# K070437: Pro-Dense Bone Void Filler

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: May 9, 2007 after 83 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 K060011 (2006). 1 ancestor in all.
15 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060011: Miig SR, Wrightmedicaltechnologyinc (2006) Summary page 2.

## Most influential descendants
- K113871: Pro-Dense Bone Graft Substitute (2013), 11 descendants of its own
- K072597: Pro-Dense Core Decompression Procedure Kit (2007), 10 descendants of its own
- K181255: PRODENSE Bone Graft Substitute (2018), 7 descendants of its own
- K182823: PRODENSE Bone Graft Substitute (2018), 5 descendants of its own
- K212083: Tactoset Injectable Bone Substitute (2021), 2 descendants of its own

## Indications for use
PRO-DENSETM 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, spine, 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 PRO-DENSETM 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-DENSM .TMis provided sterile for single use only.

Source page: https://510kreport.com/device/K070437
Methodology: https://510kreport.com/methodology