# K964537: Bonesource Hydroxyapatite Cement (Hac)

- Pathway: 510(k) (Traditional)
- Applicant: Osteogenics, Inc.
- Decided: Jan 24, 1997 after 73 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: 1 generation back to K873689 (1987). 1 ancestor in all.
50 later devices descend from it; 3 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K873689: Cranioplastic, Acrylic Cranioplasty Material, Dentsply Intl. (1987) Summary page 1.

## Most influential descendants
- K973789: Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair System (CRS) Bone Cement- 10CC (1998), 49 descendants of its own
- K991398: Bonesource Hydroxyapatite Cement (Hac) Expanded Kit (1999), 45 descendants of its own
- K021440: Bonesource Hac (2002), 43 descendants of its own
- K032366: Bonesource Hac Fast Setting Cement (2003), 41 descendants of its own
- K043334: Bone Source Hac Rapid Setting Cement (2005), 36 descendants of its own

## Indications for use
The Osteogenics BoneSource® Hydroxyapatite Cement (HAC) is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface area no larger than 25cm’ per defect.

Source page: https://510kreport.com/device/K964537
Methodology: https://510kreport.com/methodology