510(k) K070095 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
TRIATHLON TS KNEE SYSTEM
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Jun 1, 2007 |
| Received | Jan 10, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070095
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2015 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Triathlon femoral component.
Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile.
For use in total reconstructive replacement of the knee joint Terminated |
JWH | None listed |
| May 23, 2013 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package
Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA
Stryker France, ZAC Satolas Green Pusignan Terminated |
JWH | None listed |
| Feb 1, 2010 | Stryker Howmedica Osteonics Corp. Triathlon Total Stabilizer Femoral Component; Size # 2
for Use with TS Components; Sterile, Made in the USA
Stryker Orthopaedics, Mahwah, NJ 07430.
The Triathlon Total Knee System components are int Terminated |
JWH | None listed |
| Feb 1, 2010 | Stryker Howmedica Osteonics Corp. Triathlon Total Stabilizer Femoral Component; For Use with TS Components; Sterile, Made in the USA
Stryker Orthopaedics, Mahwah, NJ 07430.
The Triathlon Total Knee System components are intended for Terminated |
JWH | None listed |
| Feb 1, 2010 | Stryker Howmedica Osteonics Corp. Triathlon Total Stabilizer Femoral Component;
For Use with TS Components; Sterile, Made in the USA
Stryker Orthopaedics, Mahwah, NJ 07430.
The Triathlon Total Knee System components are intended fo Terminated |
JWH | None listed |
| Feb 1, 2010 | Stryker Howmedica Osteonics Corp. Triathlon Total Stabilizer Femoral Component;
For Use with TS Components; Sterile, Made in the USA
Stryker Orthopaedics, Mahwah, NJ 07430.
The Triathlon Total Knee System components are intended fo Terminated |
JWH | None listed |
| Feb 1, 2010 | Stryker Howmedica Osteonics Corp. Triathlon Total Stabilizer Femoral Component;
For Use with TS Components; Sterile, Made in the USA
Stryker Orthopaedics, Mahwah, NJ 07430.
The Triathlon Total Knee System components are intended fo Terminated |
JWH | None listed |
| Jul 23, 2009 | Stryker Howmedica Osteonics Corp. Offset Adaptor Trial - 2MM, Triathlon Revision Instruments. Non-Sterile; Howmedica Osteonics Corp: 325 Corporate Drive, Mahwah, NJ 07430.
Indications for use include disabling joint disease of the k Terminated |
JWH | None listed |
| Jul 23, 2009 | Stryker Howmedica Osteonics Corp. Offset Adaptor Trial - 4MM, Triathlon Revision Instruments. Non-Sterile; Howmedica Osteonics Corp: 325 Corporate Drive, Mahwah, NJ 07430.
Indications for use include disabling joint disease of the kn Terminated |
JWH | None listed |
| Jul 23, 2009 | Stryker Howmedica Osteonics Corp. Offset Adaptor Trial - 6MM, Triathlon Revision Instruments. Non-Sterile; Howmedica Osteonics Corp: 325 Corporate Drive, Mahwah, NJ 07430.
Indications for use include disabling joint disease of the kn Terminated |
JWH | None listed |
| Jul 23, 2009 | Stryker Howmedica Osteonics Corp. Offset Adaptor Trial - 8MM, Triathlon Revision Instruments. Non-Sterile; Howmedica Osteonics Corp: 325 Corporate Drive, Mahwah, NJ 07430.
Indications for use include disabling joint disease of the k Terminated |
JWH | None listed |
| Jan 26, 2009 | Stryker Howmedica Osteonics Corp. Triathlon-Press-Fit Stem
These devices are modular components of a total knee system. These modular stems are intended for use with femoral and tibial components in primary or revision total knee art Terminated |
JWH | None listed |
| Sep 25, 2007 | Stryker Howmedica Osteonics Corp. Triathlon X3
Total Stabilizer + Tibial Insert
For use with Triathlon Universal Baseplates, knee prosthesis.
#5 13mm
Stryker Orthopaedics Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.