Cleared Traditional

K051665 - SYNTHES VECTRA-T SYSTEM

K051665 is the FDA 510(k) clearance for SYNTHES VECTRA-T SYSTEM by Synthes Spine. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K051665 · Synthes Spine · Orthopedic device
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Sep 2005
Decision
79d
Days
Class 2
Risk

K051665 is an FDA 510(k) clearance for the SYNTHES VECTRA-T 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 September 9, 2005 after a review of 79 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. 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 Synthes Spine devices

Submission Details

510(k) Number K051665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2005
Decision Date September 09, 2005
Days to Decision 79 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
43d faster than avg
Panel avg: 122d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 448
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K051665.
PACP SYSTEM
K053053 · Pioneer Surgical Technology · Nov 2005
SPIDER CERVICAL PLATING (SCP) SYSTEM
K052292 · X-Spine Systems, Inc. · Oct 2005
HYBRID ANTERIOR CERVICAL PLATE SYSTEM
K052552 · Depuy Spine, Inc. · Oct 2005
BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM
K043548 · Blackstone Medical, Inc. · Jun 2005
BASIS SPINAL SYSTEM
K051039 · Medtronic Sofamor Danek USA, Inc. · May 2005
HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM
K050892 · Blackstone Medical, Inc. · May 2005