Cleared Traditional

K150523 - AVAmax Vertebral Balloon

K150523 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 HRX cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K150523 · Care Fusion · Orthopedic device
Download Printable Device Report (PDF)
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Oct 2015
Decision
241d
Days
Class 2
Risk

K150523 is an FDA 510(k) clearance for the AVAmax Vertebral Balloon. 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 29, 2015 after a review of 241 days - an extended review cycle.

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

FDA 510(k) Submission Details - K150523

510(k) Number K150523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2015
Decision Date October 29, 2015
Days to Decision 241 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
119d slower than avg
Panel avg: 122d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRX Device Classification - Class 2, Special Controls

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 530
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K150523.
SPINAUT-V, SPINAUT-S, SPINAUT-I
K151268 · Imedicom Co., Ltd. · Mar 2016
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
K153548 · Visionsense, Ltd. · Feb 2016
AVAflex Vertebral Balloon System
K151125 · Care Fusion · Nov 2015
KYPHON ELEMENT Inflatable Bone Tamp
K151532 · Medtronic, Inc. · Jul 2015
NeedleCam HD Visualization System
K143705 · Biovision Technologies, LLC · Feb 2015
HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR
K141557 · Gallini Medical Devices, Srl · Dec 2014