# K083270: WMT Composite DBM

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Aug 27, 2009 after 294 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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) Allomatrix: named in the summary without a submission number

## Most influential descendants
- K190283: PROSTIM Injectable Inductive Graft (2019), 2 descendants of its own
- K200507: PRO-DENSE LoVisc Bone Graft Substitute (2020), 1 descendant of its own
- K213342: PRO-DENSE LoVisc Bone Graft Substitute (2022), 0 descendants of its own

## Recalls of this device
- Nov 8, 2016 · Class II · Z-0564-2020: The firm discovered a lack of adequate documentation confirming sterility on certain products.

## Indications for use
WMT Composite DBM resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in-situ. These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process. The WMT Composite DBM paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process. The WMT Composite DBM Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced by bone during the healing process. The bone void filler included in the WMT Composite DBM Core Decompression Kit is not intended to be used as a load bearing device. WMT Composite DBM is provided sterile for single use only.

Source page: https://510kreport.com/device/K083270
Methodology: https://510kreport.com/methodology