Cleared Traditional

VSP® Orthopedics System (K211244) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211244 · 3D Systems · Orthopedic device
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Nov 2021
Decision
198d
Days
Class 2
Risk

K211244 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 (Littleton, US). The FDA issued a Cleared decision on November 10, 2021 after a review of 198 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 devices

Submission Details

510(k) Number K211244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 122d · This submission: 198d
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 23
Devices cleared under the same product code (PBF) and FDA review panel - the closest regulatory comparables to K211244.
Patient Specific Marking Guides
K211076 · Additive Orthopaedics, LLC · Jun 2022
RedPoint Medical's Better Bunion System
K220717 · Redpoint Medical, LLC · Jun 2022
3D-Cut
K212237 · 3D-Side S.A. · Nov 2021
KLS Martin Individual Patient Solutions (IPS) Planning System
K192979 · KLS-Martin L.P. · Mar 2020
VSP Orthopedics System
K190044 · 3D Systems, Inc. · Aug 2019