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

FDA 510(k) K252085 · Wright Medical Technology, Inc. (Stryker Corporation)

Substantially Equivalent

510(k) numberK252085

Submission

Device name
Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)
Applicant
Wright Medical Technology, Inc. (Stryker Corporation)
Memphis, TN, US
Received
July 2, 2025
Decision date
September 30, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MQV – Filler, Bone Void, Calcium Compound
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3045
Specialty
Orthopedic
Implant
Yes

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K252797JAZBI™ Resorbable Bone Void FillerMQV · Traditional Sdip Innovations Pty, Ltd.05/26/2026SE
K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…MQV · Special Stryker Spine04/24/2026SE
K253524Adaptos®Fuse Bone GraftMQV · Traditional Biomendex OY02/17/2026SE
K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…MQV · Special Prosidyan, Inc.10/22/2025SE
K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™MQV · Traditional Bone Solutions, Inc.10/13/2025SE
K251556Device 300423 GranulesMQV · Traditional Geistlich Pharma AG07/17/2025SE
K251720OsteoFlo HydroFiberMQV · Special SurGenTec, LLC07/02/2025SE
K251193Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone GraftMQV · Traditional Medtronic Sofamor Danek, Inc.06/12/2025SE

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Questions and answers

When was Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) cleared by the FDA?

Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) (K252085) received a 510(k) decision of Substantially Equivalent on September 30, 2025, 90 days after the submission was received.

What is the product code of K252085?

The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.