Cleared Traditional

K142005 - SpineFab Vertebral Body Replacement (VB...

K142005 is an FDA 510(k) clearance for SpineFab Vertebral Body Replacement (VB..., manufactured by Oxford Performance Materials. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 352-day FDA review.

K142005 · Oxford Performance Materials · Orthopedic device
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Jul 2015
Decision
352d
Days
Class 2
Risk

K142005 is an FDA 510(k) clearance for the SpineFab Vertebral Body Replacement (VBR) System. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Oxford Performance Materials (South Windsor, US). The FDA issued a Cleared decision on July 10, 2015 after a review of 352 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 Oxford Performance Materials devices

FDA 510(k) Submission Details - K142005

510(k) Number K142005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2014
Decision Date July 10, 2015
Days to Decision 352 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
230d slower than avg
Panel avg: 122d · This submission: 352d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 201
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K142005.
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CAPRI
K142016 · K2m, Inc. · Nov 2014