Cleared Traditional

SP-FIX SPINOUS PROCESS FIXATION PLATE (K102195) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 72
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K102195.
VERTEX RECONSTRUCTION SYSTEM
K123568 · Medtronic Sofamor Danek USA, Inc. · Dec 2012
ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM
K110963 · Globus Medical, Inc. · May 2011
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K110522 · Medtronic Sofamor Danek USA, Inc. · Apr 2011
SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM
K091689 · Synthes (Usa) · Jul 2009
ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM
K090565 · Globus Medical, Inc. · Jun 2009
VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K082728 · Medtronic Sofamor Danek USA, Inc. · Jan 2009