Cleared Traditional

MedCAD? AccuStride? System

K241811 · Medcad · Orthopedic

Mar 2025

Decision

265d

Days

Class 2

Risk

About This 510(k) Submission

K241811 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 March 13, 2025, 265 days after receiving the submission on June 21, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K241811 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 21, 2024
Decision Date	March 13, 2025
Days to Decision	265 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.