Cleared Traditional

MedCAD? AccuStride? System

K251709 · Medcad · Orthopedic

Nov 2025

Decision

154d

Days

Class 2

Risk

About This 510(k) Submission

K251709 is an FDA 510(k) clearance for the MedCAD? AccuStride? System, a Orthopaedic Surgical Planning And Instrument Guides (Class II — Special Controls, product code PBF), submitted by Medcad (Dallas, US). The FDA issued a Cleared decision on November 4, 2025, 154 days after receiving the submission on June 3, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K251709 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 03, 2025
Decision Date	November 04, 2025
Days to Decision	154 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.