Cleared Traditional

K063772 - EXPEDIUM SPINE SYSTEM

K063772 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 Traditional 510(k) pathway after a 201-day FDA review.

K063772 · Depuy Spine, Inc. · Orthopedic device
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Jul 2007
Decision
201d
Days
Class 2
Risk

K063772 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 July 10, 2007 after a review of 201 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 Depuy Spine, Inc. devices

Submission Details

510(k) Number K063772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2006
Decision Date July 10, 2007
Days to Decision 201 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
79d slower than avg
Panel avg: 122d · This submission: 201d
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 614
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K063772.
MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM
K071380 · Alphatec Spine, Inc. · Aug 2007
MODIFICATION TO: VIPER SPINE SYSTEM
K071860 · Depuy Spine, Inc. · Aug 2007
DEVICE MODIFICATION TO RADIUS SPINAL SYSTEM
K070631 · Stryker Spine · Jul 2007
QUANTUM SPINAL SYSTEM
K070973 · Pioneer Surgical Technology · Jul 2007
MODIFICATIONS TO CD HORIZON SPINAL SYSTEM
K063670 · Medtronic Sofamor Danek · Jun 2007
TRIO PLATE SYSTEM, TRIO SPINAL FIXATION SYSTEM, TRIO+ SPINAL SYSTEM
K070368 · Stryker Corp. · May 2007