Cleared Traditional

K070638 - THEKEN ATOLL CERVICO-THORACIC SYSTEM

K070638 is an FDA 510(k) clearance for THEKEN ATOLL CERVICO-THORACIC SYSTEM, manufactured by Theken Spine, LLC. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K070638 · Theken Spine, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
84d
Days
Class 2
Risk

K070638 is an FDA 510(k) clearance for the 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 May 30, 2007 after a review of 84 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Theken Spine, LLC devices

FDA 510(k) Submission Details - K070638

510(k) Number K070638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2007
Decision Date May 30, 2007
Days to Decision 84 days
Submission Type Traditional
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
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K070638.
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K070742 · Medtronic Sofamor Danek · Sep 2007
LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM
K070341 · Ldr Spine USA · Aug 2007
EXPEDIUM SFX CROSS CONNECTOR SYSTEM
K070300 · Depuy Spine, Inc. · Apr 2007
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K061591 · Medtronic Sofamor Danek, Inc. · Sep 2006
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K061579 · Medtronic Sofamor Danek · Aug 2006