Cleared Traditional

K131820 - AVAMAX VERTEBRAL BALLOON SYSTEM

K131820 is the FDA 510(k) clearance for AVAMAX VERTEBRAL BALLOON SYSTEM by Care Fusion. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K131820 · Care Fusion · Orthopedic device
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Oct 2013
Decision
106d
Days
Class 2
Risk

K131820 is an FDA 510(k) clearance for the AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AV.... Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Care Fusion (Vernon Hills, US). The FDA issued a Cleared decision on October 4, 2013 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - 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

Submission Details

510(k) Number K131820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2013
Decision Date October 04, 2013
Days to Decision 106 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 faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - HRX Arthroscope

All 379
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K131820.
AVAmax Vertebral Balloon
K150523 · Care Fusion · Oct 2015
KYPHON ELEMENT Inflatable Bone Tamp
K151532 · Medtronic, Inc. · Jul 2015
MITEK ARTHROSCOPES
K133941 · Medos International SARL · Apr 2014
AVAFLEX VERTEBRAL BALLOON SYSTEM
K131824 · Care Fusion · Oct 2013
4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS
K131191 · Depuy Mitek, A Johnson & Johnson Company · Jul 2013
OMNICUT RESECTION BLADE
K130912 · Depuy Mitek, A Johnson & Johnson Company · Jun 2013