Cleared Special

K053292 - DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS

K053292 is an FDA 510(k) clearance for DAVANTIS/ANTELYS VERTEBRAL BODY REPLACE..., manufactured by Scient'X USA, Inc.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Special 510(k) pathway after a 55-day FDA review.

K053292 · Scient'X USA, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Jan 2006
Decision
55d
Days
Class 2
Risk

K053292 is an FDA 510(k) clearance for the DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Scient'X USA, Inc. (Round Rock, US). The FDA issued a Cleared decision on January 19, 2006 after a review of 55 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.

View all Scient'X USA, Inc. devices

FDA 510(k) Submission Details - K053292

510(k) Number K053292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2005
Decision Date January 19, 2006
Days to Decision 55 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 122d · This submission: 55d
Pathway characteristics
Modification to existing cleared device.

MQP Device Classification - Class 2, Special Controls

Product Code MQP Spinal Vertebral Body Replacement Device
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 - MQP Spinal Vertebral Body Replacement Device

All 213
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K053292.
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