Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components
FDA 510(k) clearance K172634 · decided 2017-11-16
Clearance details
- K-number
- K172634
- Device name
- Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components
- Applicant
- Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
- Decision
- Substantially Equivalent
- Date received
- 2017-09-01
- Decision date
- 2017-11-16
- Days to decision
- 76 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
+ Add to Predicate Builder ◉ Watch Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| X3 TRIATHLON CS INSERT NO 6 11 MM recall (Z-1261-2024) | Howmedica Osteonics Corp. | 2024-03-06 |
| X3 TRIATHLON CS INSERT NO 7 9 MM recall (Z-1262-2024) | Howmedica Osteonics Corp. | 2024-03-06 |
| NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM recall (Z-1263-2024) | Howmedica Osteonics Corp. | 2024-03-06 |
| NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM recall (Z-1264-2024) | Howmedica Osteonics Corp. | 2024-03-06 |
| NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM recall (Z-1265-2024) | Howmedica Osteonics Corp. | 2024-03-06 |
| NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM recall (Z-1266-2024) | Howmedica Osteonics Corp. | 2024-03-06 |
| TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number recall (Z-1654-2023) | Howmedica Osteonics Corp. | 2023-05-30 |