# K032427: Fep Fixation System and Stylo Wrist Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Meridan Medical
- Decided: Oct 9, 2003 after 64 days
- Product code: JEC (Component, Traction, Invasive)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 K803166 (1981). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952730: Hoffmann II External Fixation System, Howmedica Corp. (1995) Summary page 1.
- K831576: Orthofix, Electro-Biology, Inc. (1983) Summary page 1.

## Most influential descendants
- K070016: Blue Shark (2007), 0 descendants of its own
- K060403: Pta (Progressive Tibial Alignment) (2006), 0 descendants of its own

## Indications for use
The FEP and Stylo external fixation systems, are modular systems with the components of: joints, bars, clamps or screws. Such components, with various assemblies, form a device indicated for reconstruction and corrections of bone segments of the human body.

Source page: https://510kreport.com/device/K032427
Methodology: https://510kreport.com/methodology