BEAR® (Bridge-Enhanced ACL Restoration) Implant
FDA 510(k) clearance K243578 · decided 2025-03-06
Clearance details
- K-number
- K243578
- Device name
- BEAR® (Bridge-Enhanced ACL Restoration) Implant
- Applicant
- Miach Orthopaedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-11-19
- Decision date
- 2025-03-06
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- QNI
- Device class
- 2
- Regulation number
- 888.3044
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Westborough, 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 |
|---|---|---|
| BEAR® (Bridge-Enhanced ACL Restoration) Implant (K251214) | Miach Orthopaedics, Inc. | 2026-01-13 |
| BEAR (Bridge-Enhanced ACL Repair) Implant (DEN200035) | Miach Orthopaedics, Inc. | 2020-12-16 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BEAR Implant. Model Number: 1000. recall (Z-1220-2026) | Miach Orthopaedics | 2026-01-29 |
| BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000; recall (Z-0479-2026) | Miach Orthopaedics | 2025-11-07 |