Cleared Traditional

K100970 - STAINLESS STEEL SPINAL SYSTEM (FDA 510(k) Clearance)

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

K100970 · Theken Spine, LLC · Orthopedic device
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Aug 2010
Decision
126d
Days
Class 2
Risk

K100970 is an FDA 510(k) clearance for the STAINLESS STEEL SPINAL SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Theken Spine, LLC (Akron, US). The FDA issued a Cleared decision on August 12, 2010 after a review of 126 days - within the typical 510(k) review window.

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 Theken Spine, LLC devices

Submission Details

510(k) Number K100970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2010
Decision Date August 12, 2010
Days to Decision 126 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
4d slower than avg
Panel avg: 122d · This submission: 126d
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 K100970.
PERLA® TL Posterior Thoraco-lumbar Fixation System
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K252542 · ZheJiang Decans Medical Devices Co., Ltd. · Apr 2026
M.U.S.T. Pedicle Screw System - Extension
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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