Cleared Traditional

K093463 - AVAMAX VERTEBRAL BALLOON MODEL VBS1010

K093463 is an FDA 510(k) clearance for AVAMAX VERTEBRAL BALLOON MODEL VBS1010, manufactured by Care Fusion. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K093463 · Care Fusion · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
112d
Days
Class 2
Risk

K093463 is an FDA 510(k) clearance for the AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Care Fusion (Waukegan, US). The FDA issued a Cleared decision on February 26, 2010 after a review of 112 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 Care Fusion devices

FDA 510(k) Submission Details - K093463

510(k) Number K093463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2009
Decision Date February 26, 2010
Days to Decision 112 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
10d faster than avg
Panel avg: 122d · This submission: 112d
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 49
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K093463.
AVAMAX VERTEBRAL BALLOON
K103064 · Care Fusion · Jan 2011
PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE
K100479 · Arthrocare Corp. · Sep 2010
KYPH X HV-R BONE CEMENT
K093828 · Medtronic, Inc. · Aug 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