# K981716: External Fixation

- Pathway: 510(k) (Traditional)
- Applicant: Avanta Orthopaedics, Inc.
- Decided: Jul 17, 1998 after 63 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 K831576 (1983). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974911: External Fixator, Avanta Orthopaedics, Inc. (1998) Summary page 1.
- K831576: Orthofix, Electro-Biology, Inc. (1983) Summary page 1.

## Most influential descendants
- K101375: Trimed X-Fix (2010), 1 descendant of its own
- K122208: External Fixator System (2012), 0 descendants of its own

## Indications for use
The intended use of the external fixation device is the same as that expressed in the predicate device 510k. The intended use of the external fixator is unilateral external fixation, device which is intended for use in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis. fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.

Source page: https://510kreport.com/device/K981716
Methodology: https://510kreport.com/methodology