Cleared Traditional

K063248 - ARCUATE VERTEBRAL AUGMENTATION SYSTEM

K063248 is an FDA 510(k) clearance for ARCUATE VERTEBRAL AUGMENTATION SYSTEM, manufactured by Medtronic Sofamor Danek. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K063248 · Medtronic Sofamor Danek · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
138d
Days
Class 2
Risk

K063248 is an FDA 510(k) clearance for the ARCUATE VERTEBRAL AUGMENTATION SYSTEM. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on March 13, 2007 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - 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 Medtronic Sofamor Danek devices

FDA 510(k) Submission Details - K063248

510(k) Number K063248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2006
Decision Date March 13, 2007
Days to Decision 138 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
16d slower than avg
Panel avg: 122d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NDN Device Classification - Class 2, Special Controls

Product Code NDN Cement, Bone, Vertebroplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
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 - NDN Cement, Bone, Vertebroplasty

All 96
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K063248.
AVAFLEX VERTEBRAL AUGMENTATION NEEDLE
K072133 · Cardinal Health, Inc. · Nov 2007
SPACE 360 DELIVERY SYSTEM
K070351 · Dfine, Inc. · Jun 2007
ARCUATE VERTEBRAL AUGMENTATION SYSTEM
K070527 · Medtronic Sofamor Danek · May 2007
VSPSPN
K063438 · Tecres S.P.A. · Jan 2007
CONFIDENCE FENESTRATED INTRODUCER NEEDLE
K063067 · Disc-O-Tech Medical Technologies, Ltd. · Nov 2006
KIT MENDEC SPINE AND DELIVERY SYSTEM
K062452 · Tecres S.P.A. · Sep 2006