# K101835: Medpor Fixation System-Cranial, Models 80080, 80079

- Pathway: 510(k) (Traditional)
- Applicant: Porex Surgical, Inc.
- Decided: Dec 3, 2010 after 155 days
- Product code: HBW (Fastener, Plate, Cranioplasty)
- Device class: 2
- Regulation: 21 CFR 882.5360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K904436 (1990). 85 ancestors in all.
No later device cites it as a predicate yet.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073006: Osteotrans -MX Bioabsorbable Bone Fixation System, Takiron Co., Ltd. (2008) Summary page 1.
- K022012: Synthes Low Profile Neuro System, Synthes (Usa) (2002) Summary page 1.
- K021642: Synthes Craniofacial Plates, Synthes (Usa) (2002) Summary page 1.
- K963546: SMF Titanium (TI) Alloy Bone Screws, Synthes (Usa) (1997) Summary page 1.
- K031659: Universal Neuro System, Stryker Instruments (2003) Summary page 1.

## Indications for use
The MEDPOR Fixation System - Cranial is intended for use in cranial surgery to fixate MEDPOR cranial implants to the surrounding cranial skeleton.

Source page: https://510kreport.com/device/K101835
Methodology: https://510kreport.com/methodology