Cleared Traditional

K250921 - CORIOGRAPH Pre-Op Planning and Modeling Services

K250921 is an FDA 510(k) clearance for CORIOGRAPH Pre-Op Planning and Modeling..., manufactured by Blue Belt Technologies, Inc.. The device is a Class 2 Orthopedic device with product code PBF cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K250921

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.

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 K250921.
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K240415 · Newclip Technics · Nov 2024