Cleared Special

K002858 - XIA SPINE SYSTEM

K002858 is the FDA 510(k) clearance for XIA SPINE SYSTEM by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Special 510(k) pathway after a 30-day FDA review.

K002858 · Howmedica Osteonics Corp. · Orthopedic device
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Oct 2000
Decision
30d
Days
Class 2
Risk

K002858 is an FDA 510(k) clearance for the XIA SPINE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on October 13, 2000 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Corp. devices

Submission Details

510(k) Number K002858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2000
Decision Date October 13, 2000
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 435
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K002858.
REFLEX ANTERIOR CERVICAL PLATE SYSTEM
K010115 · Howmedica Osteonics Corp. · Apr 2001
EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM
K010003 · Ebi, L.P. · Jan 2001
MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM
K002980 · Ebi, L.P. · Oct 2000
INTERPORE CROSS ANTERIOR CERVICAL PLATE SYSTEM
K002592 · Interpore Cross Intl. · Oct 2000
K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM
K002371 · Spineology, Inc. · Sep 2000
ANTERIOR CERVICAL PLATE SYSTEM
K001847 · Encore Orthopedics, Inc. · Aug 2000