# K131130: Navigation Pin

- Pathway: 510(k) (Traditional)
- Applicant: Evergreen Orthopedic Research Lab
- Decided: Jul 19, 2013 after 87 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- 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 K002053 (2000). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100599: Cas Fixation Pin 3.2 Dia X 180 MM STR, Cas Fixaton Pin 3.2 Dia X 80 MM STR, Cas Fixaton Pin 3.2 Dia X 150 MM, Orthosoft, Inc. (2010) Summary page 1.

## Indications for use
The Operativ Navigation Pin is indicated for use as temporary fixation pin to attach an orthopedic stereotaxic tracker holder to bone which allows the tracker to be referenced by the computer during a total knee arthroplasty.

Source page: https://510kreport.com/device/K131130
Methodology: https://510kreport.com/methodology