Cleared Special

K052123 - SYNTHES PANGEA SYSTEM

K052123 is the FDA 510(k) clearance for SYNTHES PANGEA SYSTEM by Synthes (Usa). It is a Class 2 Orthopedic device (product code KWP) cleared through the Special 510(k) pathway after a 49-day FDA review.

K052123 · Synthes (Usa) · Orthopedic device
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Sep 2005
Decision
49d
Days
Class 2
Risk

K052123 is an FDA 510(k) clearance for the SYNTHES PANGEA SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on September 23, 2005 after a review of 49 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 Synthes (Usa) devices

Submission Details

510(k) Number K052123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2005
Decision Date September 23, 2005
Days to Decision 49 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
73d faster than avg
Panel avg: 122d · This submission: 49d
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 265
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K052123.
SOLANAS POSTERIOR STABILIZATION SYSTEM
K052201 · Alphatec Spine, Inc. · Nov 2005
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
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM
K052376 · Medtronic Sofamor Danek · Sep 2005
VERTEX RECONSTRUCTION SYSTEM
K052402 · Medtronic Sofamor Danek · Sep 2005
MODIFICATION TO XIA SPINAL SYSTEM
K052181 · Stryker Spine · Sep 2005