Cleared Traditional

K052201 - SOLANAS POSTERIOR STABILIZATION SYSTEM

K052201 is the FDA 510(k) clearance for SOLANAS POSTERIOR STABILIZATION SYSTEM by Alphatec Spine, Inc.. It is a Class 2 Orthopedic device (product code KWP) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K052201 · Alphatec Spine, Inc. · Orthopedic device
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Nov 2005
Decision
90d
Days
Class 2
Risk

K052201 is an FDA 510(k) clearance for the SOLANAS POSTERIOR STABILIZATION SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 10, 2005 after a review of 90 days - within the typical 510(k) review window.

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 Alphatec Spine, Inc. devices

Submission Details

510(k) Number K052201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2005
Decision Date November 10, 2005
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 272
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K052201.
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K061579 · Medtronic Sofamor Danek · Aug 2006
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
K060683 · Endius, Inc. · Apr 2006
BASIS SPINAL SYSTEM
K060081 · Medtronic Sofamor Danek · Feb 2006
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM
K052734 · Medtronic Sofamor Danek · Oct 2005
EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS
K052131 · Depuy Spine, Inc. · Sep 2005
SYNTHES PANGEA SYSTEM
K052123 · Synthes (Usa) · Sep 2005