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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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 308
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K062174.
CAPLESS LI PEDICLE SCREW SYSTEM
K072282 · X-Spine Systems, Inc. · Sep 2007
LOWTOP PEDICLE SCREW SYSTEM
K070933 · Sanacor · Jun 2007
VERTIFLEX SPINAL SCREW SYSTEM
K062670 · Vertiflex (Tm), Incorporated · Jan 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
K062174 · MODIFICATION TO EXPEDIUM SPINE SYSTEM
Download PDF FDA Summary Depuy Spine, Inc.