K250394 is an FDA 510(k) clearance for the Fine TTO™. This device is classified as a Orthopaedic Surgical Planning And Instrument Guides (Class II - Special Controls, product code PBF).
Submitted by Bodycad Laboratories, Inc. (Quebec, CA). The FDA issued a Cleared decision on October 21, 2025, 251 days after receiving the submission on February 12, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030. 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..
| 510(k) Number | K250394 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 2025 |
| Decision Date | October 21, 2025 |
| Days to Decision | 251 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PBF - Orthopaedic Surgical Planning And Instrument Guides |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |
| 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. |