# Miach Orthopaedics, Inc.

- Location (FDA's records): Westborough, MA
- FDA decisions: 3 (2020–2026): 2 510(k) clearances and 1 De Novo grant
- Product codes: QNI (3)
- Predicates its devices cite: 2 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Its most-cited devices
- K243578: BEAR® (Bridge-Enhanced ACL Restoration) Implant (2025), cited by 1
- DEN200035: BEAR (Bridge-Enhanced ACL Repair) Implant (2020), cited by 1

## Recent decisions
- K251214: BEAR® (Bridge-Enhanced ACL Restoration) Implant (Jan 13, 2026)
- K243578: BEAR® (Bridge-Enhanced ACL Restoration) Implant (Mar 6, 2025)
- DEN200035: BEAR (Bridge-Enhanced ACL Repair) Implant (Dec 16, 2020)

Source page: https://510kreport.com/company/miach-orthopaedics