Cleared Traditional

K110046 - ATHENA PEDICLE SCREW SYSTEM (FDA 510(k) Clearance)

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

K110046 · Royal Oak Medical Devices · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
335d
Days
Class 2
Risk

K110046 is an FDA 510(k) clearance for the ATHENA PEDICLE SCREW SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Royal Oak Medical Devices (Bloomfield Hills, US). The FDA issued a Cleared decision on December 7, 2011 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Royal Oak Medical Devices devices

Submission Details

510(k) Number K110046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2011
Decision Date December 07, 2011
Days to Decision 335 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
213d slower than avg
Panel avg: 122d · This submission: 335d
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 895
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K110046.
PERLA® TL Posterior Thoraco-lumbar Fixation System
K253966 · Spineart SA · May 2026
LEO Spinal System
K252542 · ZheJiang Decans Medical Devices Co., Ltd. · Apr 2026
M.U.S.T. Pedicle Screw System - Extension
K253940 · Medacta International S.A. · Apr 2026
CD Horizon™ ModuLeX™ Fenestrated Screw Set
K260216 · Medtronic Sofamor Danek USA, Inc. · Apr 2026
ARx® SAI Implant System
K254274 · Life Spine, Inc. · Apr 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K260786 · S.M.A.I.O · Apr 2026