# K031654: Synthes Resorbable Cranial Clamp, (Modified)

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Aug 8, 2003 after 72 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
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 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) Synthes Resorbable Cranial Clamp: named in the summary without a submission number
- (no number) Medtronic INVISx Lock System: named in the summary without a submission number

## Most influential descendants
- K040080: Aesculap Absorbable Craniofix (2004), 8 descendants of its own
- 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

## Indications for use
Synthes Resorbable Cranial Clamp is intended for covering burr holes and for fixation of cranial bone flaps.

Source page: https://510kreport.com/device/K031654
Methodology: https://510kreport.com/methodology