# K030378: Stryker Leibinger Cranial Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Mar 20, 2003 after 43 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: 3 generations back to K971252 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993990: Leibinger Quik Disk Titanium Clamp System, Stryker Instruments (2000) Summary page 1.
- K972332: Aesculap Craniofix Titanium Clamp System, Aesculap, Inc. (1998) Summary page 1.
- K991860: Synthes Cranial Flap Twist Clamp, Synthes (Usa) (1999) Summary page 1.
- K991029: Rapidflap Cranial Clamp, Walter Lorenz Surgical, Inc. (1999) Summary page 1.

## Indications for use
The Stryker Leibinger Cranial Fixation System is intended for the fixation of a cranial bone flap after a craniotomy. The implant could be applied in the craniotomy gap as well as in burr holes.

Source page: https://510kreport.com/device/K030378
Methodology: https://510kreport.com/methodology