PBF
- Product code
- PBF
- Device name
- Orthopaedic Surgical Planning And Instrument Guides
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3030
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 27
FDA classification definition
As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.
510(k) clearances, last 3 years (14)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252064 | 2026-03-27 | Medcad | MedCAD® AccuStride System | |
| K250711 | 2025-12-05 | 3D Systems, Inc. | VSP Orthopedics System | |
| K242603 | 2025-11-19 | Medacta International S.A. | MyPAO SA guides | |
| K251709 | 2025-11-04 | Medcad | MedCAD® AccuStride System | |
| K250394 | 2025-10-21 | Bodycad Laboratories, Inc. | Fine TTO | |
| K250767 | 2025-10-01 | Newclip Technics | Newclip Patient-matched instrumentation non sterile | |
| K250921 | 2025-06-25 | Blue Belt Technologies, Inc. | CORIOGRAPH Pre-Op Planning and Modeling Services | |
| K241811 | 2025-03-13 | Medcad | MedCAD® AccuStride System | |
| K243912 | 2025-02-13 | Newclip Technics | Newclip Patient-matched instrumentation non sterile | |
| K240415 | 2024-11-07 | Newclip Technics | Newclip Patient-matched instrumentation non sterile | |
| K240113 | 2024-03-18 | Smith & Nephew, Inc. | CORIOGRAPH Knee Pre-Op Plan | |
| K240066 | 2024-02-09 | Bodycad Laboratories, Inc. | Fine Osteotomy | |
| K221615 | 2023-10-25 | Newclip Technics | Newclip Patient-matched instrumentation non sterile | FDA |
| K223421 | 2023-09-20 | Medcad | MedCAD AccuPlan Orthopedics System |
Official FDA classification page: PBF
Classification and pathway per current FDA publications. Data from openFDA (CC0).