Cleared Special

K082195 - MODIFICATIONS TO EXPEDIUM SPINE SYSTEM

K082195 is an FDA 510(k) clearance for MODIFICATIONS TO 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.

K082195 · Depuy Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
30d
Days
Class 2
Risk

K082195 is an FDA 510(k) clearance for the MODIFICATIONS TO 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 3, 2008 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.

FDA 510(k) Submission Details - K082195

510(k) Number K082195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2008
Decision Date September 03, 2008
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
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 913
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K082195.
SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310)
K082032 · Abbott Spine, Inc. · Oct 2008
BLACKSTONE PEDICLE SCREW SYSTEM
K081684 · Blackstone Medical, Inc. · Sep 2008
EXPEDIUM SPINE SYSTEM
K081898 · Depuy Spine, Inc. · Sep 2008
MONOPOLY PEDICLE SCREW SYSTEM
K081108 · Signus Medical, LLC · Jul 2008
LAGUNA SIZE 8 PEDICLE SCREW
K072678 · Allez Spine, LLC · Jul 2008
MODIFICATION TO CORAL SPINAL SYSTEM
K081414 · Theken Spine, LLC · Jun 2008
K082195 · MODIFICATIONS TO EXPEDIUM SPINE SYSTEM
Download PDF FDA Summary Depuy Spine, Inc.