Benchmed logo
Categories

SkyWalker Total Knee System

Microport Navibot International, LLC

Country / Region:United States (US)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

Summary PDF

Company

United States (US)

Product code

OLO
21 CFR 882.4560

Predicate devices

6

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K213873
Device name
SkyWalker Total Knee System
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2021-12-13
Decision date
2022-07-07
Submission type
Traditional
Technology type
Stereotactic Surgery(AI inferred)
Clinical applications
Knee SurgeryNavigation System
Primary application
Knee Surgery
Classification source
AI classified

Indications for Use

SkyWalker Total Knee System is intended to assist the surgeon to perform Total Knee Arthroplasty (TKA) procedures by providing software-defined spatial boundaries for orientation and reference information to anatomical structures for the accurate placement of compatible knee implant components. It is indicated for use in TKA procedures in which the selection of stereotactic surgery is appropriate and the anatomical bony structures can be identified with a CT based model. The targeted population as well as indications and contraindications have the same characteristics as those suitable for the following implants compatible with SkyWalker Total Knee System: EVOLUTION@ MP TOTAL KNEE SYSTEM, EVOLUTION@ MP TOTAL KNEE SYSTEM, ADVANCE@ STATURE FEMORAL COMPONENT, ADVANCE® TIBIAL COMPONENT, and ADVANCE® KNEE SYSTEM.

Intended Use

SkyWalker Total Knee System is intended to assist the surgeon to perform Total Knee Arthroplasty (TKA) procedures by providing software-defined spatial boundaries for orientation and reference information to anatomical structures for the accurate placement of compatible knee implant components. It is indicated for use in TKA procedures in which the selection of stereotactic surgery is appropriate and the anatomical bony structures can be identified with a CT based model.

Device Description

SkyWalker Total Knee System consists of a navigation console, a surgical console, cables, software system, surgical instruments and accessories. The navigation console includes a navigation trolley, an optical tracking device, a primary monitor and a surgeon monitor. The surgical console includes a robotic arm, a robotic arm trolley and a foot pedal. The TKA surgery workflow under the guidance of SkyWalker Total Knee System can be divided into preoperative procedure and intraoperative procedure. The preoperative procedure is to assist the user with preoperative planning by using patient CT image data and providing reference information to anatomical structures to make a surgical plan for the TKA surgery. In the intraoperative procedure, Skywalker Total Knee System can provide stereotactic guidance for real-time orientation of the cutting block to a target position with a target pose. When the robotic arm reaches the target position, the cutting block is being held in an expected pose, then the surgeon could be able to accurately perform knee resection.

Summary parsed at:2026-06-24 04:16:50 UTC

Predicate devices

6

K213873 references 6 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K213873 as a predicate