Cleared Traditional

K071667 - SYNTHES VECTRA-ONE SYSTEM

K071667 is an FDA 510(k) clearance for SYNTHES VECTRA-ONE SYSTEM, manufactured by Synthes Spine. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K071667 · Synthes Spine · Orthopedic device
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Nov 2007
Decision
164d
Days
Class 2
Risk

K071667 is an FDA 510(k) clearance for the SYNTHES VECTRA-ONE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Synthes Spine (West Chester, US). The FDA issued a Cleared decision on November 30, 2007 after a review of 164 days - an extended review cycle.

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. 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 Synthes Spine devices

FDA 510(k) Submission Details - K071667

510(k) Number K071667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2007
Decision Date November 30, 2007
Days to Decision 164 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
42d slower than avg
Panel avg: 122d · This submission: 164d
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 623
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K071667.
POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
K071905 · Lanx, LLC · Dec 2007
THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE)
K072231 · Esm Technologies, LLC · Dec 2007
BODYFORM THORACIC FIXATION SYSTEM
K072407 · Theken Spine, LLC · Dec 2007
IST ANTERIOR CERVICAL PLATE SYSTEM
K072650 · Innovative Spinal Technologies, Inc. · Nov 2007
TENSION BAND ANTERIOR SPINAL SYSTEM
K071151 · Spinal Instrumentation Simplification Systems, LLC · Nov 2007
PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM
K071416 · Medtronic Sofamor Danek USA, Inc. · Nov 2007