# PBF: Orthopaedic Surgical Planning And Instrument Guides

- Device class: 2; regulation: 21 CFR 888.3030; FDA's rule: 510(k) required
- FDA decisions: 27
- 510(k) review time 2021–2025: median 211 days (middle half 90–314)
- Recalls: 0 (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)
- 2014: 1
- 2017: 1
- 2019: 1
- 2020: 1
- 2021: 2
- 2022: 3
- 2023: 5
- 2024: 3
- 2025: 8
- 2026: 1

## Most-cited predicates
- K190044: VSP Orthopedics System (2019), cited by 4
- K163156: SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides (2017), cited by 3
- K132290: Surgicase Orthopaedics System, Surgicase Connect, Surgicase Guides (2014), cited by 3
- K211244: VSP® Orthopedics System (2021), cited by 3
- K112389: Surgicase Connect, Surgicase Guide (2012), cited by 3
- K241811: MedCAD® AccuStride™ System (2025), cited by 2
- K240066: Fine Osteotomy™ (2024), cited by 1
- K240415: Newclip Patient-matched instrumentation non sterile PSI (2024), cited by 1
- K231314: Fine Osteotomy™ (2023), cited by 1
- K221615: Newclip Patient-matched instrumentation non sterile PSI (2023), cited by 1

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