# K091321: Osteoselect Demineralized Bone Matrix Putty

- Pathway: 510(k) (Traditional)
- Applicant: Bacterin International, Inc.
- Decided: Sep 11, 2009 after 129 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K040262 (2005). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 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 1.
- K051195: Grafton DBM, Osteotech, Inc. (2005) Summary page 1.

## Most influential descendants
- K130498: Osteoselect Demineralized Bone Matrix Putty (2013), 1 descendant of its own
- K150621: OsteoSelect PLUS Demineralized Bone Matrix Putty (2015), 0 descendants of its own

## Recalls of this device
- Feb 21, 2013 · Class II · Z-1138-2013: The firm's retesting procedure was not validated.
- Apr 18, 2012 · Class II · Z-0800-2013: Expired product was shipped to two customers.

## Indications for use
OsteoSelectTM (DBM) Putty is indicated for use as a bone'void filler and bone graft substitute for voids or gaps in the extremities and pelvis that are not intrinsic to the stability of bony structure. It is indicated for treatment of surgically created Osseous defects or osseous defects from traumatic injury to the bone.

Source page: https://510kreport.com/device/K091321
Methodology: https://510kreport.com/methodology