12.5 mm; Ref 98-4610. Terminated	JWH	K884796
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 6, 15.0 mm; Ref 98-4198. Terminated	JWH	K884796
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 5, 8.0 mm; Ref 98-4157. Terminated	JWH	K884796
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 5, 10.0 mm; Ref 98-4158. Terminated	JWH	K884796
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 4, 12.5 mm; Ref 98-4154. Terminated	JWH	K884796
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 3, 17.5 mm; Ref 98-4151. Terminated	JWH	K884796
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 4, 8.0 mm; Ref 98-4152. Terminated	JWH	K884796
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 2, 8.0 mm; Ref 98-4142. Terminated	JWH	K884796
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 2, 10.0 mm; Ref 98-4143. Terminated	JWH	K884796
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 2, 12.5 mm; Ref 98-4144. Terminated	JWH	K884796
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 1, 10.0 mm; Ref 98-4031. Terminated	JWH	K884796
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 5, 15.0 mm; Ref 97-0373. Terminated	JWH	K961685
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 5, 10.0 Ref 97-0371. Terminated	JWH	K961685
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 4, 10 mm; Ref 97-0361. Terminated	JWH	K961685
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 15.0 mm; Ref 97-0353. Terminated	JWH	K961685
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 12.5 mm; Ref 97-0352. Terminated	JWH	K961685
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 2.5, 8 mm; Ref 97-0340. Terminated	JWH	K961685
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 5, 22.5 mm; Ref 1581-25-022. Terminated	JWH	K033272
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 5, 12.5 mm; Ref 1581-25-012. Terminated	JWH	K033272
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 5, 10 mm; Ref 1581-25-010. Terminated	JWH	K033272
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 22.5 mm; Ref 1581-24-022. Terminated	JWH	K033272
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 17.5 mm; Ref 1581-24-017. Terminated	JWH	K033272
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 15 mm; Ref 1581-24-015. Terminated	JWH	K033272
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 12.5 mm; Ref 1581-24-012. Terminated	JWH	K033272
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 10 mm; Ref 1581-24-010. Terminated	JWH	K033272
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 8 mm; Ref 1581-24-008. Terminated	JWH	K033272
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 3, 17.5 mm; Ref 1581-23-017. Terminated	JWH	K033272
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 3, 15 mm; Ref 1581-23-015. Terminated	JWH	K033272
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 3, 12.5 mm; Ref 1581-23-012. Terminated	JWH	K033272
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 3, 10 mm; Ref 1581-23-010. Terminated	JWH	K033272
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 2.5, 12.5 mm; Ref 1581-22-012. Terminated	JWH	K033272
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 2.5, 10 mm; Ref 1581-22-010. Terminated	JWH	K033272
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 2.5, 8 mm; Ref 1581-22-008. Terminated	JWH	K033272
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 2, 20 mm; Ref 1581-21-020. Terminated	JWH	K033272
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 2, 15 mm; Ref 1581-21-015. Terminated	JWH	K033272
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 1.5, 15 mm; Ref 1581-20-015. Terminated	JWH	K033272
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 1.5, 8 mm; Ref 1581-20-008. Terminated	JWH	K033272
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 6, 12.5 mm; Ref 1581-16-012. Terminated	JWH	K033272
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 5, 17.5 mm; Ref 1581-15-017. Terminated	JWH	K033272
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 5, 15 mm; Ref 1581-15-015. Terminated	JWH	K033272
Aug 12, 2005	Depuy Orthopaedics, Inc. Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 5, 12.5 mm; Ref 1581-15-012. Terminated	JWH	K033272

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