TRIATHLON TOTAL KNEE SYSTEM
FDA 510(k) clearance K053514 · decided 2006-01-26
Clearance details
- K-number
- K053514
- Device name
- TRIATHLON TOTAL KNEE SYSTEM
- Applicant
- Stryker Orthopaedics
- Decision
- Substantially Equivalent
- Date received
- 2005-12-16
- Decision date
- 2006-01-26
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mahwah, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Siz recall (Z-0964-2013) | Stryker Howmedica Osteonics Corp. | 2013-03-18 |
| Triathlon Cemented Stem - Knee These devices are modular components of a total knee system recall (Z-0889-2009) | Stryker Howmedica Osteonics Corp. | 2009-01-26 |