# K072265: Progenix DMB Putty

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Jan 9, 2008 after 147 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: 5 generations back to K963562 (1997). 22 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060794: Progenix DBM Putty and Paste, Medtronic Sofamor Danek (2006) Summary page 2.
- K050690: Connexus, Isotis Orthobiologics, Inc. (2005) Summary page 2.
- K071206: Actifuse Abx E-Z-Fil Putty Bone Graft Substitute, Apatech, Ltd. (2007) Summary page 2.
- K040262: DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix Mix, Musculoskeletal Transplant Foundation (2005) Summary page 2.
- K041168: Allomatrix Putty, Wrightmedicaltechnologyinc (2004) Summary page 2.

## Most influential descendants
- K080462: Progenix DBM Putty (2008), 2 descendants of its own
- K081950: Progenix Plus (2008), 1 descendant of its own
- K082002: Progenix Plus (2008), 0 descendants of its own
- K082463: Progenix (2008), 0 descendants of its own

## Indications for use
PROGENIXTMDBM Putty is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure (i.e. spine, pelvis and extremities). The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PROGENIXTM DBM Putty provides a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. When used in the extremeties or pelvis, the device is used by itself. When used in the spine, the device must be mixed with autograft bone and used as a bone graft extender.

Source page: https://510kreport.com/device/K072265
Methodology: https://510kreport.com/methodology