# K072597: Pro-Dense Core Decompression Procedure Kit

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Oct 15, 2007 after 31 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 K060011 (2006). 2 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070437: Pro-Dense Bone Void Filler, Wrightmedicaltechnologyinc (2007) Summary page 1.

## Most influential descendants
- 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
- K190283: PROSTIM Injectable Inductive Graft (2019), 2 descendants of its own
- K223915: Tactoset (2023), 1 descendant of its own

## Indications for use
The PRO-DENSETM 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-DENSETM Core Decompression Procedure Kit is not intended to be used as a load-bearing device.

Source page: https://510kreport.com/device/K072597
Methodology: https://510kreport.com/methodology