Cleared Traditional

K103064 - AVAMAX VERTEBRAL BALLOON

K103064 is an FDA 510(k) clearance for AVAMAX VERTEBRAL BALLOON, 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 84-day FDA review.

K103064 · Care Fusion · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
84d
Days
Class 2
Risk

K103064 is an FDA 510(k) clearance for the AVAMAX VERTEBRAL BALLOON. 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 January 10, 2011 after a review of 84 days - a notably fast clearance cycle.

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: 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 Care Fusion devices

FDA 510(k) Submission Details - K103064

510(k) Number K103064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2010
Decision Date January 10, 2011
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
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 K103064.
IVAS 2-10MM (10 GUAGE) BALLON CATHETER
K103807 · Stryker Corporation · Jun 2011
KYPHON XPEDE BONE CEMENT
K102397 · Medtronic · Feb 2011
ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE
K110183 · Arthrocare Corp. · Feb 2011
PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE
K100479 · Arthrocare Corp. · Sep 2010
KYPH X HV-R BONE CEMENT
K093828 · Medtronic, Inc. · Aug 2010
AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020
K093463 · Care Fusion · Feb 2010