# K132656: Prodense Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Mar 24, 2014 after 210 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: 3 generations back to K060011 (2006). 4 ancestors in all.
1 later device descends from it; 1 cites 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)
- K113871: Pro-Dense Bone Graft Substitute, Wrightmedicaltechnologyinc (2013)
- K072597: Pro-Dense Core Decompression Procedure Kit, Wrightmedicaltechnologyinc (2007) Summary page 1.

## Most influential descendants
- K141746: AS20 Composite Graft (2014), 0 descendants of its own

## Indications for use
PRO-DENSE 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 the result of benign bone cysts and tumors (in adults and pediatric patients 6 years old), 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 PRO-DENSE 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. PRO-DENSE is provided sterile for single use only. For the PRO-DENSE® Core Decompression Procedure Kit: The PRO-DENSE® 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 with bone during the healing process. The bone void filler included in the PRO-DENSE® Core Decompression Procedure Kit is not intended to be used as a load-bearing device.

Source page: https://510kreport.com/device/K132656
Methodology: https://510kreport.com/methodology