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ROSA® Knee System

Orthosoft Inc. (d/b/a) Zimmer CAS

Country / Region:Canada (CA)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

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Product code

OLO
21 CFR 882.4560

Predicate devices

1

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0

Device details

FDA 510(k) registration fields

K number
K213708
Device name
ROSA® Knee System
Country / Region
Canada(CA)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2021-11-24
Decision date
2022-04-22
Submission type
Traditional
Technology type
Stereotactic Surgery(AI inferred)
Clinical applications
Knee Surgery
Primary application
Knee Surgery
Classification source
AI classified

Indications for Use

The ROSA® Knee System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the ROSA® Knee System. The ROSA® Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: NexGen® CR, NexGen CR-Flex, NexGen CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender, Persona® CR, Persona PS, Persona IQ, Vanguard® CR, and Vanguard PS.

Intended Use

The ROSA® Knee System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components. The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and based on a surgical plan, optionally determined pre-operatively using compatible X-ray or MRI based surgical planning tools.

Device Description

The ROSA® Knee System is used to assist surgeons in performing Total Knee Arthroplasty (TKA) with features to assist with the bone resections as well as assessing the state of the soft tissues to facilitate implant positioning intra-operatively. The ROSA® Knee System includes a robotic arm, an optical sensor navigation system and accessories, software system, surgical instruments and accessories. The intraoperative workflow and surgical concepts implemented in the system remain close to the conventional TKA workflow. The system assists the surgeon in determining reference alignment axes in relation to anatomical landmarks, planning the orthopedic implants location based on these reference alignment axes and orthopedic implant geometry, assisting in joint balancing, and precisely positioning the cut guide relative to the planned orthopedic implant location by using a robotic arm.

Summary parsed at:2026-06-24 04:16:11 UTC

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