# K252058: ROSA Knee System with UltraSound Imaging Platform (USIP)

- Pathway: 510(k) (Traditional)
- Applicant: Balmoral Medical, LLC
- Decided: Feb 6, 2026 after 220 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 5.

## 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™.

Source page: https://510kreport.com/device/K252058
Methodology: https://510kreport.com/methodology