# K060794: Progenix DBM Putty and Paste

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Dec 18, 2006 after 270 days
- Product code: MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor))
- 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: 4 generations back to K963562 (1997). 10 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K043048: Grafton Plus DBM Paste, Osteotech, Inc. (2005). Our reading of the summary gave K040348, FDA’s number for Modification to HNC-127-Int Neurovascular Array Coil (Mri Devices Corp.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “GRAFTON PLUS® DBM Paste”.
- K043420: Osteofil, Optefil, Regenafil, Rti Allograft Paste, Regeneration Technologies, Inc. (2005) Summary page 2.

## Most influential descendants
- K072265: Progenix DMB Putty (2008), 4 descendants of its own
- K132868: Carricell (2015), 3 descendants of its own
- K163621: Vitoss Bioactive (BA) Injectable (2017), 2 descendants of its own
- K080462: Progenix DBM Putty (2008), 2 descendants of its own
- K242797: OsteoFlo HydroFiber (2024), 1 descendant of its own

## Indications for use
PROGENIXTM DBM Putty is intended for use as a bone graft substitute, and bone void filler in bony voids or gaps of the pelvis, ilium and extremities not intrinsic to the stability of the bony structure. 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.

Source page: https://510kreport.com/device/K060794
Methodology: https://510kreport.com/methodology