# K200665: VERASENSE for Stryker Triathlon

- Pathway: 510(k) (Special)
- Applicant: Orthosensor, Inc.
- Decided: Apr 12, 2020 after 30 days
- Product code: ONN (Intraoperative Orthopedic Joint Assessment Aid)
- 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 K070108 (2007). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180459: VERASENSE for Zimmer Biomet Persona, Orthosensor, Inc. (2018) Summary page 6.

## Indications for use
VERASENSE is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated. For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. VERASENSE is sterile, for single patient use.

Source page: https://510kreport.com/device/K200665
Methodology: https://510kreport.com/methodology