Cleared Special

K070962 - CORAL PEDICLE SCREW SYSTEM

K070962 is an FDA 510(k) clearance for CORAL PEDICLE SCREW 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 139-day FDA review.

K070962 · Theken Spine, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
139d
Days
Class 2
Risk

K070962 is an FDA 510(k) clearance for the CORAL PEDICLE SCREW 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 August 22, 2007 after a review of 139 days - within the typical 510(k) review window.

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. 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 Theken Spine, LLC devices

FDA 510(k) Submission Details - K070962

510(k) Number K070962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2007
Decision Date August 22, 2007
Days to Decision 139 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
17d slower than avg
Panel avg: 122d · This submission: 139d
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 K070962.
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
K070282 · Endius, Inc. · Sep 2007
ST360 SPINAL FIXATION SYSTEM, MODEL 07.0029-7500.5600
K072183 · Zimmer Spine, Inc. · Sep 2007
STRYKER SPINE XIA III SPINAL SYSTEM
K071373 · Stryker Spine · Aug 2007
MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM
K071380 · Alphatec Spine, Inc. · Aug 2007
MODIFICATION TO: VIPER SPINE SYSTEM
K071860 · Depuy Spine, Inc. · Aug 2007
DEVICE MODIFICATION TO RADIUS SPINAL SYSTEM
K070631 · Stryker Spine · Jul 2007