PBF — Orthopaedic Surgical Planning And Instrument Guides Class II
FDA product code PBF covers "Orthopaedic Surgical Planning And Instrument Guides", a Class II medical device regulated under 21 CFR 888.3030. Submissions are reviewed by the Orthopedic panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PBF
- Device Class
- Class II
- Regulation Number
- 888.3030
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252064 | medcad | MedCAD® AccuStride System | March 27, 2026 |
| K250711 | 3d systems | VSP Orthopedics System | December 5, 2025 |
| K242603 | medacta international | MyPAO SA guides | November 19, 2025 |
| K251709 | medcad | MedCAD® AccuStride System | November 4, 2025 |
| K250394 | bodycad laboratories | Fine TTO | October 21, 2025 |
| K250767 | newclip technics | Newclip Patient-matched instrumentation non sterile PSI | October 1, 2025 |
| K250921 | blue belt technologies | CORIOGRAPH Pre-Op Planning and Modeling Services | June 25, 2025 |
| K241811 | medcad | MedCAD® AccuStride System | March 13, 2025 |
| K243912 | newclip technics | Newclip Patient-matched instrumentation non sterile PSI | February 13, 2025 |
| K240415 | newclip technics | Newclip Patient-matched instrumentation non sterile PSI | November 7, 2024 |
| K240113 | smith and nephew | CORIOGRAPH Knee Pre-Op Plan | March 18, 2024 |
| K240066 | bodycad laboratories | Fine Osteotomy | February 9, 2024 |
| K221615 | newclip technics | Newclip Patient-matched instrumentation non sterile PSI | October 25, 2023 |
| K223421 | medcad | MedCAD AccuPlan Orthopedics System | September 20, 2023 |
| K231314 | bodycad laboratories | Fine Osteotomy | June 2, 2023 |
| K220706 | medacta international | MyPAO Guides | May 30, 2023 |
| K221943 | 3d lifeprints uk | EmbedMed | February 1, 2023 |
| K211614 | centermed | CenterMed Patient Matched Assisted Surgical Planning (ASP) System | August 4, 2022 |
| K211076 | additive orthopaedics | Patient Specific Marking Guides | June 28, 2022 |
| K220717 | redpoint medical | RedPoint Medical's Better Bunion System | June 9, 2022 |