# K061493: Apex Pins

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Howmedica Osteonics
- Decided: Jul 7, 2006 after 37 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.
12 later devices descend from it; 7 cite it directly.
0 of 13 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 no predicate by 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
- K211112: OIC External Fixation System (2021), 1 descendant of its own
- K202054: Dynex Ring Fixation System, Diametrix Ring Fixation System (2020), 1 descendant of its own

## Indications for use
Apex® Pins are intended for use in conjunction with external fixators in children and adults. Specific indications include, but not limited to the following conditions: bone fracture fixation for open, closed and/or unstable fractures, osteotomies, arthrodeses, deformity correction including bone transport, revision procedures where other treatments or devices have been unsuccessful or bone reconstruction procedures. The pins will be available with and without hydroxylapatite (HA) coating.

Source page: https://510kreport.com/device/K061493
Methodology: https://510kreport.com/methodology