# K031817: Cellplex TCP Synthetic Cancellous Bone

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jul 17, 2003 after 35 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: 2 generations back to K013966 (2002). 3 ancestors in all.
52 later devices descend from it; 1 cites it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022629: WMT-TCP Bone Graft Substitute, Wrightmedicaltechnologyinc (2002) Summary page 2.
- K994337: Vitoss Scaffold Synthetic Cancellous Bone Void Filler, Orthovita Co. (2000) Summary page 2.

## Most influential descendants
- 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
- K062986: Medtronic Graft Delivery Syringe (2006), 37 descendants of its own

## Indications for use
CELLPLEXTMTCP Synthetic Cancellous Bone can be combined with autogenous bone marrow aspirate and/or blood and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. The CELLPLEXTMTCP Synthetic Cancellous Bone 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. The product resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K031817
Methodology: https://510kreport.com/methodology