# K992000: Synthes Cranial Flap Tube Clamp

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jul 20, 1999 after 35 days
- Product code: GXN (Plate, Cranioplasty, Preformed, Non-Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5330
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 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 its predicate without a number.
- (no number) Aesculap's Craniofix Titanium Clamp System: named in the summary without a submission number

## 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
- K192702: DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional (2020), 0 descendants of its own
- K082175: Mofication to: Modified Plate Design for Bioplate Zip Craniotomy Fixation (2008), 0 descendants of its own

## Recalls of this device
- Aug 31, 2015 · Class II · Z-2811-2015: The Synthes Cranial Flap Tube Clamp and Crimping Device for Cranial Tube Clamp had been labeled MR Safe although they do not have the testing protocols currently required to designate them as MR Safe.

## Indications for use
Synthes Cranial Flap Tube Clamp is intended to reattach a cranial bone flap to the surrounding Cranium after a craniotomy procedure.

Source page: https://510kreport.com/device/K992000
Methodology: https://510kreport.com/methodology