ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)
FDA 510(k) clearance K262251 · decided 2026-07-31
Clearance details
- K-number
- K262251
- Device name
- ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)
- Applicant
- Globus Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2026-07-01
- Decision date
- 2026-07-31
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Audubon, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Freedom Total Knee System (E-Poly Tibial Liners) (K261563) | Maxx Orthopedics, Inc. | 2026-08-07 |
| Klassic Infection Spacer System (K261734) | Total Joint Orthopedics, Inc. | 2026-07-23 |
| ATTUNE Total Knee System; ATTUNE Cementless Knee System (K261458) | DePuy Ireland UC | 2026-06-25 |
| NovoKnee (SteriKnee) (K261032) | NovoSource | 2026-04-27 |
| Materialise TKA Guide System (K253793) | Materialise NV | 2026-01-06 |
| EMPOWR Knee (K252974) | Encore Medical L.P. | 2025-12-19 |
| ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors (K253197) | Depuy Ireland UC | 2025-11-19 |
| Freedom Infinia™ Total Knee System (K253314) | Maxx Orthopedics, Inc. | 2025-10-29 |
| Freedom® Total Knee System – Titan PCK Components (K253144) | Maxx Orthopedics, Inc. | 2025-10-22 |
| Stem Extension Line (U2 Total Knee System—PSA Type) (K252725) | United Orthopedic Corporation | 2025-09-25 |
| Materialise TKA Guide System (K251554) | Materialise NV | 2025-07-14 |
| EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) (K251776) | Encore Medical L.P. | 2025-07-08 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SECURE®-C Cervical Artificial Disc (P100003/S008) | Globus Medical, Inc. | 2023-06-12 |
| SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S007) | Globus Medical, Inc. | 2017-08-18 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S006) | Globus Medical, Inc. | 2016-05-17 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S005) | Globus Medical, Inc. | 2014-12-18 |
| SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S004) | Globus Medical, Inc. | 2014-06-30 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S003) | Globus Medical, Inc. | 2014-05-08 |
| SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S002) | Globus Medical, Inc. | 2013-09-06 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S001) | Globus Medical, Inc. | 2013-03-15 |