# K980370: Biosymmetric Proximal Interphalangeal Joint Fixator

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Apr 14, 1998 after 74 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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.
6 later devices descend from it; 3 cite 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)
- K970713: Compass Universal Hinge, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 1.

## Most influential descendants
- K094043: Ligamentotaxor (2010), 3 descendants of its own
- K132731: Digifix External Fixation System (2014), 1 descendant of its own
- K992970: Digit Widget (1999), 1 descendant of its own
- K192465: DigiFix Sterile Kit (2019), 0 descendants of its own
- K122415: X-Fix Dynamic External Distractor (2013), 0 descendants of its own

## Indications for use
1) Complex fracture-dislocations of the proximal Interphalangeal joint. 2) Unstable PIP dislocations 3) Post-traumatic contracture of the PIP joint

Source page: https://510kreport.com/device/K980370
Methodology: https://510kreport.com/methodology