# K040864: Craniofix and CRANIOFIX2 Titanium Clamp System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap
- Decided: Jun 17, 2004 after 76 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: 1 generation back to K923705 (1994). 2 ancestors in all.
67 later devices descend from it; 4 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972332: Aesculap Craniofix Titanium Clamp System, Aesculap, Inc. (1998) Summary page 2.
- K923705: Aesculap Craniofacial Titanium Plates and Screws, Aesculap, Inc. (1994) Summary page 2.

## Most influential descendants
- K062857: KLS Martin Quick Disc (2006), 62 descendants of its own
- K070169: KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile (2007), 61 descendants of its own
- K151983: KLS Martin LSS Plating System (2016), 45 descendants of its own
- K202889: Able Medical Devices Valkyrie Thoracic Fixation System (2021), 39 descendants of its own
- K220782: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System (2022), 36 descendants of its own

## Indications for use
Aesculap's CranioFix and CranioFix2 System are intended for use in the fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures.

Source page: https://510kreport.com/device/K040864
Methodology: https://510kreport.com/methodology