Fine TTO
FDA 510(k) K250394 · Bodycad Laboratories, Inc.
510(k) numberK250394
Submission
- Device name
- Fine TTO
- Applicant
- Bodycad Laboratories, Inc.
Quebec, CA - Received
- February 12, 2025
- Decision date
- October 21, 2025
- 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.
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|---|---|---|---|
| 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 |
| 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 |
| K240113 | CORIOGRAPH Knee Pre-Op PlanPBF · Traditional | Smith & Nephew, Inc. | 03/18/2024SE |
More from Smith & Nephew, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253300 | Fine OsteotomyHRS · Special | 10/28/2025SE |
| K250923 | Fine OsteotomyHRS · Traditional | 08/21/2025SE |
| K241356 | Fine OsteotomyHRS · Traditional | 09/05/2024SE |
| K240703 | Fine OsteotomyHRS · Special | 04/12/2024SE |
| K240066 | Fine OsteotomyPBF · Special | 02/09/2024SE |
| K231314 | Fine OsteotomyPBF · Special | 06/02/2023SE |
| K212307 | BC Reflex Uni Knee SystemHSX · Traditional | 10/12/2021SE |
| K211895 | BC Reflex Uni Knee SystemHSX · Traditional | 08/20/2021SE |
| K211646 | FINE OsteotomyHRS · Traditional | 07/28/2021SE |
| K203697 | BC Reflex Uni Knee SystemHSX · Special | 03/12/2021SE |
Questions and answers
When was Fine TTO cleared by the FDA?
Fine TTO (K250394) received a 510(k) decision of Substantially Equivalent on October 21, 2025, 251 days after the submission was received.
What is the product code of K250394?
The FDA product code is PBF – Orthopaedic Surgical Planning And Instrument Guides, a Class II (moderate risk) device regulated under 21 CFR 888.3030.