PBF · Orthopaedic Surgical Planning And Instrument Guides
Orthopedic · 21 CFR 888.3030 · Class 2
Overview
| Product Code | PBF |
|---|---|
| Device Name | Orthopaedic Surgical Planning And Instrument Guides |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
Identification
Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
Classification Rationale
Class II.
Cleared Devices (27)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252064 | MedCAD® AccuStride System | Medcad | Mar 27, 2026 | SESE |
| K250711 | VSP Orthopedics System | 3D Systems, Inc. | Dec 5, 2025 | SESE |
| K242603 | MyPAO SA guides | Medacta International S.A. | Nov 19, 2025 | SESE |
| K251709 | MedCAD® AccuStride System | Medcad | Nov 4, 2025 | SESE |
| K250394 | Fine TTO | Bodycad Laboratories, Inc. | Oct 21, 2025 | SESE |
| K250767 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | Oct 1, 2025 | SESE |
| K250921 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | Jun 25, 2025 | SESE |
| K241811 | MedCAD® AccuStride System | Medcad | Mar 13, 2025 | SESE |
| K243912 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | Feb 13, 2025 | SESE |
| K240415 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | Nov 7, 2024 | SESE |
| K240113 | CORIOGRAPH Knee Pre-Op Plan | Smith & Nephew, Inc. | Mar 18, 2024 | SESE |
| K240066 | Fine Osteotomy | Bodycad Laboratories, Inc. | Feb 9, 2024 | SESE |
| K221615 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | Oct 25, 2023 | SESE |
| K223421 | MedCAD AccuPlan Orthopedics System | Medcad | Sep 20, 2023 | SESE |
| K231314 | Fine Osteotomy | Bodycad Laboratories, Inc. | Jun 2, 2023 | SESE |
| K220706 | MyPAO Guides | Medacta International S.A. | May 30, 2023 | SESE |
| K221943 | EmbedMed | 3D Lifeprints UK , Ltd. | Feb 1, 2023 | SESE |
| K211614 | CenterMed Patient Matched Assisted Surgical Planning (ASP) System | Centermed, Inc. | Aug 4, 2022 | SESE |
| K211076 | Patient Specific Marking Guides | Additive Orthopaedics, LLC | Jun 28, 2022 | SESE |
| K220717 | RedPoint Medical's Better Bunion System | Redpoint Medical, LLC | Jun 9, 2022 | SESE |
| K212237 | 3D-Cut | 3D-Side S.A. | Nov 29, 2021 | SESE |
| K211244 | VSP® Orthopedics System | 3D Systems | Nov 10, 2021 | SESE |
| K192979 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | Mar 11, 2020 | SESE |
| K190044 | VSP Orthopedics System | 3D Systems, Inc. | Aug 21, 2019 | SESE |
| K163156 | SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides | Materialise NV | Jan 18, 2017 | SESE |
| K132290 | SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES | Materialise NV | Apr 10, 2014 | SESE |
| K112389 | SURGICASE CONNECT, SURGICASE GUIDE | Materialise NV | Jul 20, 2012 | SESE |
Top Applicants
- Newclip Technics — 4 clearances
- Medcad — 4 clearances
- Materialise NV — 3 clearances
- Bodycad Laboratories, Inc. — 3 clearances
- Medacta International S.A. — 2 clearances
