Cleared Traditional

K091359 - GSO PCT SPINAL SYSTEM

K091359 is an FDA 510(k) clearance for GSO PCT SPINAL SYSTEM, manufactured by Gold Standard Orthopaedics, LLC. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K091359 · Gold Standard Orthopaedics, LLC · Orthopedic device
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Sep 2009
Decision
117d
Days
Class 2
Risk

K091359 is an FDA 510(k) clearance for the GSO PCT SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Gold Standard Orthopaedics, LLC (Louisville, US). The FDA issued a Cleared decision on September 2, 2009 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Gold Standard Orthopaedics, LLC devices

FDA 510(k) Submission Details - K091359

510(k) Number K091359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2009
Decision Date September 02, 2009
Days to Decision 117 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
5d faster than avg
Panel avg: 122d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 338
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K091359.
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LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
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SENTINEL SPINAL SYSTEM
K090343 · Life Spine · Aug 2009
SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM
K091689 · Synthes (Usa) · Jul 2009
ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM
K090565 · Globus Medical, Inc. · Jun 2009