# K974186: Orthofix External Fixation Screw (Pin) with Hydroxyapatite Coating

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Mar 18, 1998 after 131 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
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Orthofix external fixation pin (uncoated): named in the summary without a submission number

## Most influential descendants
- K132820: Vilex Ultima External Fixation System with HA Coated Pins and Wires (2014), 5 descendants of its own
- K163487: Ultima HA Coated Half Pins and Wire (2017), 4 descendants of its own
- K243798: Orthex External Fixation System (2025), 1 descendant of its own
- K202054: Dynex Ring Fixation System, Diametrix Ring Fixation System (2020), 1 descendant of its own
- K260900: DYNEX® External Fixation Systems (2026), 0 descendants of its own

## Indications for use
The Orthofix external fixation screw (pin) with hydroxyapatite coating is indicated for use in the external fixation of bone.

Source page: https://510kreport.com/device/K974186
Methodology: https://510kreport.com/methodology