TRIATHLON TRITANIUM TIBIAL BASEPLATE
FDA 510(k) clearance K123486 · decided 2013-05-03
Clearance details
- K-number
- K123486
- Device name
- TRIATHLON TRITANIUM TIBIAL BASEPLATE
- Applicant
- Stryker
- Decision
- Substantially Equivalent
- Date received
- 2012-11-13
- Decision date
- 2013-05-03
- Days to decision
- 171 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 |
|---|---|---|
| TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300. recall (Z-2461-2026) | Howmedica Osteonics Corp. | 2026-06-17 |
| TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400. recall (Z-2462-2026) | Howmedica Osteonics Corp. | 2026-06-17 |
| Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon Tritani recall (Z-1237-2022) | Howmedica Osteonics Corp. | 2022-06-03 |
| Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723 recall (Z-0249-2016) | Stryker Howmedica Osteonics Corp. | 2015-11-09 |
| Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal Capture Asse recall (Z-1283-2015) | Stryker Howmedica Osteonics Corp. | 2015-03-16 |