# K072636: A-BSM Bone Substitute Material

- Pathway: 510(k) (Special)
- Applicant: Etex Corp.
- Decided: Oct 23, 2007 after 35 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: 1 generation back to K011048 (2001). 1 ancestor in all.
26 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011048: BSM Bone Substitute Material, DePuy Orthopaedics, Inc. (2001) Summary page 1.

## Most influential descendants
- K090242: Gamma-BSM, Beta-BSM (2009), 25 descendants of its own
- K091607: Alpha-BSM, Beta-BSM, Gamma-BSM, Equivabone (2009), 22 descendants of its own
- K093447: Carrigen (2010), 21 descendants of its own
- K101557: Gamma-BSM, Beta-BSM, Equivabone, Carigen (2010), 10 descendants of its own
- K103799: Inqu Paste Mix Plus (2011), 9 descendants of its own

## Indications for use
α-BSM Bone Substitute Material is indicated for filling bone voids or defects of the skeletal system (such as the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. α-BSM Bone Substitute Material is a bone graft substitute that resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K072636
Methodology: https://510kreport.com/methodology