Cleared Special

K081414 - MODIFICATION TO CORAL SPINAL SYSTEM

K081414 is an FDA 510(k) clearance for MODIFICATION TO CORAL SPINAL SYSTEM, manufactured by Theken Spine, LLC. The device is a Class 2 Orthopedic device with product code NKB cleared through the Special 510(k) pathway after a 28-day FDA review.

K081414 · Theken Spine, LLC · Orthopedic device
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Jun 2008
Decision
28d
Days
Class 2
Risk

K081414 is an FDA 510(k) clearance for the MODIFICATION TO CORAL SPINAL SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Theken Spine, LLC (Akron, US). The FDA issued a Cleared decision on June 17, 2008 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 - K081414

510(k) Number K081414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2008
Decision Date June 17, 2008
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

NKB Device Classification - Class 2, Special Controls

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 706
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K081414.
BLACKSTONE PEDICLE SCREW SYSTEM
K081684 · Blackstone Medical, Inc. · Sep 2008
EXPEDIUM SPINE SYSTEM
K081898 · Depuy Spine, Inc. · Sep 2008
MODIFICATIONS TO EXPEDIUM SPINE SYSTEM
K082195 · Depuy Spine, Inc. · Sep 2008
AXIS FIXATION SYSTEM
K062254 · Medtronic Sofamor Danek, Inc. · Jun 2008
EXPEDIUM 4.5MM SPINE SYSTEM
K081252 · Depuy Spine, Inc. · May 2008
REVERE UNIPLANAR SCREWS
K081195 · Globus Medical, Inc. · May 2008