Product code PBF
- Device name
- Orthopaedic Surgical Planning And Instrument Guides
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3030
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252064 | MedCAD® AccuStride™ System | Medcad | 2026-03-27 |
| K250711 | VSP Orthopedics System | 3D Systems, Inc. | 2025-12-05 |
| K242603 | MyPAO SA guides | Medacta International S.A. | 2025-11-19 |
| K251709 | MedCAD® AccuStride™ System | Medcad | 2025-11-04 |
| K250394 | Fine TTO™ | Bodycad Laboratories, Inc. | 2025-10-21 |
| K250767 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2025-10-01 |
| K250921 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | 2025-06-25 |
| K241811 | MedCAD® AccuStride™ System | Medcad | 2025-03-13 |
| K243912 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2025-02-13 |
| K240415 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2024-11-07 |
| K240113 | CORIOGRAPH Knee Pre-Op Plan | Smith & Nephew, Inc. | 2024-03-18 |
| K240066 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2024-02-09 |
| K221615 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2023-10-25 |
| K223421 | MedCAD AccuPlan Orthopedics System | Medcad | 2023-09-20 |
| K231314 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2023-06-02 |
| K220706 | MyPAO Guides | Medacta International S.A. | 2023-05-30 |
| K221943 | EmbedMed | 3D Lifeprints UK , Ltd. | 2023-02-01 |
| K211614 | CenterMed Patient Matched Assisted Surgical Planning (ASP) System | Centermed, Inc. | 2022-08-04 |
| K211076 | Patient Specific Marking Guides | Additive Orthopaedics, LLC | 2022-06-28 |
| K220717 | RedPoint Medical's Better Bunion System | Redpoint Medical, LLC | 2022-06-09 |
| K212237 | 3D-Cut | 3D-Side S.A. | 2021-11-29 |
| K211244 | VSP® Orthopedics System | 3D Systems | 2021-11-10 |
| K192979 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2020-03-11 |
| K190044 | VSP Orthopedics System | 3D Systems, Inc. | 2019-08-21 |
| K163156 | SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides | Materialise NV | 2017-01-18 |
| K132290 | SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES | Materialise NV | 2014-04-10 |
| K112389 | SURGICASE CONNECT, SURGICASE GUIDE | Materialise NV | 2012-07-20 |
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| 07630345797070 | NextAR Spine Platform | Medacta International SA | 2023-07-24 |
| 07630345797063 | NextAR Spine Platform | Medacta International SA | 2023-07-24 |
| 07630345779939 | NextAR Spine Platform | Medacta International SA | 2023-07-24 |
| G2710300240140 | Intelliguides | Mios Marketing, LLC | 2023-01-01 |
| G2710205100060 | The Better Bunion | Mios Marketing, LLC | 2022-11-01 |
| G2710204120080 | The Better Bunion | Mios Marketing, LLC | 2022-11-01 |
| G2710204120060 | The Better Bunion | Mios Marketing, LLC | 2022-11-01 |
| G2710205100080 | The Better Bunion | Mios Marketing, LLC | 2022-11-01 |
| G2710205100100 | The Better Bunion | Mios Marketing, LLC | 2022-11-01 |
| G2710205110100 | The Better Bunion | Mios Marketing, LLC | 2022-11-01 |
| G2710110000160 | The Better Bunion | Mios Marketing, LLC | 2022-11-01 |
| G2710204110080 | The Better Bunion | Mios Marketing, LLC | 2022-11-01 |
| G2710204100080 | The Better Bunion | Mios Marketing, LLC | 2022-11-01 |
| G2710204100060 | The Better Bunion | Mios Marketing, LLC | 2022-11-01 |
| G2710110000260 | The Better Bunion | Mios Marketing, LLC | 2022-11-01 |
| G2710110000210 | The Better Bunion | Mios Marketing, LLC | 2022-11-01 |
| G2710110000170 | The Better Bunion | Mios Marketing, LLC | 2022-11-01 |
| G2710110000110 | The Better Bunion | Mios Marketing, LLC | 2022-11-01 |
| G2710110000080 | The Better Bunion | Mios Marketing, LLC | 2022-11-01 |
| G2710110000060 | The Better Bunion | Mios Marketing, LLC | 2022-11-01 |
| G2710123260230 | The Better Bunion | Mios Marketing, LLC | 2022-07-25 |
| 07630345731647 | NextAR Knee Platform | Medacta International SA | 2022-03-14 |
| 07630345731807 | NextAR Knee Platform | Medacta International SA | 2022-03-14 |
| 07630345731791 | NextAR Knee Platform | Medacta International SA | 2022-03-14 |
| 07630345731784 | NextAR Knee Platform | Medacta International SA | 2022-03-14 |
| 07630345731777 | NextAR Knee Platform | Medacta International SA | 2022-03-14 |
| 07630345731678 | NextAR Knee Platform | Medacta International SA | 2022-03-14 |
| 07630345731661 | NextAR Knee Platform | Medacta International SA | 2022-03-14 |
| 07630345731654 | NextAR Knee Platform | Medacta International SA | 2022-03-14 |