510(k) K072858 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
TC-PLUS PRIMARY KNEE SYSTEM
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Nov 20, 2007 |
| Received | Oct 5, 2007 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K072858
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 2 LEFT, STERILE R, REF 12 000 002, S&N 7500257, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | None listed |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 005, S&N 7500260, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | None listed |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 10 LEFT, STERILE R, REF 12 000 006, S&N 7500261, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | None listed |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 2 RIGHT, STERILE R, REF 12 000 009, S&N 7500264, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | None listed |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 0011, S&N 7500266, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | None listed |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 0012, S&N 7500267, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | None listed |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 0013, S&N 7500268, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | None listed |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R, REF 12 000 017, S&N 7500272, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | None listed |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 6 LEFT, STERILE R, REF 12 000 018, S&N 7500273, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | None listed |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 019, S&N 7500274, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | None listed |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 4 RIGHT, STERILE R, REF 12 000 024, S&N 7500279, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | None listed |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 025, S&N 7500280, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | None listed |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 026, S&N 7500281, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | None listed |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 027, S&N 7500282, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | None listed |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R, REF 12 000 028, S&N 7500283, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.