# K972332: Aesculap Craniofix Titanium Clamp System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Jan 16, 1998 after 207 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
No predicates in its family tree.
81 later devices descend from it; 8 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K040864: Craniofix and CRANIOFIX2 Titanium Clamp System (2004), 67 descendants of its own
- K022277: Osteomed Cranial Flap Fixation System (2003), 63 descendants of its own
- 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

## Indications for use
Aesculap’s CRANIOFIX Titanium Clamp System is intended for use in refixation of cranial bone flaps after craniotomy.

Source page: https://510kreport.com/device/K972332
Methodology: https://510kreport.com/methodology