Cleared Traditional

K053080 - GRAFTCAGE ACX

K053080 is the FDA 510(k) clearance for GRAFTCAGE ACX by Osteotech, Inc.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K053080 · Osteotech, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Dec 2005
Decision
29d
Days
Class 2
Risk

K053080 is an FDA 510(k) clearance for the GRAFTCAGE ACX. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Osteotech, Inc. (Eatontown, US). The FDA issued a Cleared decision on December 1, 2005 after a review of 29 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 Osteotech, Inc. devices

Submission Details

510(k) Number K053080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2005
Decision Date December 01, 2005
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
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 159
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K053080.
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K060719 · Medtronic Sofamor Danek · Apr 2006
CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM
K060350 · Blackstone Medical, Inc. · Feb 2006
NUVASIVE COROENT EXTENSURE SYSTEM
K052210 · Nuvasive, Inc. · Dec 2005
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K052931 · Medtronic Sofamor Danek · Nov 2005
STRYKER SPINE AVS ASL PEEK SPACER
K051205 · Stryker Spine · Nov 2005
CONCORDE VBR SPINAL SYSTEM
K052746 · Depuy Spine, Inc. · Oct 2005