510(k) K031061 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 9, 2003 |
| Received | Apr 3, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031061
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2024 | Zimmer, Inc. NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System. Open, Classified |
JWH | None listed |
| Nov 29, 2017 | Zimmer Biomet, Inc. CR POR FEM HATCP
SIZE E/L
SIZE F/L
Knee Prosthesis Terminated |
MBH | None listed |
| Nov 29, 2017 | Zimmer Biomet, Inc. LPS POROUS FEM IMPLANT SZ G-L
LPS PRECOAT FEM IMPLANT SZ G-L
This device is indicated for patients with severe knee pain and disability Terminated |
NJL | None listed |
| Nov 29, 2017 | Zimmer Biomet, Inc. LPS PRECOAT SRF HDN FEM SZ D-L
LPS PRECOAT SRF HDN FEM SZ D-R
LPS PRECOAT SRF HDN FEM SZ E-L
LPS POROUS SRF HDN FEM SZ D-LT
LPS POROUS SRF HDN FEM SZ E-LT
This device is indicated for patients with s Terminated |
MBH | None listed |
| Nov 29, 2017 | Zimmer Biomet, Inc. LPS PRECOAT FEM SIZE D-RT
LPS PRECOAT FEM SIZE E-RT
LPS POROUS FEM SIZE F-RT
This device is indicated for patients with severe knee pain and disability Terminated |
NJL | None listed |
| Nov 29, 2017 | Zimmer Biomet, Inc. CR PRECOAT FEM COMP SIZE BMR
CR PRECOAT FEM COMP SIZE C/R
CR PRECOAT FEM COMP SIZE D/R
CR PRECOAT FEM COMP SIZE E/R
CR PRECOAT FEM COMP SIZE F/R
CR PRECOAT FEM COMP SIZE G/L
CR PRECOAT FEM COMP SIZE H Terminated |
JWH | None listed |
| Nov 29, 2017 | Zimmer Biomet, Inc. CR-FLEX POR FEM F-L
CR-FLEX POR FEM F-R MINUS
CR-FLEX POR FEM G-L
This device is indicated for patients with severe knee pain and disability Terminated |
MBH | None listed |
| Jul 27, 2012 | Zimmer Inc. Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile
Zimmer, Warsaw Indiana
The instrument is attached to the femoral implant or provisional to Terminated |
MBH | None listed |
| Jul 27, 2012 | Zimmer Inc. Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisional Impactor/Extractor, REF 00-5901-026-40, Non-Sterile Zimmer, Warsaw Indiana
The instrument is attached to the femora Terminated |
MBH | None listed |
| May 10, 2011 | Zimmer Inc. NEXGEN COMPLETE KNEE SOLUTION FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR, NONSTERILE, REF 00-5901-026-00, Zimmer UK, Ltd., Zimmer Warsaw, IN.
Intended use: The instrument is attached to the femoral Terminated |
MBH | None listed |
| May 10, 2011 | Zimmer Inc. NEXGEN COMPLETE KNEE SOLUTION FEMORAL REPLACEMENT JAW FOR USE WITH FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR , NONSTERILE, REF 00-5901-026-40, Zimmer UK, Ltd., Zimmer Warsaw, IN.
Intended use: The Terminated |
MBH | None listed |
| Apr 14, 2011 | Zimmer Inc. Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION, FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR, REF 00-5901-026-00, Zimmer UK, Ltd.,, Zimmer Warsaw,IN
This instrument is atta Terminated |
MBH | None listed |
| Apr 14, 2011 | Zimmer Inc. Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION POSTERIOR REFERENCING SIZER, REF 00-5901-040-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN
This instrument is attached Terminated |
MBH | None listed |
| Apr 14, 2011 | Zimmer Inc. Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION POSTERIOR REFERENCING SIZER Boom, REF 00-5901-040-10, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN
This instrument is att Terminated |
MBH | None listed |
| Apr 14, 2011 | Zimmer Inc. Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION PATELLA PEG DRILL GUIDE HANDLE, REF 00-5903-060-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN
This instrument is attac Terminated |
MBH | None listed |
| Apr 14, 2011 | Zimmer Inc. Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION QUICK-CONNECT HANDLE, REF 00-5901-034-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN
This instrument is attached to the Terminated |
MBH | None listed |
| Apr 14, 2011 | Zimmer Inc. Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION MODULAR T-HANDLE, REF 00-5901-061-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN
This instrument is attached to the fem Terminated |
MBH | None listed |
| Apr 14, 2011 | Zimmer Inc. Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION EXTRAMEDULLARY DISTAL
TELESCOPING TUBE, REF 00-5901-071-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN
This instrument Terminated |
MBH | None listed |
| Apr 14, 2011 | Zimmer Inc. Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION EXTRAMEDULLARY PROXIMAL TELESCOPING ROD, REF 00-5901-072-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN
This instrument Terminated |
MBH | None listed |
| Apr 14, 2011 | Zimmer Inc. Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION EXTRAMEDULLARY MODULAR SPIKE ARM POST, REF 00-5901-074-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN
This instrument i Terminated |
MBH | None listed |
| Apr 14, 2011 | Zimmer Inc. Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL RESECTION GUIDE, REF 00-5901-063-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN
This instrument is attac Terminated |
MBH | None listed |
| Apr 14, 2011 | Zimmer Inc. Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION FEMORAL VALGUS ALIGNMENT GUIDE, REF 00-5901-067-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN
This instrument is attac Terminated |
MBH | None listed |
| Apr 14, 2011 | Zimmer Inc. Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION PATELLA CLAMP, REF 00-5903-020-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN
This instrument is attached to the femora Terminated |
MBH | None listed |
| Apr 14, 2011 | Zimmer Inc. Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION PATELLA OSTEOTOMY GUIDE, REF 00-5903-010-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN
This instrument is attached to Terminated |
MBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.