Cleared Traditional

K242272 - CORIOGRAPH Pre-Op Planning and Modeling Services (FDA 510(k) Clearance)

K242272 · Blue Belt Technologies, Inc. · Orthopedic device
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Nov 2024
Decision
106d
Days
-
Risk

K242272 is an FDA 510(k) clearance for the CORIOGRAPH Pre-Op Planning and Modeling Services.

Submitted by Blue Belt Technologies, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on November 15, 2024 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel. 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.

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Submission Details

510(k) Number K242272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2024
Decision Date November 15, 2024
Days to Decision 106 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
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -