Cleared Special

K073126 - EXPEDIUM SPINE SYSTEM

K073126 is an FDA 510(k) clearance for EXPEDIUM SPINE SYSTEM, manufactured by Depuy Spine, Inc.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Special 510(k) pathway after a 30-day FDA review.

K073126 · Depuy Spine, Inc. · Orthopedic device
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Dec 2007
Decision
30d
Days
Class 2
Risk

K073126 is an FDA 510(k) clearance for the EXPEDIUM SPINE SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Depuy Spine, Inc. (Raynham, US). The FDA issued a Cleared decision on December 6, 2007 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Depuy Spine, Inc. devices

FDA 510(k) Submission Details - K073126

510(k) Number K073126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2007
Decision Date December 06, 2007
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

NKB Device Classification - Class 2, Special Controls

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 829
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K073126.
MALIBU SPINAL SYSTEM
K072605 · Seaspine, Inc. · Dec 2007
BEACON STABILIZATION SYSTEM
K073172 · Globus Medical, Inc. · Dec 2007
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
K072840 · Endius, Inc. · Dec 2007
MANTIS SPINAL SYSTEM
K073151 · Stryker Corp. · Dec 2007
VALEO PEDICLE SCREW SPINAL SYSTEM
K072022 · Amedica Corp. · Nov 2007
INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS)
K071921 · Innovasis, Inc. · Nov 2007