QNI

Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair

Product code: QNI
Device name: Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
Device class: Class 2
21 CFR: 21 CFR 888.3044
Medical specialty: Orthopedic
Marketing pathway: 510(K)
Flag: Implant
510(k) clearances (last 3 years): 3

FDA classification definition

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 biological healing process from the surrounding intraarticular environment and not intended to replace biomechanical fixation via suturing. This classification includes devices that bridge or surround the torn ends of a ruptured ACL.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-01-13.

Number	Decision date	Applicant	Device name	Summary
K251214	2026-01-13	Miach Orthopaedics, Inc.	BEAR® (Bridge-Enhanced ACL Restoration) Implant	PDF
K243578	2025-03-06	Miach Orthopaedics, Inc.	BEAR® (Bridge-Enhanced ACL Restoration) Implant	FDA

1 summaries are archived here for direct download.

Official FDA classification page: QNI

Classification and pathway per current FDA publications. Data from openFDA (CC0).