Cleared Special

K050348 - CO VERTEBRAL BODY REPLACEMENT

K050348 is an FDA 510(k) clearance for CO VERTEBRAL BODY REPLACEMENT, manufactured by Scient'X. The device is a Class 2 Orthopedic device with product code MQP cleared through the Special 510(k) pathway after a 105-day FDA review.

K050348 · Scient'X · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
105d
Days
Class 2
Risk

K050348 is an FDA 510(k) clearance for the CO VERTEBRAL BODY REPLACEMENT. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Scient'X (Round Rock, US). The FDA issued a Cleared decision on May 27, 2005 after a review of 105 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. 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. Standard predicate reliance. 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 - K050348

510(k) Number K050348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2005
Decision Date May 27, 2005
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
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 278
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K050348.
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1
K051196 · Implex Corp. · Jun 2005
CONSTRUX MINI PEEK VBR SYSTEM
K051246 · Blackstone Medical, Inc. · Jun 2005
BASIS VERTEBRAL BODY SPACER
K051105 · Medtronic Sofamor Danek · Jun 2005
PEEK CAS
K050861 · Interpore Cross Intl. · May 2005
XPAND CORPECTOMY SPACER
K050850 · Globus Medical, Inc. · May 2005
FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE
K051000 · Spinal Concepts, Inc. · May 2005
K050348 · CO VERTEBRAL BODY REPLACEMENT
Download PDF FDA Summary Scient'X