# K072432: F3 Fractured Finger Fixator, Sterile (Model: FCS 400) and Non Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Hand Biomechanics Lab, Inc.
- Decided: Jan 9, 2008 after 133 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: 1 generation back to K970713 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970713: Compass Universal Hinge, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 1.

## Most influential descendants
- K181192: PIP Fix (2018), 0 descendants of its own

## Indications for use
The F3 Fractured Finger Fixator is indicated for the treatment of acute, unstable dorsal fracture-dislocations of the proximal interphalangeal (PIP) joint of the fingers in which external skeletal fixation as provided by the F3 Fractured Finger Fixator alone is sufficient to obtain and maintain concentric reduction of the fracture-dislocation during bone and soft tissue healing.

Source page: https://510kreport.com/device/K072432
Methodology: https://510kreport.com/methodology