Cleared Traditional

K250711 - VSP Orthopedics System

K250711 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 270-day FDA review.

K250711 · 3D Systems, Inc. · Orthopedic device
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Dec 2025
Decision
270d
Days
Class 2
Risk

K250711 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 December 5, 2025 after a review of 270 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 - K250711

510(k) Number K250711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2025
Decision Date December 05, 2025
Days to Decision 270 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
148d slower than avg
Panel avg: 122d · This submission: 270d
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 K250711.
MedCAD® AccuStride™ System
K252064 · Medcad · Mar 2026
MyPAO SA guides
K242603 · Medacta International S.A. · Nov 2025
MedCAD® AccuStride™ System
K251709 · Medcad · Nov 2025
Fine TTO™
K250394 · Bodycad Laboratories, Inc. · Oct 2025
Newclip Patient-matched instrumentation non sterile PSI
K250767 · Newclip Technics · Oct 2025
CORIOGRAPH Pre-Op Planning and Modeling Services
K250921 · Blue Belt Technologies, Inc. · Jun 2025