510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243578Substantially Equivalent

BEAR® (Bridge-Enhanced ACL Restoration) Implant

Miach Orthopaedics, Westborough MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243578 is the FDA 510(k) clearance record for BEAR® (Bridge-Enhanced ACL Restoration) Implant, a class II device, cleared for Miach Orthopaedics, Inc. on under FDA product code QNI (Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair). FDA's definition for product code QNI reads: "A resorbable implant for anterior cruciate ligament (ACL) repair is a degradable material that allows for healing of a torn ACL that is biomechanically stabilized by traditional suturing procedures. The device is intended to protect the...". FDA records list 3 510(k) clearances for Miach Orthopaedics, Inc., from to . As of , FDA records show 2 recalls naming K243578.

Clearance record

Decision date
Received
(107 days to decision)
Product code
QNI Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
Regulation
21 CFR 888.3044
Device class
Class II
Review panel
Orthopedic
Applicant
Miach Orthopaedics, Inc. 69 Milk St., Suite 100, Westborough MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QNI

Trailing 12 months
1 clearance under product code QNI in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QNI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260