Cleared Traditional

K162062 - AVAmax Vertebral Balloon

K162062 is the FDA 510(k) clearance for AVAmax Vertebral Balloon by Stryker Corporation. It is a Class 2 Orthopedic device (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

Submission Details

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.

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 376
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K162062.
Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)
K172116 · Stryker Corporation · Jan 2018
FMS VUE II Fluid Management and Tissue Debridement System
K171237 · Medos International SARL · Jan 2018
Smith & Nephew 25 Fluid Management System
K171794 · Smith & Nephew, Inc. · Jun 2017
ULTRA Telescopes
K160249 · Olympus Winter & Ibe GmbH · Apr 2016
Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing
K151932 · Stryker Corporation · Mar 2016
AVAflex Vertebral Balloon System
K151125 · Care Fusion · Nov 2015