510(k) K043101 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 7, 2005 |
| Received | Nov 9, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043101
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 50 consists of all product under product code: JWH and same usage:
Item no:
595002701 NEXGEN MIS TIBIA PLATE PR
595002702 NEXGEN MIS TIBIA PLATE PR
595003701 NEXGEN MIS TIBIA PLATE PR
595003 Terminated |
JWH | None listed |
| Jun 27, 2014 | Zimmer, Inc. NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 1. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthes Terminated |
JWH | None listed |
| Jun 27, 2014 | Zimmer, Inc. NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 2. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthes Terminated |
JWH | None listed |
| Jun 27, 2014 | Zimmer, Inc. NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 3. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthes Terminated |
JWH | None listed |
| Jun 27, 2014 | Zimmer, Inc. NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthes Terminated |
JWH | None listed |
| Jun 27, 2014 | Zimmer, Inc. NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4+. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthe Terminated |
JWH | None listed |
| Jun 27, 2014 | Zimmer, Inc. NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 5. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthes Terminated |
JWH | None listed |
| Jun 27, 2014 | Zimmer, Inc. NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 6. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthes Terminated |
JWH | None listed |
| Jun 27, 2014 | Zimmer, Inc. NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 7. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthes Terminated |
JWH | None listed |
| Jun 27, 2014 | Zimmer, Inc. NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 8. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthes Terminated |
JWH | None listed |
| Feb 20, 2014 | Zimmer, Inc. MODULAR CUP NEUTRAL LINER
MODULAR CUP 10 DEGREE LIN
MODULAR CUP 20 DEGREE LIN
MODULAR CUP 7MM OFFSET LI Terminated |
LPH | None listed |
| Sep 13, 2010 | Zimmer Inc. NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 1, sterile, REF 00-5950-027-01, Zimmer Inc. Warsaw, IN.
This device is indicated for patients Terminated |
JWH | None listed |
| Sep 13, 2010 | Zimmer Inc. NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 2, sterile, REF 00-5950-027-02, Zimmer Inc. Warsaw, IN.
This device is indicated for patient Terminated |
JWH | None listed |
| Sep 13, 2010 | Zimmer Inc. NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 3, sterile, REF 00-5950-037-01, Zimmer Inc. Warsaw, IN.
This device is indicated for patients Terminated |
JWH | None listed |
| Sep 13, 2010 | Zimmer Inc. NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 4, sterile, REF 00-5950-037-02, Zimmer Inc. Warsaw, IN.
This device is indicated for patients Terminated |
JWH | None listed |
| Sep 13, 2010 | Zimmer Inc. NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 5, sterile, REF 00-5950-047-01, Zimmer Inc. Warsaw, IN.
This device is indicated for patients Terminated |
JWH | None listed |
| Sep 13, 2010 | Zimmer Inc. NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 6, sterile, REF 00-5950-047-02, Zimmer Inc. Warsaw, IN.
This device is indicated for patients Terminated |
JWH | None listed |
| Sep 13, 2010 | Zimmer Inc. NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 7 sterile, REF 00-5950-057-01, Zimmer Inc. Warsaw, IN.
This device is indicated for patients Terminated |
JWH | None listed |
| Sep 13, 2010 | Zimmer Inc. NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 8, sterile, REF 00-5950-057-02, Zimmer Inc. Warsaw, IN.
This device is indicated for patients Terminated |
JWH | None listed |
| Sep 13, 2010 | Zimmer Inc. NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 4+ (Plus), sterile, REF 00-5950-037-12, Zimmer Inc. Warsaw, IN.
This device is indicated for Terminated |
JWH | None listed |
| Sep 13, 2010 | Zimmer Inc. NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 9, sterile, REF 00-5950-057-03, Zimmer Inc. Warsaw, IN.
This device is indicated for patients Terminated |
JWH | None listed |
| Sep 13, 2010 | Zimmer Inc. NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 10, sterile, REF 00-5950-057-04, Zimmer Inc. Warsaw, IN.
This device is indicated for patient Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.