# K041611: Synthes (Usa) Rapid Resorbable Cranial Clamp

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Sep 8, 2004 after 85 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.
5 later devices descend from it; 3 cite it directly.
0 of 6 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) Biomet Lactosorb RapidFlap: named in the summary without a submission number

## Most influential descendants
- K130309: Rapidflap LS Cranial Flap Fixation System (2013), 1 descendant of its own
- K073115: Orthomesh (2008), 1 descendant of its own
- K221606: Absorbable Cranial Flap Fixation System (2023), 0 descendants of its own
- K180821: TruMatch Graft Cage - Long Bone (2018), 0 descendants of its own
- K123633: TRS Cranial Bone Void Filler (TRS C-BVF) (2013), 0 descendants of its own

## Indications for use
Synthes Rapid Resorbable Cranial Clamp is indicated for covering burr holes and for fixation of cranial bone flaps in adult and pediatric populations.

Source page: https://510kreport.com/device/K041611
Methodology: https://510kreport.com/methodology