# K022629: WMT-TCP Bone Graft Substitute

- Pathway: 510(k) (Abbreviated)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Nov 5, 2002 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 K013966 (2002). 1 ancestor in all.
58 later devices descend from it; 3 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013966: Apatight-TCP Bone Graft Substitute, Cerabio, LLC (2002)

## Most influential descendants
- K031817: Cellplex TCP Synthetic Cancellous Bone (2003), 52 descendants of its own
- K043261: Harvest Graft Delivery Syringe (2005), 51 descendants of its own
- K100754: Graft Delivery System Model SA-6115 (2010), 45 descendants of its own
- K111632: Infill Graft Delivery System (2011), 41 descendants of its own
- K121476: Infill Graft Delivery System (2012), 40 descendants of its own

## Indications for use
WMT- TCP Bone Graft is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. The WMT-TCP is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. WMT- TCP Bone Graft Substitute can be combined with autogenous bone marrow aspirate and/or biood. The product resorbs and is replaced with bone during the healing process. The WMT- TCP Bone Graft Substitute is provided sterile for single use only and should not be resterilized.

Source page: https://510kreport.com/device/K022629
Methodology: https://510kreport.com/methodology