PBF — Orthopaedic Surgical Planning And Instrument Guides Class II
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 |
|---|---|---|---|
| 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 |
| K212237 | 3d-side | 3D-Cut | November 29, 2021 |