# K013050: The Bioplate Zip Craniotomy Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Bioplate, Inc.
- Decided: Dec 10, 2001 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: 3 generations back to K971252 (1998). 7 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 12 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.
- K991860: Synthes Cranial Flap Twist Clamp, Synthes (Usa) (1999) Summary page 1.
- K992000: Synthes Cranial Flap Tube Clamp, Synthes (Usa) (1999) Summary page 1.
- K991029: Rapidflap Cranial Clamp, Walter Lorenz Surgical, Inc. (1999) Summary page 1.
- K971252: Sevrain Cranial Clamp, Ikonos Corp. (1998) Summary page 2.
- K971408: Sevrain Cranial Clamp (SCC-200 Series), Ikonos Corp. (1998) Summary page 2.
- K972332: Aesculap Craniofix Titanium Clamp System, Aesculap, Inc. (1998) Summary page 2.

## Most influential descendants
- 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 Bioplate® ZIP™ Craniotomy Fixation System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. The device is used to align and stabilized bony tissue while normal healing occurs. Each device is intended for single use only and may be combined only with other titanium and titanium alloy implants.

Source page: https://510kreport.com/device/K013050
Methodology: https://510kreport.com/methodology