Triathlon Total Knee System
FDA 510(k) clearance K173849 · decided 2018-02-02
Clearance details
- K-number
- K173849
- Device name
- Triathlon Total Knee System
- Applicant
- Stryker Orthopaedics
- Decision
- Substantially Equivalent
- Date received
- 2017-12-19
- Decision date
- 2018-02-02
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- MBH
- Device class
- 2
- Regulation number
- 888.3565
- 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 |
|---|---|---|
| X3 TRIATHLON CS INSERT NO 3 10 MM recall (Z-1259-2024) | Howmedica Osteonics Corp. | 2024-03-06 |
| X3 TRIATHLON CS INSERT NO 6 10 MM recall (Z-1260-2024) | Howmedica Osteonics Corp. | 2024-03-06 |
| TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number recall (Z-1653-2023) | Howmedica Osteonics Corp. | 2023-05-30 |