Panels › Orthopedic › Product code PBF · Class 2
Orthopaedic Surgical Planning And Instrument Guides
Regulation 888.3030
3510(k)s in 12 months (27 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PBF
| Company | 510(k)s | Recalls |
|---|---|---|
| Medcad | 4 | 0 |
| Newclip Technics | 4 | 0 |
| 3D Systems | 3 | 0 |
| Bodycad Laboratories, Inc. | 3 | 0 |
| Materialise NV | 3 | 0 |
| Medacta International S.A. | 2 | 0 |
| 3D Lifeprints UK , Ltd. | 1 | 0 |
| 3D-Side S.A. | 1 | 0 |
| Additive Orthopaedics, LLC | 1 | 0 |
| Blue Belt Technologies, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 27, 2026 | K252064 | MedCAD® AccuStride System Medcad | PBF |
| Dec 5, 2025 | K250711 | VSP Orthopedics System 3D Systems, Inc. | PBF |
| Nov 19, 2025 | K242603 | MyPAO SA guides Medacta International S.A., CH | PBF |
| Nov 4, 2025 | K251709 | MedCAD® AccuStride System Medcad | PBF |
| Oct 21, 2025 | K250394 | Fine TTO Bodycad Laboratories, Inc., CA | PBF |
| Oct 1, 2025 | K250767 | Newclip Patient-matched instrumentation non sterile PSI Newclip Technics, FR | PBF |
| Jun 25, 2025 | K250921 | CORIOGRAPH Pre-Op Planning and Modeling Services Blue Belt Technologies, Inc. | PBF |
| Mar 13, 2025 | K241811 | MedCAD® AccuStride System Medcad | PBF |
| Feb 13, 2025 | K243912 | Newclip Patient-matched instrumentation non sterile PSI Newclip Technics, FR | PBF |
| Nov 7, 2024 | K240415 | Newclip Patient-matched instrumentation non sterile PSI Newclip Technics, FR | PBF |
| Mar 18, 2024 | K240113 | CORIOGRAPH Knee Pre-Op Plan Smith & Nephew, Inc. | PBF |
| Feb 9, 2024 | K240066 | Fine Osteotomy Bodycad Laboratories, Inc., CA | PBF |
| Oct 25, 2023 | K221615 | Newclip Patient-matched instrumentation non sterile PSI Newclip Technics, FR | PBF |
| Sep 20, 2023 | K223421 | MedCAD AccuPlan Orthopedics System Medcad | PBF |
| Jun 2, 2023 | K231314 | Fine Osteotomy Bodycad Laboratories, Inc., CA | PBF |
| May 30, 2023 | K220706 | MyPAO Guides Medacta International S.A., CH | PBF |
| Feb 1, 2023 | K221943 | EmbedMed 3D Lifeprints UK , Ltd., GB | PBF |
| Aug 4, 2022 | K211614 | CenterMed Patient Matched Assisted Surgical Planning (ASP) System Centermed, Inc. | PBF |
| Jun 28, 2022 | K211076 | Patient Specific Marking Guides Additive Orthopaedics, LLC | PBF |
| Jun 9, 2022 | K220717 | RedPoint Medical's Better Bunion System Redpoint Medical, LLC | PBF |
| Nov 29, 2021 | K212237 | 3D-Cut 3D-Side S.A., BE | PBF |
| Nov 10, 2021 | K211244 | VSP® Orthopedics System 3D Systems | PBF |
| Mar 11, 2020 | K192979 | KLS Martin Individual Patient Solutions (IPS) Planning System KLS-Martin L.P. | PBF |
| Aug 21, 2019 | K190044 | VSP Orthopedics System 3D Systems, Inc. | PBF |
| Jan 18, 2017 | K163156 | SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides Materialise NV, BE | PBF |
| Apr 10, 2014 | K132290 | SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES Materialise NV, BE | PBF |
| Jul 20, 2012 | K112389 | SURGICASE CONNECT, SURGICASE GUIDE Materialise NV, BE | PBF |
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