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ROSA Partial 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

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1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K232533
Device name
ROSA Partial Knee System
Country / Region
Canada(CA)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2023-08-21
Decision date
2023-11-16
Submission type
Traditional
Technology type
Stereotactic Surgery(AI inferred)
Clinical applications
Knee SurgeryRobotic Assistance
Primary application
Knee Surgery
Classification source
AI classified

Indications for Use

The ROSA® Partial Knee System, for use with the ROSA®RECON platform, is indicated as a stereotaxic instrumentation system for Partial Knee replacement (PKA) 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 the knee implant components. The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and based on a three-dimensional representation of the bone structures determined preoperatively using compatible X-ray or MRI based imaging technologies. The ROSA® Partial Knee System is designed for use on a skeletally mature patient population. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the ROSA® Partial Knee System. The ROSA® Partial Knee System is to be used with Persona Partial Knee (PPK) fixed bearing knee replacement system in accordance with its indications and contraindications. Contraindications: The ROSA® Partial Knee System may not be suitable for use in case of: hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or acetabulum); hip pathology severely limiting range of motion (e.g. arthrodesis, severe contractures, chronic severe dislocation); active infections of the knee joint area; knee replacement revision surgery; presence of strong infrared sources or infrared reflectors in the vicinity of the trackers; contraindications for the implant as given by the implant manufacturer; and implants that are not compatible with the system.

Intended Use

The ROSA® Partial Knee System, for use with the ROSA®RECON platform, is indicated as a stereotaxic instrumentation system for Partial Knee replacement (PKA) 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 the knee implant components. The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and based on a three-dimensional representation of the bone structures determined preoperatively using compatible X-ray or MRI based imaging technologies.

Device Description

The ROSA® Partial Knee System for use with the ROSA® RECON Platform is used to assist surgeons in performing Partial Knee Arthroplasty (PKA) with features to assist with the bone resections as well as assessing the state of the soft tissues to facilitate implant positions intraoperatively. The system uses a Non-Device Medical Device Data System (MDDS) called the Zimmer Biomet Drive Portal which manages the creation and tracking of the surgical cases. The cases resides on the portal until it is uploaded to the ROSA® RECON Platform before surgeries. If the case is image-based, a 3D virtual bone model is generated pre-operatively by the PSI systems (X-PSI Knee System or CAS PSI Knee System) to create a 3D model of the patient's femur/tibia and allows the preparation of a pre-operative ROSA® Total Knee System (TKA) surgical plan. However, the pre-operative surgical plan is not provided in the ROSA® Partial Knee System and is only made available if a switch is performed intra-operatively from ROSA® Partial Knee System to the ROSA® Knee System. Landmarks taken intra-operatively on the patient's bony anatomy are used to create the intra-operative surgical plan. An image-less option is also available where landmarks taken intra-operatively on the patient's bony anatomy are used to create the surgical plan. Accuracy of resections, knee state evaluation, and soft tissue assessment are the same between image-based and imageless options as they are always based on intra-operative landmarks. The intra-operative workflow and surgical concepts implemented in the system remain close to the conventional PKA workflow. As such, at the time of the surgery, the system mainly assists the surgeon in (1) determining reference alignment axes in relation to anatomical landmarks, (2) planning the orthopedic implants location based on these reference alignment axes and orthopedic implant geometry (planning optionally based on using pre-operative imaging), and (3) precisely positioning the cut guide relative to the planned orthopedic implant location by using a robotic arm and (4) using the Zimmer Biomet Persona Partial Knee (PPK) spacer block to perform the femoral distal cut.

Summary parsed at:2026-06-19 05:48:53 UTC

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