# K032366: Bonesource Hac Fast Setting Cement

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Oct 30, 2003 after 90 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: 5 generations back to K873689 (1987). 11 ancestors in all.
41 later devices descend from it; 2 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)
- K021440: Bonesource Hac, Stryker Instruments (2002) Summary page 2.
- K023718: Quickset Mimix Bone Void Filler, Walter Lorenz Surgical, Inc. (2002)

## Most influential descendants
- 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
- K173008: SCS 17-01 (2017), 4 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/K032366
Methodology: https://510kreport.com/methodology