# K970400: Bone Source Hydroxyapatite

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix, Inc.
- Decided: May 2, 1997 after 88 days
- Product code: LZK (Implant, Malar)
- Device class: 2
- Regulation: 21 CFR 878.3550
- 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 K922489 (1992). 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)
- K922489: Medpor Surg Implant Material:Prefor Cran/Fac Impla, Porex Technologies Corp. (1992) 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
BoneSource® Hydroxyapatite Cement (HAC) is cement indicated for the augmentation or restoration of bony contour in the craniofacial skeleton.

Source page: https://510kreport.com/device/K970400
Methodology: https://510kreport.com/methodology