Cleared Special

K012027 - MODIFICATION TO XIA SPINE SYSTEM

K012027 is an FDA 510(k) clearance for MODIFICATION TO XIA SPINE SYSTEM, manufactured by Howmedica Osteonics. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 22-day FDA review.

K012027 · Howmedica Osteonics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
22d
Days
Class 2
Risk

K012027 is an FDA 510(k) clearance for the MODIFICATION TO XIA SPINE SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Howmedica Osteonics (Allendale, US). The FDA issued a Cleared decision on July 20, 2001 after a review of 22 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 Howmedica Osteonics devices

FDA 510(k) Submission Details - K012027

510(k) Number K012027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2001
Decision Date July 20, 2001
Days to Decision 22 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
100d faster than avg
Panel avg: 122d · This submission: 22d
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 194
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K012027.
MOSS MIAMI SPINAL SYSTEMS
K013296 · Depuyacromed · Oct 2001
ISOLA SPINAL SYSTEMS
K012971 · Depuyacromed · Oct 2001
SPIRAL RADIUS 90-D SST SYSTEM
K012273 · United States Surgical, A Division of Tyco Healthc · Aug 2001
SCS CLOSED SCREW
K003733 · Ortho Tec, LLC · May 2001
MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS
K011182 · Depuyacromed · May 2001
CLARIS PLATE SYSTEM
K010369 · Ortho Tec, LLC · May 2001