Cleared Traditional

K031687 - VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES

K031687 is an FDA 510(k) clearance for VANGUARD REPROCESSED EXTERNAL FIXATION ..., manufactured by Vanguard Medical Concepts, Inc.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 333-day FDA review.

K031687 · Vanguard Medical Concepts, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 2004
Decision
333d
Days
Class 2
Risk

K031687 is an FDA 510(k) clearance for the VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Vanguard Medical Concepts, Inc. (Lakeland, US). The FDA issued a Cleared decision on April 30, 2004 after a review of 333 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Vanguard Medical Concepts, Inc. devices

FDA 510(k) Submission Details - K031687

510(k) Number K031687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2003
Decision Date April 30, 2004
Days to Decision 333 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
211d slower than avg
Panel avg: 122d · This submission: 333d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTT Device Classification - Class 2, Special Controls

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 367
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K031687.
EBI XFIX DFS SYSTEM
K040935 · Ebi, L.P. · Jul 2004
OMEGA 2 SYSTEM
K041001 · Howmedica Osteonics Corp. · Jul 2004
FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES
K041081 · Hand Innovations, Inc. · Jul 2004
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
K040833 · Ebi, L.P. · Apr 2004
SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE
K040258 · Synthes (Usa) · Mar 2004
3.5 MM LCP DISTAL HUMERUS SYSTEM
K033995 · Synthes (Usa) · Mar 2004