# K991398: Bonesource Hydroxyapatite Cement (Hac) Expanded Kit

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Leibinger
- Decided: Sep 22, 1999 after 153 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). 6 ancestors in all.
45 later devices descend from it; 2 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)
- K953339: Bonesource Hydroxyapatite Cement (Hac), Osteogenics, Inc. (1996). Our OCR of the scanned summary read K853339, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “BoneSource Hydroxyapatite Cement”.
- K964537: Bonesource Hydroxyapatite Cement (Hac), Osteogenics, Inc. (1997). Our OCR of the scanned summary read K864537, FDA’s number for 40CC Percutaneous Pre-Furl (D/L) Balloon Catheter (Aries Medical, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “BoneSource Hydroxyapatite Cement”.
- K970400: Bone Source Hydroxyapatite, Orthofix, Inc. (1997) Summary page 1.
- K973789: Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair System (CRS) Bone Cement- 10CC, Norian Corp. (1998) Summary page 1.

## Most influential descendants
- 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
- K060061: Stryker Injectable Cement (2006), 30 descendants of its own
- K161447: HydroSet XT (2016), 10 descendants of its own

## Indications for use
The BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit is indicated 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. BoneSource is also indicated for augmentation or restoration of bony contour in the craniofacial skeleton including the fronto-orbital, malar and mental areas.

Source page: https://510kreport.com/device/K991398
Methodology: https://510kreport.com/methodology