Cleared Traditional

K250921 - CORIOGRAPH Pre-Op Planning and Modeling Services (FDA 510(k) Clearance)

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

K250921 · Blue Belt Technologies, Inc. · Orthopedic device
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Jun 2025
Decision
90d
Days
Class 2
Risk

K250921 is an FDA 510(k) clearance for the CORIOGRAPH Pre-Op Planning and Modeling Services. Classified as Orthopaedic Surgical Planning And Instrument Guides (product code PBF), Class II - Special Controls.

Submitted by Blue Belt Technologies, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on June 25, 2025 after a review of 90 days - within the typical 510(k) review window.

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 Blue Belt Technologies, Inc. devices

Submission Details

510(k) Number K250921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2025
Decision Date June 25, 2025
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 K250921.
MedCAD® AccuStride™ System
K252064 · Medcad · Mar 2026
VSP Orthopedics System
K250711 · 3D Systems, Inc. · Dec 2025
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