# K040080: Aesculap Absorbable Craniofix

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Mar 31, 2004 after 76 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: 1 generation back to K002334 (2001). 3 ancestors in all.
8 later devices descend from it; 3 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)
- K031654: Synthes Resorbable Cranial Clamp, (Modified), Synthes (Usa) (2003) Summary page 1.
- K021408: Resorbable Cranial Clamps, Synthes (Usa) (2002)
- K002334: Macroporens Craniloc, Macropore Biosurgery, Inc. (2001) Summary page 1.

## Most influential descendants
- K101235: Cranial Loop Cranial Bone Fixation System (2010), 4 descendants of its own
- K132044: Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation System (2013), 3 descendants of its own
- K160739: Cranial COVER (2016), 1 descendant of its own
- K130309: Rapidflap LS Cranial Flap Fixation System (2013), 1 descendant of its own
- K240137: Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K040080
Methodology: https://510kreport.com/methodology