Cleared Special

K062174 - MODIFICATION TO EXPEDIUM SPINE SYSTEM

K062174 is an FDA 510(k) clearance for MODIFICATION TO EXPEDIUM SPINE SYSTEM, manufactured by Depuy Spine, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 94-day FDA review.

K062174 · Depuy Spine, Inc. · Orthopedic device
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Nov 2006
Decision
94d
Days
Class 2
Risk

K062174 is an FDA 510(k) clearance for the MODIFICATION TO EXPEDIUM SPINE SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Depuy Spine, Inc. (Raynham, US). The FDA issued a Cleared decision on November 2, 2006 after a review of 94 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. 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. Standard predicate reliance. 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 - K062174

510(k) Number K062174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2006
Decision Date November 02, 2006
Days to Decision 94 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
28d faster than avg
Panel avg: 122d · This submission: 94d
Pathway characteristics
Modification to existing cleared device.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 236
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K062174.
RANGE SPINAL SYSTEM, LARGE DENALI SCREWS
K081381 · K2m, Inc. · Jun 2008
ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM
K071890 · Alphatec Spine, Inc. · Nov 2007
CAPLESS LI PEDICLE SCREW SYSTEM
K072282 · X-Spine Systems, Inc. · Sep 2007
ISS INTEGRATED SPINE SYSTEM
K061524 · Ortho Development Corp. · Sep 2006
MANTIS SPINAL SYSTEM
K061813 · Stryker Spine · Sep 2006
OVALTWIST PEDICLE SCREW SYSTEM
K061577 · Signus Medizintechnik GmbH · Sep 2006