Cleared Traditional

K072029 - PHENIX VERTEBRAL BODY REPLACEMENT

K072029 is an FDA 510(k) clearance for PHENIX VERTEBRAL BODY REPLACEMENT, manufactured by New Business Development, LLC. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K072029 · New Business Development, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
83d
Days
Class 2
Risk

K072029 is an FDA 510(k) clearance for the PHENIX VERTEBRAL BODY REPLACEMENT. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by New Business Development, LLC (Marietta, US). The FDA issued a Cleared decision on October 15, 2007 after a review of 83 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all New Business Development, LLC devices

FDA 510(k) Submission Details - K072029

510(k) Number K072029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2007
Decision Date October 15, 2007
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
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 213
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K072029.
MODIFICATION TO VALEO VBR
K073505 · Amedica Corp. · Jan 2008
VALEO VBR
K073125 · Amedica Corp. · Dec 2007
ZUMA
K071726 · Seaspine, Inc. · Oct 2007
NIKO CORPECTOMY SPACER
K072465 · Globus Medical, Inc. · Oct 2007
RELIANCE VBS SYSTEM
K063637 · Reliance Medical Systems, LLC · Sep 2007
LDR SPINE ROI-T SYSTEM
K072132 · Ldr Spine USA · Aug 2007