# K032307: Cap Bone Substitute Material

- Pathway: 510(k) (Traditional)
- Applicant: Etex Corp.
- Decided: Oct 24, 2003 after 91 days
- Product code: GXP (Methyl Methacrylate For Cranioplasty)
- Device class: 2
- Regulation: 21 CFR 882.5300
- 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 K873689 (1987). 3 ancestors in all.
3 later devices descend 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)
- K983009: BSM- Bone Substitute Material, Etex Corp. (1998) Summary page 1.

## Most influential descendants
- K091729: Alpha-BSM, Beta-BSM, Gamma-BSM, Equivabone (2009), 2 descendants of its own
- K100883: Carrigen (2010), 0 descendants of its own
- K102812: Gamma-BSM; Beta-BSM; Equivabone (2010), 0 descendants of its own

## Indications for use
CaP Bone Substitute Material is an implantable bone graft, that is a synthetic calcium phosphate hydroxyapatitic material intended to be implanted for use in the filling, repair, reconstruction and augmentation of burr holes, contiguous craniotomy cuts, and other defects in craniofacial bones including fronto-orbital, malar and mental areas with a surface area no larger than 25cm².

Source page: https://510kreport.com/device/K032307
Methodology: https://510kreport.com/methodology