Cleared Traditional

K162062 - AVAmax Vertebral Balloon, AVAflex Vertebral Balloon

K162062 is an FDA 510(k) clearance for AVAmax Vertebral Balloon, manufactured by Stryker Corporation. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K162062 · Stryker Corporation · Orthopedic device
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Nov 2016
Decision
98d
Days
Class 2
Risk

K162062 is an FDA 510(k) clearance for the AVAmax Vertebral Balloon, AVAflex Vertebral Balloon. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on November 1, 2016 after a review of 98 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 Stryker Corporation devices

FDA 510(k) Submission Details - K162062

510(k) Number K162062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2016
Decision Date November 01, 2016
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
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 K162062.
Smith & Nephew 25 Fluid Management System
K171794 · Smith & Nephew, Inc. · Jun 2017
JOINIX CANNULAR SYSTEM
K162070 · Aju Pharm Co., Ltd. · Mar 2017
Intra medullary endo-transilluminating device (iMET device)
K163037 · WeMED Bio-Tech, Inc. · Feb 2017
PORTAGE System
K161878 · Baylis Medical Company, Inc. · Sep 2016
mi-eye 2, mi-eye 2 monitor
K162475 · Trice Medical · Sep 2016
Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula
K152511 · Prosurg, Inc. · Jul 2016