510(k) K070214 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 16, 2007 |
| Received | Jan 23, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070214
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 29, 2017 | Zimmer Biomet, Inc. GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS
N-K FLX GSF NP FEM SZ 0 RT
N-K FLX GSF NP FEM SZ 4 LT
N-K FLX GSF NP FEM SZ 4 RT
Compone Terminated |
JWH | None listed |
| Nov 29, 2017 | Zimmer Biomet, Inc. GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT
N-K FLX GSM POR FEM SZ 2 RT
N-K FLX GSM POR FEM SZ 3 LT
N-K FLX GSM POR FEM SZ 4 LT
N-K FLX GSM POR FEM SZ 4 RT
N-K FLX GSM POR Terminated |
MBH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 9 MM height, use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5424-010-09
Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 11 MM height, use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5424-010-11. Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 13 MM height, use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5424-010-13. Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 16 MM height, use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5424-010-16. Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 19 MM height, use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5424-010-19. Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 9 MM height, use with baseplate size 1 or 2, sterile, Zimmer, Warsaw, IN; REF 00-5424-011-09.
T Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 11 MM height, use with baseplate size 1 or 2, sterile, Zimmer, Warsaw, IN; REF 00-5424-011-11.
Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 13 MM height, for use with baseplate size 1 or 2 sterile, Zimmer, Warsaw, IN; REF 00-5424-011-1 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 16 MM height, for use with baseplate size 1 or 2 sterile, Zimmer, Warsaw, IN; REF 00-5424-011-1 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 19 MM height, for use with baseplate size 1 or 2 sterile, Zimmer, Warsaw, IN; REF 00-5424-011-1 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, left, 9 MM height, for use with baseplate size 3, 4 or 5, sterile, Zimmer, Warsaw, IN; REF 00-5424-0 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, left, 11 MM height, for use with baseplate size 3, 4 or 5, sterile, Zimmer, Warsaw, IN; REF 00-5424- Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, left, 13 MM height, for use with baseplate size 3, 4 or 5, sterile, Zimmer, Warsaw, IN; REF 00-5424- Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, left, 16 MM height, for use with baseplate size 3, 4 or 5, sterile, Zimmer, Warsaw, IN; REF 00-5424- Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, left,19 MM height, for use with baseplate size 3, 4 or 5, sterile, Zimmer, Warsaw, IN; REF 00-5424-0 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, right, 9 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5424-020 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, right, 11 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5424-02 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, right, 13 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5424-02 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, right, 16 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5424-02 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, right, 19 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5424-02 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1 or 2, right, 9 MM height, for use with baseplate size 1, 2, sterile, Zimmer, Warsaw, IN; REF 00-5424-021- Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, right, 11 MM height, for use with baseplate size 1 or 2, sterile, Zimmer, Warsaw, IN; REF 00-5424-021- Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, right, 13 MM height, for use with baseplate size 1 or 2, sterile, Zimmer, Warsaw, IN; REF 00-5424-021- Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, right, 16 MM height, for use with baseplate size 1 or 2, sterile, Zimmer, Warsaw, IN; REF 00-5424-021- Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, right, 19 MM height, for use with baseplate size 1 or 2, sterile, Zimmer, Warsaw, IN; REF 00-5424-021- Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, right, 9 MM height, for use with baseplate size 3, 4, or 5, sterile, Zimmer, Warsaw, IN; REF 00-5424 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, right, 11 MM height, for use with baseplate size 3, 4, or 5, sterile, Zimmer, Warsaw, IN; REF 00-542 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, right, 13 MM height, for use with baseplate size 3, 4, or 5, sterile, Zimmer, Warsaw, IN; REF 00-542 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, right, 16 MM height, for use with baseplate size 3, 4, or 5, sterile, Zimmer, Warsaw, IN; REF 00-542 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, right, 19 MM height, for use with baseplate size 3, 4, or 5, sterile, Zimmer, Warsaw, IN; REF 00-542 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, left, 9 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5428 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, left, 11 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-542 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, left, 13 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-542 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, left, 16 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-542 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, left, 19 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-542 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, left, 9 MM height, for use with baseplate size 1 or 2, sterile, Zimmer, Warsaw, IN; REF 00-5428-0 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, left, 11 MM height, for use with baseplate size 1 or 2, sterile, Zimmer, Warsaw, IN; REF 00-5428- Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, left, 13 MM height, for use with baseplate size 1 or 2, sterile, Zimmer, Warsaw, IN; REF 00-5428- Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, left, 16 MM height, for use with baseplate size 1 or 2, sterile, Zimmer, Warsaw, IN; REF 00-5428- Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, left, 19 MM height, for use with baseplate size 1 or 2, sterile, Zimmer, Warsaw, IN; REF 00-5428- Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, left, 9 MM height, for use with baseplate size 3, 4 or 5, sterile, Zimmer, Warsaw, IN; REF 00-5 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, left, 11 MM height, for use with baseplate size 3, 4 or 5, sterile, Zimmer, Warsaw, IN; REF 00- Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, left, 13 MM height, for use with baseplate size 3, 4 or 5, sterile, Zimmer, Warsaw, IN; REF 00- Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, left, 16 MM height, for use with baseplate size 3, 4 or 5, sterile, Zimmer, Warsaw, IN; REF 00- Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, left, 19 MM height, for use with baseplate size 3, 4 or 5, sterile, Zimmer, Warsaw, IN; REF 00- Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, right, 9 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-542 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, right, 11 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-54 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, right, 13 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-54 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, right, 16 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-54 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, right, 19 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-54 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, right, 9 MM height, for use with baseplate size 1 or 2, sterile, Zimmer, Warsaw, IN; REF 00-5428- Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, right, 11 MM height, for use with baseplate size 1 or 2, sterile, Zimmer, Warsaw, IN; REF 00-5428 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, right, 13 MM height, for use with baseplate size 1 or 2, sterile, Zimmer, Warsaw, IN; REF 00-5428 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, right, 16 MM height, for use with baseplate size 1 or 2, sterile, Zimmer, Warsaw, IN; REF 00-5428 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, right, 19 MM height, for use with baseplate size 1 or 2, sterile, Zimmer, Warsaw, IN; REF 00-5428 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, right, 9 MM height, for use with baseplate size 3,4 or 5, sterile, Zimmer, Warsaw, IN; REF 00-5 Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, right, 11 MM height, for use with baseplate size 3,4 or 5, sterile, Zimmer, Warsaw, IN; REF 00- Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, right, 13 MM height, for use with baseplate size 3,4 or 5, sterile, Zimmer, Warsaw, IN; REF 00- Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, right, 16 MM height, for use with baseplate size 3,4 or 5, sterile, Zimmer, Warsaw, IN; REF 00- Terminated |
JWH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, right, 19 MM height, for use with baseplate size 3,4 or 5, sterile, Zimmer, Warsaw, IN; REF 00- Terminated |
JWH | None listed |
| Jun 26, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural Knee Flex System, Gender Solutions Male, Femoral Component, nonporous, size 4, left, sterile, Zimmer, Warsaw, IN; Product Number: 00-5410-017-01.
Knee implant used to Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.