# K061599: Pin Screw

- Pathway: 510(k) (Traditional)
- Applicant: Bk Meditech, Co., Ltd.
- Decided: Jul 26, 2006 after 48 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
Longest line of descent: 1 generation back to K011136 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011136: Apex Fixation Pins, Howmedica Osteonics Corp. (2001) Summary page 1.

## Indications for use
The Pins are intended to be used in conjunction with a rigid external supporting frame for immobilization of open and/of unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.

Source page: https://510kreport.com/device/K061599
Methodology: https://510kreport.com/methodology