Cleared Traditional

K072133 - AVAFLEX VERTEBRAL AUGMENTATION NEEDLE

K072133 is an FDA 510(k) clearance for AVAFLEX VERTEBRAL AUGMENTATION NEEDLE, manufactured by Cardinal Health, Inc.. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K072133 · Cardinal Health, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
110d
Days
Class 2
Risk

K072133 is an FDA 510(k) clearance for the AVAFLEX VERTEBRAL AUGMENTATION NEEDLE. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Cardinal Health, Inc. (Mcgaw Park, US). The FDA issued a Cleared decision on November 20, 2007 after a review of 110 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 Cardinal Health, Inc. devices

FDA 510(k) Submission Details - K072133

510(k) Number K072133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2007
Decision Date November 20, 2007
Days to Decision 110 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
12d faster than avg
Panel avg: 122d · This submission: 110d
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 50
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K072133.
AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020
K093463 · Care Fusion · Feb 2010
VERTAPLEX HV (SINGLE PACK AND DUAL PACK)
K091606 · Stryker Corp. · Oct 2009
STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT
K072118 · Stryker Corp. · Dec 2007
ARCUATE VERTEBRAL AUGMENTATION SYSTEM
K070527 · Medtronic Sofamor Danek · May 2007
ARCUATE VERTEBRAL AUGMENTATION SYSTEM
K063248 · Medtronic Sofamor Danek · Mar 2007
PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS-TA
K060425 · Arthrocare Corp. · Jul 2006