Data / Medical devices / United States / Miach Orthopaedics
Miach Orthopaedics: FDA-registered device maker in Westborough, MA, United States, 3 510(k) clearances
Miach Orthopaedics is registered with the FDA (registration 3020652309) in Westborough, MA, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated January 13, 2026. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020652309
- Address
- 69 Milk Street Suite 100, Westborough, MA, United States, 01581
- Owner or operator
- Miach Orthopaedics (10082865)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- October 8, 2021
- Registered through
- 2026
- Brand names listed
- BEAR Implant, BEAR® (Bridge-Enhanced ACL Repair) Implant
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair | QNI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 13, 2026 | K251214 | BEAR® (Bridge-Enhanced ACL Restoration) Implant | QNI | Substantially Equivalent | Miach Orthopaedics, Inc. | accessdata.fda.gov |
| March 6, 2025 | K243578 | BEAR® (Bridge-Enhanced ACL Restoration) Implant | QNI | Substantially Equivalent | Miach Orthopaedics, Inc. | accessdata.fda.gov |
| December 16, 2020 | DEN200035 | BEAR (Bridge-Enhanced ACL Repair) Implant | QNI | Unknown | Miach Orthopaedics, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 31, 2025 | 98280 | Class II | Ongoing | BEAR Implant. Model Number: 1000. | Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect. | accessdata.fda.gov |
| February 2, 2023 | 97742 | Class II | Ongoing | BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000 | The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only. | accessdata.fda.gov |
Updated January 29, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.