Cleared Traditional

K102195 - SP-FIX SPINOUS PROCESS FIXATION PLATE

K102195 is an FDA 510(k) clearance for SP-FIX SPINOUS PROCESS FIXATION PLATE, manufactured by Globus Medical, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K102195 · Globus Medical, Inc. · Orthopedic device
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Jan 2011
Decision
168d
Days
Class 2
Risk

K102195 is an FDA 510(k) clearance for the SP-FIX SPINOUS PROCESS FIXATION PLATE. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on January 19, 2011 after a review of 168 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Globus Medical, Inc. devices

FDA 510(k) Submission Details - K102195

510(k) Number K102195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2010
Decision Date January 19, 2011
Days to Decision 168 days
Submission Type Traditional
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
46d slower than avg
Panel avg: 122d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 384
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K102195.
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K110522 · Medtronic Sofamor Danek USA, Inc. · Apr 2011
PIONEER SPINAL PROCESS FUSION PLATE
K110367 · Pioneer Surgical Technology, Inc. · Mar 2011
CD HORIZON SPINAL SYSTEM
K102886 · Medtronic Sofamor Danek, Inc. · Jan 2011
CASPIAN SPINAL SYSTEM
K103232 · K2m, Inc. · Jan 2011
AXLE INTERSPINOUS FUSION SYSTEM
K101471 · X-Spine Systems, Inc. · Nov 2010
MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
K100888 · Lanx, Inc. · Nov 2010