Cleared Special

K012870 - XIA STAINLESS STEEL SYSTEM

K012870 is the FDA 510(k) clearance for XIA STAINLESS STEEL SYSTEM by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code KWP) cleared through the Special 510(k) pathway after a 28-day FDA review.

K012870 · Howmedica Osteonics Corp. · Orthopedic device
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Sep 2001
Decision
28d
Days
Class 2
Risk

K012870 is an FDA 510(k) clearance for the XIA STAINLESS STEEL 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 September 24, 2001 after a review of 28 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 K012870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2001
Decision Date September 24, 2001
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
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 K012870.
EBI SPINELINK - II SPINAL FIXATION SYSTEM
K012516 · Ebi, L.P. · Nov 2001
ISOLA POLYAXIAL WASHER
K013441 · Depuyacromed · Nov 2001
VERTEX RECONSTRUCTION SYSTEM
K003780 · Medtronic Sofamor Danek, Inc. · Sep 2001
SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177
K012871 · Interpore Cross Intl. · Sep 2001
TRI-FIX SPINAL FIXATION SYSTEM
K011830 · Endius, Inc. · Jul 2001
SYNTHES CERVIFIX SYSTEM
K011969 · Synthes (Usa) · Jul 2001