Cleared Traditional

K072407 - BODYFORM THORACIC FIXATION SYSTEM

K072407 is an FDA 510(k) clearance for BODYFORM THORACIC FIXATION SYSTEM, manufactured by Theken Spine, LLC. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K072407 · Theken Spine, LLC · Orthopedic device
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Dec 2007
Decision
116d
Days
Class 2
Risk

K072407 is an FDA 510(k) clearance for the BODYFORM THORACIC FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Theken Spine, LLC (Akron, US). The FDA issued a Cleared decision on December 21, 2007 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Theken Spine, LLC devices

FDA 510(k) Submission Details - K072407

510(k) Number K072407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2007
Decision Date December 21, 2007
Days to Decision 116 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
6d faster than avg
Panel avg: 122d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 470
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K072407.
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K073479 · Life Spine · Jan 2008
SYNTHES VECTRA-ONE SYSTEM
K071667 · Synthes Spine · Nov 2007
PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM
K071416 · Medtronic Sofamor Danek USA, Inc. · Nov 2007
NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM
K072339 · Nuvasive, Inc. · Oct 2007