# K221606: Absorbable Cranial Flap Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Chendu Medart Medical Scientific Co., Ltd.
- Decided: Nov 21, 2023 after 537 days
- Product code: GXR (Cover, Burr Hole)
- Device class: 2
- Regulation: 21 CFR 882.5250
- 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 K002334 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130309: Rapidflap LS Cranial Flap Fixation System, Biomet Microfixation (2013) Summary page 5.

## Indications for use
The Absorbable Cranial Flap Fixation System is intended to be used for fixation of cranial bone flaps following craniotomy.

Source page: https://510kreport.com/device/K221606
Methodology: https://510kreport.com/methodology