# K200587: VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder

- Pathway: 510(k) (Traditional)
- Applicant: Orthosensor, Inc.
- Decided: Aug 25, 2020 after 172 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 4.

## Indications for use
The VERASENSE for Exactech Equinoxe is for any medical condition in which reverse Total Shoulder Arthroplasty (rTSA) would be indicated. For use as a tool for measuring load magnitude and displaying center of load location of the humeral component on the glenosphere component. The device does not make a diagnosis and is not intended to replace a surgeon’s clinical judgement. The VERASENSE for Exactech Equinoxe is sterile, for single patient use.

Source page: https://510kreport.com/device/K200587
Methodology: https://510kreport.com/methodology