ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)— 510(k) K262251
Substantially EquivalentGlobus Medical, Inc.
FDA 510(k) clearance K262251 for ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert), Substantially Equivalent on 2026-07-31. Applicant: Globus Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Globus Medical, Inc.
- 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
- Special
- Location
- Audubon, PA, US
Recent devices under product code JWH
view allMore clearances from Globus Medical, Inc.
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.