# K091692: Aesculap Peek Craniofix

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Aug 12, 2010 after 428 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: 2 generations back to K002334 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040080: Aesculap Absorbable Craniofix, Aesculap, Inc. (2004) Summary page 1.

## Indications for use
Aesculap's PEEK CranioFix is intended for fixation of cranial bone flaps.

Source page: https://510kreport.com/device/K091692
Methodology: https://510kreport.com/methodology