TRIATHLON TOTAL KNEE SYSTEM— 510(k) K053514
Substantially EquivalentStryker Orthopaedics
FDA 510(k) clearance K053514 for TRIATHLON TOTAL KNEE SYSTEM, Substantially Equivalent on 2006-01-26. Applicant: Stryker Orthopaedics. Device class: 2.
Clearance details
- Applicant
- Stryker Orthopaedics
- Product code
- Code JWH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3560
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mahwah, NJ, US
Recent devices under product code JWH
view allMore clearances from Stryker Orthopaedics
view allAdverse events under product code JWH
product code JWH- Death
- 26
- Injury
- 51,564
- Malfunction
- 9,725
- Other
- 9
- Total
- 61,324
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 K053514
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K053514.
Data sourced from openFDA. This site is unofficial and independent of the FDA.