Cleared Traditional

K072022 - VALEO PEDICLE SCREW SPINAL SYSTEM

K072022 is the FDA 510(k) clearance for VALEO PEDICLE SCREW SPINAL SYSTEM by Amedica Corp.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K072022 · Amedica Corp. · Orthopedic device
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Nov 2007
Decision
119d
Days
Class 2
Risk

K072022 is an FDA 510(k) clearance for the VALEO PEDICLE SCREW 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 Amedica Corp. (Washington, US). The FDA issued a Cleared decision on November 19, 2007 after a review of 119 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 Amedica Corp. devices

Submission Details

510(k) Number K072022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2007
Decision Date November 19, 2007
Days to Decision 119 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
3d faster than avg
Panel avg: 122d · This submission: 119d
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 662
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K072022.
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
K072840 · Endius, Inc. · Dec 2007
EXPEDIUM SPINE SYSTEM
K073126 · Depuy Spine, Inc. · Dec 2007
MANTIS SPINAL SYSTEM
K073151 · Stryker Corp. · Dec 2007
INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS)
K071921 · Innovasis, Inc. · Nov 2007
MERCURY SPINAL SYSTEM
K071914 · Spinal Elements, Inc. · Oct 2007
MODIFICATION TO TSRH SPINAL SYSTEM
K072429 · Medtronic Sofamor Danek · Sep 2007