Cleared Special

K063158 - SYNTHES ANTEGRA SYSTEM

K063158 is an FDA 510(k) clearance for SYNTHES ANTEGRA SYSTEM, manufactured by Synthes Spine Co.Lp. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 28-day FDA review.

K063158 · Synthes Spine Co.Lp · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
28d
Days
Class 2
Risk

K063158 is an FDA 510(k) clearance for the SYNTHES ANTEGRA SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Synthes Spine Co.Lp (West Chester, US). The FDA issued a Cleared decision on November 14, 2006 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K063158

510(k) Number K063158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2006
Decision Date November 14, 2006
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 657
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K063158.
PREVIEW ANTERIOR CERVICAL PLATE SYSTEM
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KINETIC ANTERIOR CERVICAL PLATE
K062643 · Life Spine · Nov 2006
MAXIMA ANTERIOR CERVICAL PLATE SYSTEM
K061002 · U&I Corp. · Nov 2006
MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM
K062831 · Life Spine · Oct 2006
UNIVERSAL SPINAL ANTERIOR LOCKING PLATE SYSTEM
K062686 · Advanced Spine Technology, Inc. · Oct 2006
GATEWAY THORACOLUMBAR PLATE SYSTEM
K062407 · Globus Medical, Inc. · Sep 2006