# K252085: Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)

- Pathway: 510(k) (Traditional)
- Applicant: Wright Medical Technology, Inc. (Stryker Corporation)
- Decided: Sep 30, 2025 after 90 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K040980 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041168: Allomatrix Putty, Wrightmedicaltechnologyinc (2004) Summary page 5.
- K040980: Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite Scaffold, Models 860C, 86XC, 86DR, 860D, 860T, Wrightmedicaltechnologyinc (2004) Summary page 5.
- K061939: Modification to Allomatrix Custom, Wrightmedicaltechnologyinc (2006) Summary page 5.

## Indications for use
Allomatrix® Injectable Putty, Allomatrix C, and Allomatrix® DR products are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Allomatrix® products are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. AlloMatrix® Custom Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of bony structure. AlloMatrix® Custom Putty is intended to be gently packed into bony voids or gaps of the skeletal system as a bone graft extender (spine), and as a bone void filler in the extremities and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Source page: https://510kreport.com/device/K252085
Methodology: https://510kreport.com/methodology