# K080462: Progenix DBM Putty

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: May 13, 2008 after 83 days
- Product code: NUN (Bone Grafting Material, Human Source)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K963562 (1997). 32 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072265: Progenix DMB Putty, Medtronic Sofamor Danek (2008) Summary page 2.
- K060794: Progenix DBM Putty and Paste, Medtronic Sofamor Danek (2006) Summary page 2.
- K040501: DBX Demineralized Bone Matrix Putty, Paste and Mix, Musculoskeletal Transplant Foundation (2005) Summary page 2.
- K060306: Accell Connexus Demineralized Bone Matrix Putty, Isotis NV (2006) Summary page 2.
- K070147: Intergro Oral, Biomet 3i (2007) Summary page 2.
- K051188: Grafton DBM, Osteotech, Inc. (2006) Summary page 2.

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

## Indications for use
PROGENIX TM DBM Putty is intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oralmaxillofacial and dental intraosseous defects including but not limited to: Ridge augmentation Filling of cystic defect Filling of extraction sites Filling of lesions of periodontal origin Craniofacial augmentation Filling of defects of endodontic origin Mandibular reconstruction Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall.

Source page: https://510kreport.com/device/K080462
Methodology: https://510kreport.com/methodology