Cleared Traditional

K072432 - F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE (FDA 510(k) Clearance)

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

K072432 · Hand Biomechanics Lab, Inc. · Orthopedic device
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Jan 2008
Decision
133d
Days
Class 2
Risk

K072432 is an FDA 510(k) clearance for the F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Hand Biomechanics Lab, Inc. (Sacramento, US). The FDA issued a Cleared decision on January 9, 2008 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Hand Biomechanics Lab, Inc. devices

Submission Details

510(k) Number K072432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2007
Decision Date January 09, 2008
Days to Decision 133 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 122d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JEC Component, Traction, Invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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.