# K130447: Speedy Flap System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Dec 22, 2014 after 669 days
- Product code: GXN (Plate, Cranioplasty, Preformed, Non-Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K923705 (1994). 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)
- K040864: Craniofix and CRANIOFIX2 Titanium Clamp System, Aesculap (2004) Summary page 5.
- K122353: Crainfix 2 Titanium Clamp System, Aesculap, Inc. (2012) Summary page 5.

## Indications for use
Speedy Flap System is intended for use in the fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures.

Source page: https://510kreport.com/device/K130447
Methodology: https://510kreport.com/methodology