Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components— 510(k) K172634
Substantially EquivalentHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
FDA 510(k) clearance K172634 for Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components, Substantially Equivalent on 2017-11-16. Applicant: Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. Device class: 2.
Clearance details
- Applicant
- Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
- Product code
- Code MBH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3565
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mahwah, NJ, US
Recent devices under product code MBH
view allMore clearances from Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
view allAdverse events under product code MBH
product code MBH- Injury
- 6,545
- Malfunction
- 2,023
- Total
- 8,568
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K172634
K-number listed on FDA's recall record- Z-1261-2024 — X3 TRIATHLON CS INSERT NO 6 11 MM
- Z-1262-2024 — X3 TRIATHLON CS INSERT NO 7 9 MM
- Z-1263-2024 — NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
- Z-1264-2024 — NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
- Z-1265-2024 — NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
- Z-1266-2024 — NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
- Z-1654-2023 — TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172634.
Data sourced from openFDA. This site is unofficial and independent of the FDA.