Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component— 510(k) K241716
Substantially EquivalentHowmedica Osteonics Corp., Dba Stryker Orthopaedics
FDA 510(k) clearance K241716 for Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component, Substantially Equivalent on 2024-08-02. Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Device class: 2.
Clearance details
- Applicant
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Product code
- Code JDI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3350
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mahwah, NJ, US
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More clearances from Howmedica Osteonics Corp., Dba Stryker Orthopaedics
view all- K261898 — Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System
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- K252898 — Triathlon® Tritanium® Asymmetric Patella +5 more
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Adverse events under product code JDI
product code JDI- Death
- 65
- Injury
- 12,943
- Malfunction
- 1,681
- Total
- 14,689
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.