Cleared Traditional

K190044 - VSP Orthopedics System

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

K190044 · 3D Systems, Inc. · Orthopedic device
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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

FDA 510(k) Submission Details - K190044

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.

PBF Device Classification - Class 2, Special Controls

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