Cleared Traditional

K071151 - TENSION BAND ANTERIOR SPINAL SYSTEM

K071151 is an FDA 510(k) clearance for TENSION BAND ANTERIOR SPINAL SYSTEM, manufactured by Spinal Instrumentation Simplification Systems, LLC. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K071151 · Spinal Instrumentation Simplification Systems, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
196d
Days
Class 2
Risk

K071151 is an FDA 510(k) clearance for the TENSION BAND ANTERIOR SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Spinal Instrumentation Simplification Systems, LLC (Chesterland, US). The FDA issued a Cleared decision on November 7, 2007 after a review of 196 days - an extended review cycle.

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 Spinal Instrumentation Simplification Systems, LLC devices

FDA 510(k) Submission Details - K071151

510(k) Number K071151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2007
Decision Date November 07, 2007
Days to Decision 196 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 122d · This submission: 196d
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 516
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K071151.
KINETIC-SL ANTERIOR CERVICAL PLATE SYSTEM
K073479 · Life Spine · Jan 2008
BODYFORM THORACIC FIXATION SYSTEM
K072407 · Theken Spine, LLC · Dec 2007
SYNTHES VECTRA-ONE SYSTEM
K071667 · Synthes Spine · Nov 2007
PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM
K071416 · Medtronic Sofamor Danek USA, Inc. · Nov 2007
VALEO CERVICAL PLATE SYSTEM
K071990 · Amedica Corp. · Oct 2007
NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM
K072339 · Nuvasive, Inc. · Oct 2007