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ROSA Knee System with UltraSound Imaging Platform (USIP)

Balmoral Medical, 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

3

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K252058
Device name
ROSA Knee System with UltraSound Imaging Platform (USIP)
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2025-07-01
Decision date
2026-02-06
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

ROSA Knee System with USIP for use with ROSA RECON platform, 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 the position and orientation of the femur and tibia as tracked by the ultrasound and optical systems. It is also based on the surgical plan specified by the surgeon intra-operatively on the robot user interface. To be able to perform this tracking, a virtual 3D bone model of the patient's femur and tibia are generated pre-operatively from a CT-scan of their leg. The ROSA Knee System with USIP is designed for use on skeletally mature patient population. It includes an ultrasound imaging system, a robotic arm, an optical sensor navigation system and accessories, surgical instruments, and a software system. It does not include a pre-operative planning feature. The ROSA Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: Persona® CR, Persona PS, Persona Ti-Nidium® CR, Persona Ti-Nidium PS and Persona IQ® The Smart Knee™.

Intended Use

ROSA Knee System with USIP for use with ROSA RECON platform, 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 the position and orientation of the femur and tibia as tracked by the ultrasound and optical systems. It is also based on the surgical plan specified by the surgeon intra-operatively on the robot user interface. To be able to perform this tracking, a virtual 3D bone model of the patient's femur and tibia are generated pre-operatively from a CT-scan of their leg. The ROSA Knee System with USIP is designed for use on skeletally mature patient population. It includes an ultrasound imaging system, a robotic arm, an optical sensor navigation system and accessories, surgical instruments, and a software system. It does not include a pre-operative planning feature. The ROSA Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: Persona® CR, Persona PS, Persona Ti-Nidium® CR, Persona Ti-Nidium PS and Persona IQ® The Smart Knee™.

Device Description

The ROSA® Knee System with USIP (Ultrasound Imaging Platform) is used to assist surgeons in performing Total Knee Arthroplasty (TKA) with features to assist with the bone resections. The USIP device is to be used with the Zimmer Biomet ROSA Knee System to perform TKA. The USIP device provides an ultrasound-based location solution for tibia and femur replacing the use of fluted pins placed in the femur and tibia. The USIP is composed of the ultrasound acquisition box, which connects to the ROSA Knee System and two belts; femur and tibia, which contain the ultrasound transducers. NavitrackERs are mounted on the femur and tibia belts and calibrated to locate the bone relative to the robot. The belts wrap or partially wrap the thigh (femur belt) and the calf (tibia belt) of the patient. The belts image the patient's bone via the ultrasound transducers contained in the belts.

Summary parsed at:2026-06-19 04:30:04 UTC

Predicate devices

3

K252058 references 3 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K252058 as a predicate