Cleared Special

PEEK CAS (K050861) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K050861 · Interpore Cross Intl. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
52d
Days
Class 2
Risk

K050861 is an FDA 510(k) clearance for the PEEK CAS. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Interpore Cross Intl. (Irvine, US). The FDA issued a Cleared decision on May 27, 2005 after a review of 52 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 Interpore Cross Intl. devices

Submission Details

510(k) Number K050861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2005
Decision Date May 27, 2005
Days to Decision 52 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
70d faster than avg
Panel avg: 122d · This submission: 52d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 68
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K050861.
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K052931 · Medtronic Sofamor Danek · Nov 2005
MODIFICATION TO: VERTE-STACK SPINAL SYSTEM
K052261 · Medtronic Sofamor Danek USA, Inc. · Oct 2005
BASIS VERTEBRAL BODY SPACER
K051105 · Medtronic Sofamor Danek · Jun 2005
XPAND CORPECTOMY SPACER
K050850 · Globus Medical, Inc. · May 2005
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K043566 · Medtronic Sofamor Danek · Jan 2005
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K043561 · Medtronic Sofamor Danek · Dec 2004