# K130309: Rapidflap LS Cranial Flap Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Microfixation
- Decided: Jun 17, 2013 after 130 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). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003281: Lactosorb Rapidflap, Biomet, Inc. (2001) Summary page 2.
- K021408: Resorbable Cranial Clamps, Synthes (Usa) (2002) Summary page 2.
- K040080: Aesculap Absorbable Craniofix, Aesculap, Inc. (2004) Summary page 2.
- K041611: Synthes (Usa) Rapid Resorbable Cranial Clamp, Synthes (Usa) (2004) Summary page 2.

## Most influential descendants
- K221606: Absorbable Cranial Flap Fixation System (2023), 0 descendants of its own

## Indications for use
The RapidFlap™ LS Cranial Flap Fixation System is indicated for use in rigid fixation of a craniotomy in adult and pediatric populations.

Source page: https://510kreport.com/device/K130309
Methodology: https://510kreport.com/methodology