# K993990: Leibinger Quik Disk Titanium Clamp System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Feb 22, 2000 after 90 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 K971252 (1998). 4 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 11 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 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.

## Most influential descendants
- K013050: The Bioplate Zip Craniotomy Fixation System (2001), 4 descendants of its own
- K020088: Modification of the Bioplate Zip Craniotomy Fixation System (2002), 2 descendants of its own
- K070901: Modified Plate  Design for Bioplate Zip Craniotomy Fixation System (2007), 1 descendant of its own
- K082175: Mofication to: Modified Plate Design for Bioplate Zip Craniotomy Fixation (2008), 0 descendants of its own
- K051293: Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation System (2005), 0 descendants of its own

## Indications for use
The Leibinger Quik Disk Titanium Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.

Source page: https://510kreport.com/device/K993990
Methodology: https://510kreport.com/methodology