Cleared Special

K090565 - ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM

K090565 is an FDA 510(k) clearance for ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL..., manufactured by Globus Medical, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 120-day FDA review.

K090565 · Globus Medical, Inc. · Orthopedic device
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Jun 2009
Decision
120d
Days
Class 2
Risk

K090565 is an FDA 510(k) clearance for the ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM. 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 June 30, 2009 after a review of 120 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Globus Medical, Inc. devices

FDA 510(k) Submission Details - K090565

510(k) Number K090565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2009
Decision Date June 30, 2009
Days to Decision 120 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
2d faster than avg
Panel avg: 122d · This submission: 120d
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 384
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K090565.
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
K092656 · Lanx, Inc. · Nov 2009
SENTINEL SPINAL SYSTEM
K090343 · Life Spine · Aug 2009
SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM
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SYNTHES SYNAPSE TRANSCONNECTOR
K090549 · Synthes Spine · May 2009
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K090714 · Medtronic Sofamor Danek · Apr 2009
MODIFICATION TO: LANX SPINAL FIXATION SYSTEM
K090252 · Lanx, Inc. · Mar 2009