Cleared Traditional

K051764 - T-PLATE ANTERIOR FIXATION SYSTEM

K051764 is an FDA 510(k) clearance for T-PLATE ANTERIOR FIXATION SYSTEM, manufactured by Esm Technologies. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K051764 · Esm Technologies · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
13d
Days
Class 2
Risk

K051764 is an FDA 510(k) clearance for the T-PLATE ANTERIOR FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Esm Technologies (Madison, US). The FDA issued a Cleared decision on July 13, 2005 after a review of 13 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 Esm Technologies devices

FDA 510(k) Submission Details - K051764

510(k) Number K051764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2005
Decision Date July 13, 2005
Days to Decision 13 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 122d · This submission: 13d
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 536
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K051764.
SPIDER CERVICAL PLATING (SCP) SYSTEM
K052292 · X-Spine Systems, Inc. · Oct 2005
HYBRID ANTERIOR CERVICAL PLATE SYSTEM
K052552 · Depuy Spine, Inc. · Oct 2005
SYNTHES VECTRA-T SYSTEM
K051665 · Synthes Spine · Sep 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