Cleared Traditional

OSTAPEK VBR SYSTEM (K072326) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K072326 · Co-Ligne AG · Orthopedic device
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Jun 2008
Decision
309d
Days
Class 2
Risk

K072326 is an FDA 510(k) clearance for the OSTAPEK VBR SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Co-Ligne AG (Concord, US). The FDA issued a Cleared decision on June 24, 2008 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Co-Ligne AG devices

Submission Details

510(k) Number K072326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2007
Decision Date June 24, 2008
Days to Decision 309 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 122d · This submission: 309d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K072326.
T2 XVBR 1.5 SPINAL SYSTEM
K100976 · Medtronic Sofamor Danek USA, Inc. · Oct 2010
T2 SPINAL SYSTEM
K091883 · Medtronic Sofamor Danek USA, Inc. · Sep 2009
T2 XVBR SPINAL SYSTEM
K082112 · Medtronic Sofamor Danek · Aug 2008
NIKO CORPECTOMY SPACER
K072465 · Globus Medical, Inc. · Oct 2007
T2 XVBR SPINAL SYSTEM
K071033 · Medtronic Sofamor Danek · Aug 2007
T2 SCEPTOR SPINAL SYSTEM
K063491 · Medtronic Sofamor Danek · Mar 2007