MedCAD AccuPlan Orthopedics System
FDA 510(k) K223421 · Medcad
510(k) numberK223421
Submission
- Device name
- MedCAD AccuPlan Orthopedics System
- Applicant
- Medcad
Dallas, TX, US - Received
- November 10, 2022
- Decision date
- September 20, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PBF – Orthopaedic Surgical Planning And Instrument Guides
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
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.
Other 510(k)s with product code PBF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252064 | MedCAD® AccuStride SystemPBF · Traditional | Medcad | 03/27/2026SE |
| K250711 | VSP Orthopedics SystemPBF · Traditional | 3D Systems, Inc. | 12/05/2025SE |
| K242603 | MyPAO SA guidesPBF · Traditional | Medacta International S.A. | 11/19/2025SE |
| K251709 | MedCAD® AccuStride SystemPBF · Traditional | Medcad | 11/04/2025SE |
| K250394 | Fine TTOPBF · Traditional | Bodycad Laboratories, Inc. | 10/21/2025SE |
| K250767 | Newclip Patient-matched instrumentation non sterile PSIPBF · Traditional | Newclip Technics | 10/01/2025SE |
| K250921 | CORIOGRAPH Pre-Op Planning and Modeling ServicesPBF · Traditional | Blue Belt Technologies, Inc. | 06/25/2025SE |
| K241811 | MedCAD® AccuStride SystemPBF · Traditional | Medcad | 03/13/2025SE |
| K243912 | Newclip Patient-matched instrumentation non sterile PSIPBF · Traditional | Newclip Technics | 02/13/2025SE |
| K240415 | Newclip Patient-matched instrumentation non sterile PSIPBF · Traditional | Newclip Technics | 11/07/2024SE |
More from Newclip Technics
| 510(k) | Device | Decision |
|---|---|---|
| K252064 | MedCAD® AccuStride SystemPBF · Traditional | 03/27/2026SE |
| K251709 | MedCAD® AccuStride SystemPBF · Traditional | 11/04/2025SE |
| K241811 | MedCAD® AccuStride SystemPBF · Traditional | 03/13/2025SE |
| K230398 | MedCAD® AccuPlate® 3DTi Patient-Specific Plating SystemJEY · Traditional | 09/26/2023SE |
| K223024 | MedCAD AccuPlan SystemDZJ · Traditional | 03/07/2023SE |
| K220357 | MedCAD AccuShape Titanium Patient-Specific Cranial ImplantGXN · Traditional | 08/26/2022SE |
| K193280 | MedCAD® AccuPlate® Patient-Specific PlateJEY · Traditional | 02/12/2021SE |
| K192282 | MedCAD® AccuPlan® SystemDZJ · Traditional | 10/29/2020SE |
Questions and answers
When was MedCAD AccuPlan Orthopedics System cleared by the FDA?
MedCAD AccuPlan Orthopedics System (K223421) received a 510(k) decision of Substantially Equivalent on September 20, 2023, 314 days after the submission was received.
What is the product code of K223421?
The FDA product code is PBF – Orthopaedic Surgical Planning And Instrument Guides, a Class II (moderate risk) device regulated under 21 CFR 888.3030.