# K082463: Progenix

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Nov 10, 2008 after 75 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: 8 generations back to K963562 (1997). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080462: Progenix DBM Putty, Medtronic Sofamor Danek (2008) Summary page 1.
- K081950: Progenix Plus, Medtronic Sofamor Danek, Inc. (2008) Summary page 1.
- K051188: Grafton DBM, Osteotech, Inc. (2006) Summary page 2.

## Indications for use
PROGENIX® DBM Putty and PROGENIX® Plus may be used alone or in combination with autograft bone and/or autogenous bone marrow for use as a bone graft extender, substitute, and bone void filler in bony voids or gaps, not intrinsic to the stability of the bony structure, of the cranial, oral and maxillofacial region. The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PROGENIX® DBM Putty and PROGENIX® Plus provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. PROGENIX® DBM Putty and PROGENIX® Plus are intended to be used alone or in combination with autogenous bone and/ or bone marrow aspirate for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of cranial oral maxillofacial 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/K082463
Methodology: https://510kreport.com/methodology