# K122353: Crainfix 2 Titanium Clamp System

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Inc.
- Decided: Aug 30, 2012 after 27 days
- Product code: GXN (Plate, Cranioplasty, Preformed, Non-Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5330
- 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 K923705 (1994). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040864: Craniofix and CRANIOFIX2 Titanium Clamp System, Aesculap (2004) Summary page 2.

## Most influential descendants
- K130447: Speedy Flap System (2014), 0 descendants of its own

## Indications for use
Aesculap's CranioFix 2 System is intended for use in the fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures.

Source page: https://510kreport.com/device/K122353
Methodology: https://510kreport.com/methodology