Cleared Traditional

MedCAD AccuPlan Orthopedics System

K223421 · Medcad · Orthopedic

Sep 2023

Decision

314d

Days

Class 2

Risk

About This 510(k) Submission

K223421 is an FDA 510(k) clearance for the MedCAD AccuPlan Orthopedics 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 September 20, 2023, 314 days after receiving the submission on November 10, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K223421 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 10, 2022
Decision Date	September 20, 2023
Days to Decision	314 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.