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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 / September 2025 / K252085

510(k) cleared

Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)

Wright Medical Technology, Inc. (Stryker Corporation) · Sep 30, 2025 · K252085

FDA cleared the Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) from Wright Medical Technology, Inc. (Stryker Corporation) on Sep 30, 2025 under K252085, a traditional 510(k). The device falls under product code MQV, Filler, Bone Void, Calcium Compound, regulated at 21 CFR 888.3045 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jul 2, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Wright Medical Technology, Inc. (Stryker Corporation) has 2 other decisions in the tracker over the last 12 months: K253159 (Prophecy Incompass Surgical Planning System), K251643 (Synchfix EVT).

Questions & Answers

What did FDA clear under K252085?

K252085 is the FDA 510(k) for Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom), submitted by Wright Medical Technology, Inc. (Stryker Corporation). FDA's decision date was Sep 30, 2025, under product code MQV (Filler, Bone Void, Calcium Compound).

Who makes the Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)?

Wright Medical Technology, Inc. (Stryker Corporation), based in Memphis, TN, is the applicant of record for K252085.

How long did the K252085 review take?

FDA received the submission on Jul 2, 2025 and issued its decision on Sep 30, 2025, 90 days later.

← All decisions in September 2025

Sources