Cleared Traditional

K032427 - FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM

K032427 is an FDA 510(k) clearance for FEP FIXATION SYSTEM AND STYLO WRIST FIX..., manufactured by Meridan Medical. The device is a Class 2 Orthopedic device with product code JEC cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K032427 · Meridan Medical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
64d
Days
Class 2
Risk

K032427 is an FDA 510(k) clearance for the FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Meridan Medical (Irvine, US). The FDA issued a Cleared decision on October 9, 2003 after a review of 64 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Meridan Medical devices

FDA 510(k) Submission Details - K032427

510(k) Number K032427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2003
Decision Date October 09, 2003
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEC Device Classification - Class 2, Special Controls

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.

Regulatory Peers - JEC Component, Traction, Invasive

All 53
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K032427.
HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX
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