Cleared Special

K012173 - DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM

K012173 is an FDA 510(k) clearance for DEVICE MODIFICATION OF SILHOUETTE SPIND..., manufactured by Sulzer Spine-Tech. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 78-day FDA review.

K012173 · Sulzer Spine-Tech · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
78d
Days
Class 2
Risk

K012173 is an FDA 510(k) clearance for the DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Sulzer Spine-Tech (Minneapolis, US). The FDA issued a Cleared decision on September 28, 2001 after a review of 78 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.

FDA 510(k) Submission Details - K012173

510(k) Number K012173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2001
Decision Date September 28, 2001
Days to Decision 78 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
44d faster than avg
Panel avg: 122d · This submission: 78d
Pathway characteristics
Modification to existing cleared device.

KWP Device Classification - Class 2, Special Controls

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 429
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K012173.
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
XIA STAINLESS STEEL SYSTEM
K012870 · Howmedica Osteonics Corp. · 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
K012173 · DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM
Download PDF FDA Summary Sulzer Spine-Tech