Cleared Traditional

K151125 - AVAflex Vertebral Balloon System

K151125 is an FDA 510(k) clearance for AVAflex Vertebral Balloon System, 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 210-day FDA review.

K151125 · Care Fusion · Orthopedic device
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Nov 2015
Decision
210d
Days
Class 2
Risk

K151125 is an FDA 510(k) clearance for the AVAflex Vertebral Balloon System. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Care Fusion (Vernon Hills, US). The FDA issued a Cleared decision on November 24, 2015 after a review of 210 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 - K151125

510(k) Number K151125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2015
Decision Date November 24, 2015
Days to Decision 210 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
88d slower than avg
Panel avg: 122d · This submission: 210d
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 K151125.
Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing
K151932 · Stryker Corporation · Mar 2016
SPINAUT-V, SPINAUT-S, SPINAUT-I
K151268 · Imedicom Co., Ltd. · Mar 2016
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
K153548 · Visionsense, Ltd. · Feb 2016
AVAmax Vertebral Balloon
K150523 · Care Fusion · Oct 2015
KYPHON ELEMENT Inflatable Bone Tamp
K151532 · Medtronic, Inc. · Jul 2015
NeedleCam HD Visualization System
K143705 · Biovision Technologies, LLC · Feb 2015