# K971453: Orthotec K-Cap System

- Pathway: 510(k) (Traditional)
- Applicant: Orthotech
- Decided: Jun 24, 1997 after 64 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 K831005 (1983). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K831005: Wire & Steinman Pins, Kirschner Medical Corp. (1983) Summary page 1.
- K833952: Fixation Pins, ETHICON, Inc. (1984) Summary page 1.

## Indications for use
The OrthoTec K-Cap System is intended to provide fixation of bone fragments or for bone reconstruction, while providing protection to neighboring tissues.

Source page: https://510kreport.com/device/K971453
Methodology: https://510kreport.com/methodology