# ONN: Intraoperative Orthopedic Joint Assessment Aid

- Device class: 2; regulation: 21 CFR 882.4560; FDA's rule: 510(k) required
- FDA decisions: 18
- 510(k) review time 2021–2025: median 90 days (middle half 30–156)
- Recalls: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2013: 2
- 2014: 1
- 2016: 1
- 2017: 1
- 2018: 1
- 2020: 3
- 2022: 1
- 2024: 2
- 2025: 1
- 2026: 2

## Most-cited predicates
- K180459: VERASENSE for Zimmer Biomet Persona (2018), cited by 4
- K150372: VERASENSE Knee System (2016), cited by 3
- K070108: Elibra Dynamic Knee Balancer (2007), cited by 3
- K090474: Orthorex Intra-Operative Load Sensor (2009), cited by 2
- K130380: Orthosensor Knee Balancer (2013), cited by 2
- K242616: Lantern® Hip (2024), cited by 1
- K241298: Quadsense (2024), cited by 1
- K131767: Orthosensor Knee Balancer, Verasense Knee System (2013), cited by 1
- K132104: Elibra Soft-Tissue Force Sensor (2014), cited by 1
- 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

Source page: https://510kreport.com/product-code/ONN
Data by year (CSV): https://510kreport.com/product-code/ONN.csv