# K231905: Electro-Spec Steri-Caps

- Pathway: 510(k) (Traditional)
- Applicant: Electro-Spec, Inc.
- Decided: Aug 14, 2023 after 46 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: 6 generations back to K960385 (1996). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203698: CoLink Sfx Implant System, In2bones USA, LLC (2021) Summary page 4.
- K192768: Temporary Fixation Pins, Eisertech, LLC (2019) Summary page 4.

## Indications for use
Electro-Spec Steri-Caps are indicated for use in protection of protruding ends of wires. Examples of procedures that may leave protruding wires include: - Osteotomies or arthrodesis of 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/K231905
Methodology: https://510kreport.com/methodology