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BEAR® (Bridge-Enhanced ACL Restoration) Implant

by Miach Orthopaedics, Inc. 2 variants

510(k) K243578

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK243578 Date6 Mar 2025ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-1220-2026 FDA Class II initiated 31 Dec 2025

    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.

    • Ongoing Z-0479-2026 FDA Class II initiated 2 Feb 2023

    The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
QNI
Device Class
Class II
Regulation
21 CFR Part 888.3044
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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