# OSF: Patient Specific Manual Orthopedic Stereotaxic System

- Device class: 2; regulation: 21 CFR 882.4560; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 330 days (middle half 322–337)
- Recalls: 1 (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)
- 2010: 1
- 2021: 1
- 2024: 1

## Most-cited predicates
- K093491: Hip Sextant Instrument System (2010), cited by 1
- K200384: HipXpert 3D Display and Anchoring Application (2021), cited by 1

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