Cleared Traditional

K190044 - VSP Orthopedics System

K190044 is the FDA 510(k) clearance for VSP Orthopedics System by 3D Systems, Inc.. It is a Class 2 Orthopedic device (product code PBF) cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K190044 · 3D Systems, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2019
Decision
224d
Days
Class 2
Risk

K190044 is an FDA 510(k) clearance for the VSP Orthopedics System. Classified as Orthopaedic Surgical Planning And Instrument Guides (product code PBF), Class II - Special Controls.

Submitted by 3D Systems, Inc. (Littleton, US). The FDA issued a Cleared decision on August 21, 2019 after a review of 224 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all 3D Systems, Inc. devices

Submission Details

510(k) Number K190044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2019
Decision Date August 21, 2019
Days to Decision 224 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 122d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PBF Orthopaedic Surgical Planning And Instrument Guides
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - PBF Orthopaedic Surgical Planning And Instrument Guides

All 26
Devices cleared under the same product code (PBF) and FDA review panel - the closest regulatory comparables to K190044.
3D-Cut
K212237 · 3D-Side S.A. · Nov 2021
VSP® Orthopedics System
K211244 · 3D Systems · Nov 2021
KLS Martin Individual Patient Solutions (IPS) Planning System
K192979 · KLS-Martin L.P. · Mar 2020
SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides
K163156 · Materialise NV · Jan 2017
SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES
K132290 · Materialise NV · Apr 2014
SURGICASE CONNECT, SURGICASE GUIDE
K112389 · Materialise NV · Jul 2012