Cleared Special

K050451 - SYNTHES VECTRA SYSTEM

K050451 is an FDA 510(k) clearance for SYNTHES VECTRA SYSTEM, manufactured by Synthes Spine Co.Lp. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 30-day FDA review.

K050451 · Synthes Spine Co.Lp · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
30d
Days
Class 2
Risk

K050451 is an FDA 510(k) clearance for the SYNTHES VECTRA SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Synthes Spine Co.Lp (West Chester, US). The FDA issued a Cleared decision on March 24, 2005 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K050451

510(k) Number K050451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2005
Decision Date March 24, 2005
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 657
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K050451.
VERTEVIEW ANTERIOR CERVICAL PLATE SYSTEM
K050588 · Innovative Spinal Design, LLC · Apr 2005
LANX ANTERIOR CERVICAL PLATE SYSTEM
K050774 · Lanx, LLC · Apr 2005
MODIFICATION TO: SPECTRUMTM CERVICAL SPINAL SYSTEM
K050804 · Aesculap, Inc. · Apr 2005
TAMARACK ANTERIOR THORACOLUNBAR
K050390 · Alphatec/Nexmed · Mar 2005
MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM
K050117 · Medtronic Sofamor Danek · Feb 2005
OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
K042073 · Olsen Medical · Feb 2005