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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / January 2026 / K251214

510(k) cleared

BEAR® (Bridge-Enhanced ACL Restoration) Implant

Miach Orthopaedics, Inc. · Jan 13, 2026 · K251214

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.

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