# K100707: Reprocessed Pins

- Pathway: 510(k) (Special)
- Applicant: Sterilmed, Inc.
- Decided: Jun 25, 2010 after 105 days
- Product code: NDM (Pin, Fixation, Threaded, Metallic)
- 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The pins are intended to be used to rigidly fixate a Tracker to a single bone during computer assisted surgical procedures including hip, knee, and other trauma applications. Specifically: * Navigation and Ortholock Ex-Pins: The intended use of the Stryker Ortholock Ex-Pins is to rigidly fixate a Tracker to the bone undergoing treatment. The Stryker OrthoLock Ex-Pins are intended to be used with, but are not limited to, the OrthoLock system. * Anchoring Pins: The Anchoring Pins are components of the Hip, Trauma and Knee Modules of the Stryker Navigation System and intended to be used to rigidly fixate a Tracker to a single bone.

Source page: https://510kreport.com/device/K100707
Methodology: https://510kreport.com/methodology