510(k) K936159 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
NATURAL-KNEE II SYSTEM
| Applicant | Intermedics Orthopedics, Austin TX, US |
| Decision | Substantially Equivalent for Some Indications, May 22, 1995 |
| Received | Dec 23, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K936159
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 29, 2017 | Zimmer Biomet, Inc. NP FEM LT SZ0 NATURAL-KNE
NP FEM RT SZ0 NATURAL-KNE
NP FEM LT SZ2 NATURAL-KNE
NP FEM RT SZ2 NATURAL-KNE
NP FEM LT SZ3 NATURAL-KNE
The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Terminated |
JWH | None listed |
| Feb 22, 2016 | Zimmer Biomet, Inc. NKII CSTI Porous Femoral
NKII NP Femoral
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
variou sizes
Product Usage "" The Natural-Knee II System with Cancello Terminated |
JWH | None listed |
| Mar 20, 2014 | Zimmer, Inc. Natural-Knee
N-K II DOMED ALL-POLY PAT, SZ0
N-K II DOMED ALL-POLY PAT, SZ1 Terminated |
JWH | None listed |
| Mar 20, 2014 | Zimmer, Inc. Natural-Knee II System:
POLY ULTRA TIB LT SZ00/9M
POLY ULTRA TIB LT SZ0/9MM
POLY ULTRA TIB LT SZ0/19M
POLY ULTRA TIB RT SZ0/13M
POLY ULTRA TIB RT SZ0/16M
ALL POLY ULTRA TIB LT SZ1
ALL POLY ULTRA TIB R Terminated |
JWH | None listed |
| Oct 25, 2013 | Zimmer, Inc. Natural-Knee Flex Femoral Component.
Provides increased flexion capability. Terminated |
JWH | None listed |
| Oct 25, 2013 | Zimmer, Inc. Natural-Knee II Femoral Component Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.