# K022597: K-FIX

- Pathway: 510(k) (Traditional)
- Applicant: New Deal, S.A.
- Decided: Nov 1, 2002 after 88 days
- Product code: HTY (Pin, Fixation, Smooth)
- 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 K831072 (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)
- K914812: K-Cap-E, Sterile, Westcon Orthopedics, Inc. (1992) Summary page 2.
- K831072: Jurgan Pin Ball, Jurgan Development & Mfg., Ltd. (1983) Summary page 2.

## Most influential descendants
- K203698: CoLink Sfx Implant System (2021), 1 descendant of its own
- K231905: Electro-Spec Steri-Caps (2023), 0 descendants of its own

## Indications for use
The wire protecting caps K-FIX03 are indicated for use in the protection of protruding ends of wires. Examples of protruding wires include: -Osteotomies, arthrodesis or fractures management in the foot or hand. -Fixation of small bone fragments, in long bones or small bones fractures.

Source page: https://510kreport.com/device/K022597
Methodology: https://510kreport.com/methodology