# K021440: Bonesource Hac

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Aug 2, 2002 after 88 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: 4 generations back to K873689 (1987). 9 ancestors in all.
43 later devices descend from it; 3 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991398: Bonesource Hydroxyapatite Cement (Hac) Expanded Kit, Stryker Leibinger (1999) Summary page 2.
- K953339: Bonesource Hydroxyapatite Cement (Hac), Osteogenics, Inc. (1996) Summary page 2.
- K964537: Bonesource Hydroxyapatite Cement (Hac), Osteogenics, Inc. (1997) Summary page 2.
- K970400: Bone Source Hydroxyapatite, Orthofix, Inc. (1997) Summary page 2.
- K990290: Craniofacial Calcium Phosphate Ceramic Bone Filler, Biomet, Inc. (1999) Summary page 2.
- K012569: Modification to: Injectable Mimix, Biomet, Inc. (2001)

## Most influential descendants
- 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
- K060763: Stryker Injectable Cement (2006), 8 descendants of its own

## Indications for use
BoneSourceO is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.

Source page: https://510kreport.com/device/K021440
Methodology: https://510kreport.com/methodology