Cleared Special

K080790 - MODIFICATION TO THEKEN ATOLL CERVICO-TH...

K080790 is an FDA 510(k) clearance for MODIFICATION TO THEKEN ATOLL CERVICO-TH..., manufactured by Theken Spine, LLC. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 40-day FDA review.

K080790 · Theken Spine, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
40d
Days
Class 2
Risk

K080790 is an FDA 510(k) clearance for the MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Theken Spine, LLC (Akron, US). The FDA issued a Cleared decision on April 29, 2008 after a review of 40 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 Theken Spine, LLC devices

FDA 510(k) Submission Details - K080790

510(k) Number K080790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2008
Decision Date April 29, 2008
Days to Decision 40 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
82d faster than avg
Panel avg: 122d · This submission: 40d
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 309
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K080790.
VERTEX RECONSTRUCTION SYSTEM
K083071 · Medtronic Sofamor Danek · Nov 2008
CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS
K081107 · K2m, Inc. · Oct 2008
VERTEX RECONSTRUCTION SYSTEM
K081297 · Medtronic Sofamor Danek · Jun 2008
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K080805 · Medtronic Sofamor Danek · Apr 2008
SIERRA
K072729 · Seaspine, Inc. · Apr 2008
SIERRA SYSTEM
K080526 · Seaspine, Inc. · Apr 2008