Cleared Traditional

ANY PLUS SPINAL FIXATION SYSTEM (K091717) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K091717 · GS Medical Co., Ltd. · Orthopedic device
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Jan 2010
Decision
228d
Days
Class 2
Risk

K091717 is an FDA 510(k) clearance for the ANY PLUS SPINAL FIXATION SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by GS Medical Co., Ltd. (Claremont, US). The FDA issued a Cleared decision on January 25, 2010 after a review of 228 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 GS Medical Co., Ltd. devices

Submission Details

510(k) Number K091717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2009
Decision Date January 25, 2010
Days to Decision 228 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
106d slower than avg
Panel avg: 122d · This submission: 228d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 448
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K091717.
TSRH SPINAL SYSTEM
K091797 · Medtronic Sofamor Danek · Apr 2010
SYNTHES MATRIX MIS RODS
K093668 · Synthes (Usa) · Mar 2010
REVERE STABILIZATION SYSTEM
K093294 · Globus Medical, Inc. · Feb 2010
SYNTHES MATRIX SYSTEM
K092929 · Synthes (Usa) · Dec 2009
MODIFICATION TO:CD HORIZON SPINAL SYSTEM
K092325 · Medtronic Sofamor Danek USA, Inc. · Dec 2009
VERTEX RECONSTRUCTION SYSTEM AND VERTEX SELECT RECONSTRUCTION SYSTEM
K093434 · Medtronic Sofamor Danek · Dec 2009