Integrity™ Implant
FDA 510(k) clearance K250997 · decided 2025-06-17
Clearance details
- K-number
- K250997
- Device name
- Integrity™ Implant
- Applicant
- Anika Therapeutics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-04-01
- Decision date
- 2025-06-17
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- OWX
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Beford, MA, 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 |
|---|---|---|
| FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit (K253867) | ZuriMED Technologies AG | 2026-01-02 |
| SuturePatch Tissue Reinforcement (K243480) | Arthrex, Inc. | 2025-05-29 |
| FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) (K241219) | ZuriMED Technologies AG | 2024-12-11 |
| Integrity Implant (K223538) | Anika Therapeutics, Inc. | 2023-08-17 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Ophthalin; Nuvisc; Anikavisc (P000046/S031) | Anika Therapeutics, Inc. | 2025-10-15 |
| Monovisc (P090031/S016) | Anika Therapeutics, Inc. | 2023-08-08 |
| Monovisc High Molecular Weight Hyaluronan (P090031/S015) | Anika Therapeutics, Inc. | 2022-11-08 |
| Orthovisc, Sodium Hyaluronic (P030019/S027) | Anika Therapeutics, Inc. | 2022-11-08 |
| Monovisc High Molecular Weight Hyaluronan (P090031/S014) | Anika Therapeutics, Inc. | 2022-11-04 |
| Monovisc High Molecular Weight Hyaluronan (P090031/S013) | Anika Therapeutics, Inc. | 2022-07-13 |
| Ophthalin, Anikavisc, Nuvisc (P000046/S030) | Anika Therapeutics, Inc. | 2021-12-22 |
| Nuvisc, Anikavisc, Ophthalin (P000046/S029) | Anika Therapeutics, Inc. | 2021-10-21 |