# K053319: Allomatrix Custom

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Mar 6, 2006 after 96 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) autologous iliac crest bone: named in the summary without a submission number

## Most influential descendants
- K113728: Surfuse Gel and Putty, Exfuse Gel and Putty (2012), 4 descendants of its own
- K171568: SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty (2018), 0 descendants of its own
- K152077: MaxiGen (2016), 0 descendants of its own
- K151271: BellaFuse (2016), 0 descendants of its own
- K130235: Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II Putty (2014), 0 descendants of its own

## Indications for use
ALLOMATRIX ® Custom is indicated only for bony voids or gaps that are not intrinsic to the stability of bony structure. ALLOMATRIX® Custom 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/K053319
Methodology: https://510kreport.com/methodology