Cleared Traditional

K051525 - ARX SPINAL SYSTEM

K051525 is an FDA 510(k) clearance for ARX SPINAL SYSTEM, manufactured by Amedica Corp.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K051525 · Amedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
254d
Days
Class 2
Risk

K051525 is an FDA 510(k) clearance for the ARX SPINAL SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Amedica Corp. (Salt Lake City, US). The FDA issued a Cleared decision on February 17, 2006 after a review of 254 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Amedica Corp. devices

FDA 510(k) Submission Details - K051525

510(k) Number K051525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2005
Decision Date February 17, 2006
Days to Decision 254 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 122d · This submission: 254d
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 210
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K051525.
STAXX XD SYSTEM
K052670 · Spine Wave, Inc. · Apr 2006
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
SYNFIX-LR
K053508 · Synthes Spine Co.Lp · Feb 2006
SEASPINE VBR SYSTEM
K052170 · Seaspine, Inc. · Dec 2005
GRAFTCAGE TLX
K051781 · Osteotech, Inc. · Dec 2005