Cleared Traditional

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

K252085 · Wright Medical Technology, Inc. (Stryker Corporation) · Orthopedic

Sep 2025

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K252085 is an FDA 510(k) clearance for the Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom), a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Wright Medical Technology, Inc. (Stryker Corporation) (Memphis, US). The FDA issued a Cleared decision on September 30, 2025, 90 days after receiving the submission on July 2, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number	K252085 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 02, 2025
Decision Date	September 30, 2025
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF