Cleared Traditional

K031100 - SYNTHES VENTROFIX MIS SYSTEM

K031100 is an FDA 510(k) clearance for SYNTHES VENTROFIX MIS SYSTEM, manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 332-day FDA review.

K031100 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
332d
Days
Class 2
Risk

K031100 is an FDA 510(k) clearance for the SYNTHES VENTROFIX MIS SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on March 4, 2004 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K031100

510(k) Number K031100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2003
Decision Date March 04, 2004
Days to Decision 332 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
210d slower than avg
Panel avg: 122d · This submission: 332d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 586
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K031100.
MODIFICATION TO CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
K040397 · Encore Medical, L.P. · May 2004
REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM
K040261 · Stryker Spine · Apr 2004
EAGLE ANTERIOR CERVIAL PLATE SYSTEM
K040197 · Depuyacromed · Apr 2004
SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEM
K033844 · Synthes (Usa) · Feb 2004
CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
K031214 · Encore Medical, L.P. · Sep 2003
SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM
K031855 · Spinal Concepts, Inc. · Sep 2003