Cleared Special

K022160 - XIA SPINAL SYSTEM

K022160 is an FDA 510(k) clearance for XIA SPINAL SYSTEM, manufactured by Howmedica Osteonics. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 29-day FDA review.

K022160 · Howmedica Osteonics · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
29d
Days
Class 2
Risk

K022160 is an FDA 510(k) clearance for the XIA SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Howmedica Osteonics (Allendale, US). The FDA issued a Cleared decision on August 1, 2002 after a review of 29 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 - K022160

510(k) Number K022160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2002
Decision Date August 01, 2002
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle 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 - MNI Orthosis, Spinal Pedicle Fixation

All 302
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K022160.
MODIFICATION TO TSRH SPINAL SYSTEM
K022778 · Medtronic Sofamor Danek, Inc. · Sep 2002
MODIFICATION TO ISOLA SPINAL SYSTEM
K022285 · Depuyacromed · Aug 2002
UNI-T UNI-THREAD SPINAL SYSTEM
K021510 · Spine Vision, Inc. · Aug 2002
MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
K022190 · Depuyacromed · Jul 2002
MICOMED POSTERIOR DOUBLEROD SYSTEM
K021275 · Micomed Ortho GmbH · Jul 2002
FOREX CORPORATION, OPTIMA, SPINAL SYSTEM
K020279 · Forex Corp. · Jun 2002
K022160 · XIA SPINAL SYSTEM
Download PDF FDA Summary Howmedica Osteonics