# K150621: OsteoSelect PLUS Demineralized Bone Matrix Putty

- Pathway: 510(k) (Traditional)
- Applicant: Bacterin International, Inc.
- Decided: Aug 18, 2015 after 160 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: 3 generations back to K040262 (2005). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091321: Osteoselect Demineralized Bone Matrix Putty, Bacterin International, Inc. (2009) Summary page 5.
- K130498: Osteoselect Demineralized Bone Matrix Putty, Bacterin International, Inc. (2013) Summary page 5.

## Indications for use
OsteoSelect® (DBM) Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoSelect® (DBM) Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect® (DBM) Putty can be used as follows: * Extremities * Posterolateral spine * Pelvis

Source page: https://510kreport.com/device/K150621
Methodology: https://510kreport.com/methodology