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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / January 2026 / K251214

510(k) cleared

BEAR® (Bridge-Enhanced ACL Restoration) Implant

Miach Orthopaedics, Inc. · Jan 13, 2026 · K251214 · In the directory

FDA cleared the BEAR® (Bridge-Enhanced ACL Restoration) Implant from Miach Orthopaedics, Inc. on Jan 13, 2026 under K251214, a traditional 510(k). The device falls under product code QNI, Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair, regulated at 21 CFR 888.3044 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Apr 18, 2025. The decision came 270 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Miach Orthopaedics, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251214?

K251214 is the FDA 510(k) for BEAR® (Bridge-Enhanced ACL Restoration) Implant, submitted by Miach Orthopaedics, Inc.. FDA's decision date was Jan 13, 2026, under product code QNI (Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair).

Who makes the BEAR® (Bridge-Enhanced ACL Restoration) Implant?

Miach Orthopaedics, Inc., based in Westborough, MA, is the applicant of record for K251214. The company is listed in the MedDevice Startups directory.

How long did the K251214 review take?

FDA received the submission on Apr 18, 2025 and issued its decision on Jan 13, 2026, 270 days later.

← All decisions in January 2026

Sources

In the startup directory

Miach Orthopaedics

Orthopedics & Spine · Westborough, MA