Cleared Traditional

K133402 - K2M MODULAR HOOKS

K133402 is the FDA 510(k) clearance for K2M MODULAR HOOKS by K2m, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K133402 · K2m, Inc. · Orthopedic device
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Jul 2014
Decision
266d
Days
Class 2
Risk

K133402 is an FDA 510(k) clearance for the K2M MODULAR HOOKS. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by K2m, Inc. (Chesterland, US). The FDA issued a Cleared decision on July 30, 2014 after a review of 266 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 K2m, Inc. devices

Submission Details

510(k) Number K133402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2013
Decision Date July 30, 2014
Days to Decision 266 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 122d · This submission: 266d
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 668
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K133402.
M.U.S.T PEDICLE SCREW SYSTEM
K141988 · Medacta International · Aug 2014
M.U.S.T. EXTENSION
K141044 · Medacta International · Aug 2014
CD HORIZON SPINAL SYSTEM
K141494 · Medtronic Sofamor Danek USA, Inc. · Aug 2014
CD HORIZON SPINAL SYSTEM
K141605 · Medtronic Sofamor Danek USA, Inc. · Jul 2014
RANGE/MESA/DENALI SPINAL SYSTEM
K140765 · K2m, Inc. · Jul 2014
RANGE SPINAL SYSTEM
K141147 · K2m, Inc. · Jun 2014