# K213873: SkyWalker Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Microport Navibot International, LLC
- Decided: Jul 7, 2022 after 206 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K905070 (1991). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182964: ROSA Knee System, Orthosoft Inc (D/B/A Zimmer Cas) (2019) Summary page 4.

## 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. SkyWalker Total Knee System includes surgical console (a robotic arm platform), navigation console (an optical tracking navigation platform), software system (including preoperative planning software), cables, surgical instruments and accessories. The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a preoperative plan derived from imported CT images. 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.

Source page: https://510kreport.com/device/K213873
Methodology: https://510kreport.com/methodology