# OLO: Orthopedic Stereotaxic Instrument

- Device class: 2; regulation: 21 CFR 882.4560; FDA's rule: 510(k) required
- FDA decisions: 444
- 510(k) review time 2021–2025: median 90 days (middle half 58–154)
- Recalls: 44 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 33
- 2018: 24
- 2019: 35
- 2020: 34
- 2021: 28
- 2022: 40
- 2023: 45
- 2024: 44
- 2025: 40
- 2026: 42

## Most-cited predicates
- K140454: Navigated CD Horizon Solera Screwdriver/Taps (2014), cited by 49
- K171651: Excelsius GPS (2017), cited by 28
- K143628: Navigated Vertex Select Instruments (2015), cited by 20
- K124004: Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps (2013), cited by 15
- K170011: StealthStation S8 Spine Software v1.0.0 (2017), cited by 11
- K150231: Navigated Disc Prep Instruments and CAPSTONE Trials (2015), cited by 11
- K153203: Navigation Instruments (2016), cited by 11
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module (2019), cited by 11
- K131425: Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter (2013), cited by 8
- K201189: Stealthstation S8 Spine Software v1.3.0 (2020), cited by 8

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