# Orthosensor, Inc.

- Location (FDA's records): Dania Beach, FL
- FDA decisions: 8 (2009–2020): 8 510(k) clearances
- Product codes: ONN (8)
- 510(k) review time since 2016: median 100 days, against 100 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 10 (8 its own); citations of its devices by later devices: 13 (8 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Orthalign, Inc.: 1 (https://510kreport.com/company/orthalign)
- Synvasive Technology, Inc.: 1 (https://510kreport.com/company/synvasive-technology)

## Firms that cite its devices most
- These Three Medical, LLC: 2 (https://510kreport.com/company/these-three-medical)
- Omnllife Science, Inc.: 1 (https://510kreport.com/company/omnllife-science)
- Eventum Orthopaedics, Ltd.: 1 (https://510kreport.com/company/eventum-orthopaedics)
- Orthalign, Inc.: 1 (https://510kreport.com/company/orthalign)

## Its most-cited devices
- K180459: VERASENSE for Zimmer Biomet Persona (2018), cited by 4
- K150372: VERASENSE Knee System (2016), cited by 3
- K130380: Orthosensor Knee Balancer (2013), cited by 2
- K090474: Orthorex Intra-Operative Load Sensor (2009), cited by 2
- K193580: VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left (2020), cited by 1
- K131767: Orthosensor Knee Balancer, Verasense Knee System (2013), cited by 1

## Recent decisions
- 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 (Aug 25, 2020)
- K200665: VERASENSE for Stryker Triathlon (Apr 12, 2020)
- K193580: VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left (Apr 1, 2020)
- K180459: VERASENSE for Zimmer Biomet Persona (Jun 7, 2018)
- K150372: VERASENSE Knee System (Apr 15, 2016)
- K131767: Orthosensor Knee Balancer, Verasense Knee System (Nov 8, 2013)
- K130380: Orthosensor Knee Balancer (Jun 13, 2013)
- K090474: Orthorex Intra-Operative Load Sensor (Oct 19, 2009)

Source page: https://510kreport.com/company/orthosensor