# K072601: Osteosymbionics Patient Specific Cranial Implant

- Pathway: 510(k) (Traditional)
- Applicant: Osteosymbionics, LLC
- Decided: Dec 10, 2007 after 87 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: 2 generations back to K904111 (1990). 5 ancestors in all.
20 later devices descend from it; 6 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033868: Synthes (Usa) Patient Specific Cranial/Craniofacial Implants, Synthes (Usa) (2004) Summary page 1.
- K043250: Stryker Patient Specific Polymer Implant, Stryker Leibinger (2005) Summary page 1.
- K873689: Cranioplastic, Acrylic Cranioplasty Material, Dentsply Intl. (1987) Summary page 1.

## Most influential descendants
- K110684: Medcad Accushape (TM) Peek Patient Specific Cranial / Craniofacial Implant (2011), 11 descendants of its own
- K103582: Kelyniam Custom Skull Implant (Csi) (2011), 8 descendants of its own
- K133082: Osteosymbionics Patient-Specific Cranial Plate (2014), 5 descendants of its own
- K121755: Custom Craniofacial Implant (Cci) (2012), 5 descendants of its own
- K182711: Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) (2019), 4 descendants of its own

## Indications for use
The OsteoSymbionics Patient Specific Cranial Implants are designed individually for each patient to correct defects in craniofacial bone.

Source page: https://510kreport.com/device/K072601
Methodology: https://510kreport.com/methodology