Cleared Traditional

Fine TTO?

K250394 · Bodycad Laboratories, Inc. · Orthopedic

Oct 2025

Decision

251d

Days

Class 2

Risk

About This 510(k) Submission

K250394 is an FDA 510(k) clearance for the Fine TTO?, 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 review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K250394 FDA.gov
FDA Decision	Cleared 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

Device Classification

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.