# K873689: Cranioplastic, Acrylic Cranioplasty Material

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Oct 26, 1987 after 45 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
No predicates in its family tree.
92 later devices descend from it; 10 cite it directly.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K953339: Bonesource Hydroxyapatite Cement (Hac) (1996), 55 descendants of its own
- K964537: Bonesource Hydroxyapatite Cement (Hac) (1997), 50 descendants of its own
- 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

Source page: https://510kreport.com/device/K873689
Methodology: https://510kreport.com/methodology