Triathlon Total Knee System— 510(k) K173849
Substantially EquivalentStryker Orthopaedics
FDA 510(k) clearance K173849 for Triathlon Total Knee System, Substantially Equivalent on 2018-02-02. Applicant: Stryker Orthopaedics. Device class: 2.
Clearance details
- Applicant
- 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 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 K173849
K-number listed on FDA's recall record- Z-1259-2024 — X3 TRIATHLON CS INSERT NO 3 10 MM
- Z-1260-2024 — X3 TRIATHLON CS INSERT NO 6 10 MM
- Z-1653-2023 — TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173849.
Data sourced from openFDA. This site is unofficial and independent of the FDA.