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FDA 510(k)

SkyWalker Total Knee System

K-Number: K213873 · 2022-07-07

ApplicantMicroport Navibot International, LLC
Decision Date2022-07-07
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SkyWalker Total Knee System is a medical device manufactured by Microport Navibot International, LLC. It received FDA 510(k) clearance on 2022-07-07 under approval number K213873. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SkyWalker Total Knee System?

SkyWalker Total Knee System is a medical device that received FDA 510(k) clearance on 2022-07-07. It is manufactured by Microport Navibot International, LLC. The 510(k) number is K213873.

When was SkyWalker Total Knee System approved by the FDA?

SkyWalker Total Knee System received FDA 510(k) clearance on 2022-07-07, under approval number K213873.

What company makes SkyWalker Total Knee System?

SkyWalker Total Knee System is manufactured by Microport Navibot International, LLC.

What is the FDA product code for SkyWalker Total Knee System?

The FDA product code for SkyWalker Total Knee System is OLO.

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT04325022 Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA ACTIVE_NOT_RECRUITING NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED

Related PubMed Literature

PMID: 41209898 Evaluation of a Single Knee System: All-Polyethylene Tibia (APT) vs. Metal-Backed Tibia (MBT) in Primary Total Knee Arthroplasty. Cureus (2025) PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 29258356 Grave fraudulence in medical device research: a narrative review of the PIN seeding study for the Pinnacle hip system. Accountability in research (2018) PMID: 28280294 Assessing the cost burden of United States FDA-mandated post-approval studies for medical devices. Journal of health care finance (2016)

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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