Cleared Traditional

CORIOGRAPH Knee Pre-Op Plan

K240113 · Smith & Nephew, Inc. · Orthopedic

Mar 2024

Decision

62d

Days

Class 2

Risk

About This 510(k) Submission

K240113 is an FDA 510(k) clearance for the CORIOGRAPH Knee Pre-Op Plan, a Orthopaedic Surgical Planning And Instrument Guides (Class II — Special Controls, product code PBF), submitted by Smith & Nephew, Inc. (Memphus, US). The FDA issued a Cleared decision on March 18, 2024, 62 days after receiving the submission on January 16, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K240113 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 16, 2024
Decision Date	March 18, 2024
Days to Decision	62 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.