Cleared Traditional

K072943 - BUTREX BUTTRESS PLATING SYSTEM

K072943 is the FDA 510(k) clearance for BUTREX BUTTRESS PLATING SYSTEM by X-Spine Systems, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K072943 · X-Spine Systems, Inc. · Orthopedic device
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Jan 2008
Decision
103d
Days
Class 2
Risk

K072943 is an FDA 510(k) clearance for the BUTREX BUTTRESS PLATING SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by X-Spine Systems, Inc. (Miamisburg, US). The FDA issued a Cleared decision on January 28, 2008 after a review of 103 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 X-Spine Systems, Inc. devices

Submission Details

510(k) Number K072943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2007
Decision Date January 28, 2008
Days to Decision 103 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
19d faster than avg
Panel avg: 122d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 435
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K072943.
CAYMAN BUTTRESS PLATE SYSTEM
K080302 · K2m, Inc. · Mar 2008
THOR ANTERIOR PLATING SYSTEM
K073437 · Stryker Spine · Feb 2008
NUVASIVE HELIX MINI ACP SYSTEM
K073275 · Nuvasive, Inc. · Jan 2008
PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM
K072703 · Pioneer Surgical Technology · Jan 2008
KINETIC-SL ANTERIOR CERVICAL PLATE SYSTEM
K073479 · Life Spine · Jan 2008
SYNTHES VECTRA-ONE SYSTEM
K071667 · Synthes Spine · Nov 2007