Cleared Traditional

Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)

K172116 · Stryker Corporation · Orthopedic
Jan 2018
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K172116 is an FDA 510(k) clearance for the Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter), a Arthroscope (Class II — Special Controls, product code HRX), submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on January 25, 2018, 196 days after receiving the submission on July 13, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number K172116 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 2017
Decision Date January 25, 2018
Days to Decision 196 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRX — Arthroscope
Device Class Class II — 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).

Similar Devices — HRX Arthroscope

All 678
VantageTM Lumbar Decompression Kit
K252546 · Allevion Medical, LLC · Mar 2026
MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)
K253217 · Medimaging Integrated Solution, Inc (Miis) · Dec 2025
PUREVUE? FMS
K250795 · W.O.M. World of Medicine GmbH · Dec 2025
Articulator Arthroscopic Bur
K252666 · Joint Preservation Innovations, LLC · Nov 2025
Kyphoplasty Balloon Dilatation Catheters
K252458 · Shanghai Lange Medtech Co., Ltd. · Nov 2025
TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly
K252020 · Hand Biomechanics Lab, Inc. · Oct 2025

More from Stryker Corporation

View all
Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
K232157 · GCJ · Aug 2023
Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System
K212194 · HAW · Feb 2023
Sonopet 1Q 3 7cm 1Q Large
K223770 · LFL · Feb 2023
Aviator? Anterior Cervical Plating (ACP) System, LITe? Plate System, DynaTran? Anterior Cervical Plating (ACP) System, Reflex? Hybrid ACP System, UniVise? Spinous Process Fixation Plate
K221728 · KWQ · Oct 2022
OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device
K221074 · GEI · Sep 2022