Cleared Traditional

VSP? Orthopedics System

K211244 · 3D Systems · Orthopedic

Nov 2021

Decision

198d

Days

Class 2

Risk

About This 510(k) Submission

K211244 is an FDA 510(k) clearance for the VSP? Orthopedics System, a Orthopaedic Surgical Planning And Instrument Guides (Class II — Special Controls, product code PBF), submitted by 3D Systems (Littleton, US). The FDA issued a Cleared decision on November 10, 2021, 198 days after receiving the submission on April 26, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K211244 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 26, 2021
Decision Date	November 10, 2021
Days to Decision	198 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.