Cleared Special

K002505 - XIA SPINE SYSTEM

K002505 is the FDA 510(k) clearance for XIA SPINE SYSTEM by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code KWP) cleared through the Special 510(k) pathway after a 51-day FDA review.

K002505 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
51d
Days
Class 2
Risk

K002505 is an FDA 510(k) clearance for the XIA SPINE SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on October 5, 2000 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 K002505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2000
Decision Date October 05, 2000
Days to Decision 51 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
71d faster than avg
Panel avg: 122d · This submission: 51d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 271
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K002505.
SIMPLICITY SPINAL SYSTEM
K002103 · Medtronic Sofamor Danek USA, Inc. · Nov 2000
MODIFICATION TO ISOBAR SPINAL SYSTEM
K002959 · Encore Orthopedics, Inc. · Oct 2000
SPEEDLINK TRANSVERSE CONNECTOR
K002082 · Spinal Concepts, Inc. · Oct 2000
USS VAS
K002517 · Synthes (Usa) · Sep 2000
MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTION SCREWS AND SACRAL EXTENDERS
K002607 · Depuyacromed · Sep 2000
XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY
K001653 · Howmedica Osteonics Corp. · Aug 2000