# K130498: Osteoselect Demineralized Bone Matrix Putty

- Pathway: 510(k) (Traditional)
- Applicant: Bacterin International, Inc.
- Decided: May 31, 2013 after 94 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K040262 (2005). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
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 1.
- K103784: DBX Demineralized Bone Matrix Putty, Musculoskeletal Transplant Foundation (2011) Summary page 1.
- K103795: DBX Demineralized Bone Matrix Putty, Musculoskeletal Transplant Foundation (2011) Summary page 1.

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

## Recalls of this device
- May 3, 2019 · Class II · Z-1526-2020: The firm received one customer complaint concerning three OsteoSelect Demineralized Bone Matrix (DBM) devices which contained 5.0cc of putty, instead of 10.00cc of putty as labeled.

## Indications for use
OsteoSelect® DBMV 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 strtucture. OsteoSelect® OBM 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: a Extremities * Posterolateral spine * Pelvis

Source page: https://510kreport.com/device/K130498
Methodology: https://510kreport.com/methodology