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FDA 510(k)

BEAR® (Bridge-Enhanced ACL Restoration) Implant

K-Number: K243578 · 2025-03-06

ApplicantMiach Orthopaedics, Inc.
Decision Date2025-03-06
Product CodeQNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BEAR® (Bridge-Enhanced ACL Restoration) Implant is the device name listed in this FDA 510(k) record. The listed applicant is Miach Orthopaedics, Inc.. It received FDA 510(k) clearance on 2025-03-06 under 510(k) number K243578. The device is classified under product code QNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEAR® (Bridge-Enhanced ACL Restoration) Implant?

BEAR® (Bridge-Enhanced ACL Restoration) Implant is a medical device that received FDA 510(k) clearance on 2025-03-06. The listed applicant is Miach Orthopaedics, Inc.. The 510(k) number is K243578.

When did BEAR® (Bridge-Enhanced ACL Restoration) Implant receive FDA 510(k) clearance?

BEAR® (Bridge-Enhanced ACL Restoration) Implant received FDA 510(k) clearance on 2025-03-06, under 510(k) number K243578.

Who is the listed applicant for BEAR® (Bridge-Enhanced ACL Restoration) Implant?

The FDA 510(k) record lists Miach Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BEAR® (Bridge-Enhanced ACL Restoration) Implant?

The FDA product code for BEAR® (Bridge-Enhanced ACL Restoration) Implant is QNI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT03348995The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) RestorationACTIVE_NOT_RECRUITINGNCT05398341A Prospective Cohort Post Market Registry Evaluating Outcomes of Bridge-Enhanced ACL Restoration (BEAR®)ACTIVE_NOT_RECRUITINGNCT02292004Bridge-Enhanced ACL Repair-Safety Study (BEAR Trial)ACTIVE_NOT_RECRUITINGNCT03776162A Comparison of ACL Repair With BEAR Device vs. Autograft Patellar Tendon ACL ReconstructionACTIVE_NOT_RECRUITINGNCT07212855Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge ProtocolCOMPLETED

Other records listing Miach Orthopaedics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251214BEAR® (Bridge-Enhanced ACL Restoration) Implant

Related Devices (Code: QNI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251214BEAR® (Bridge-Enhanced ACL Restoration) ImplantMiach Orthopaedics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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