Cleared Special

K081898 - EXPEDIUM SPINE SYSTEM

K081898 is the FDA 510(k) clearance for EXPEDIUM SPINE SYSTEM by Depuy Spine, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Special 510(k) pathway after a 69-day FDA review.

K081898 · Depuy Spine, Inc. · Orthopedic device
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Sep 2008
Decision
69d
Days
Class 2
Risk

K081898 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 September 10, 2008 after a review of 69 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

Submission Details

510(k) Number K081898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2008
Decision Date September 10, 2008
Days to Decision 69 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
53d faster than avg
Panel avg: 122d · This submission: 69d
Pathway characteristics
Modification to existing cleared device.

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 614
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K081898.
NUVASIVE SPHERX SYSTEM
K082332 · Nuvasive, Inc. · Oct 2008
RADIUS SPINAL SYSTEM, VITALLIUM ROD #486613601
K082608 · Stryker Spine · Oct 2008
BLACKSTONE PEDICLE SCREW SYSTEM
K081684 · Blackstone Medical, Inc. · Sep 2008
MODIFICATIONS TO EXPEDIUM SPINE SYSTEM
K082195 · Depuy Spine, Inc. · Sep 2008
AXIS FIXATION SYSTEM
K062254 · Medtronic Sofamor Danek, Inc. · Jun 2008
EXPEDIUM 4.5MM SPINE SYSTEM
K081252 · Depuy Spine, Inc. · May 2008