# K041663: Allomatrix TCP, Allomatrix W/CASO4 Filled TCP, and Allomatrix Plus CBM

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Sep 16, 2004 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP, and ALLOMATRIX ® PLUS CBM are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP and ALLOMATRIX ® PLUS CBM 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.

Source page: https://510kreport.com/device/K041663
Methodology: https://510kreport.com/methodology