BEAR® (Bridge-Enhanced ACL Restoration) Implant— 510(k) K251214

Name: FDA 510(k) clearance K251214
Creator: U.S. Food and Drug Administration
Published: 2026-01-13

Substantially Equivalent

Miach Orthopaedics, Inc.

FDA 510(k) clearance K251214 for BEAR® (Bridge-Enhanced ACL Restoration) Implant, Substantially Equivalent on 2026-01-13. Applicant: Miach Orthopaedics, Inc.. Device class: 2.

Clearance details

Applicant: Miach Orthopaedics, Inc.
Product code: Code QNI
Device class: Class 2
Regulation: 21 CFR 888.3044
Advisory panel: Orthopedic
Date received: 2025-04-18
Decision date: 2026-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westborough, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QNI

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K243578 — BEAR® (Bridge-Enhanced ACL Restoration) Implant2025-03-06
DEN200035 — BEAR (Bridge-Enhanced ACL Repair) Implant2020-12-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.