# K992970: Digit Widget

- Pathway: 510(k) (Traditional)
- Applicant: Hand Biomechanics Lab, Inc.
- Decided: Nov 8, 1999 after 66 days
- Product code: JDW (Pin, Fixation, Threaded)
- 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 K970713 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980370: Biosymmetric Proximal Interphalangeal Joint Fixator, Biomet, Inc. (1998) Summary page 1.
- K970713: Compass Universal Hinge, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 1.

## Most influential descendants
- K020311: Clearview Wrist Fixator (2002), 0 descendants of its own

## Indications for use
The Hand Biomechanics Lab, Inc. Digit Widget is intended for the following indication: 1. PIP joint flexion contractures with an associated loss of range of motion.

Source page: https://510kreport.com/device/K992970
Methodology: https://510kreport.com/methodology