# K182964: ROSA Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Orthosoft Inc (D/B/A Zimmer Cas)
- Decided: Jan 24, 2019 after 91 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: 13 generations back to K905070 (1991). 58 ancestors in all.
29 later devices descend from it; 8 cite it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151511: ROSA Spine, Medtech S.A (2016) Summary page 4.
- K172219: Mako Total Knee Application, Mako Surgical Corp. (2017) Summary page 4.

## Most influential descendants
- K230202: TMINI™ Miniature Robotic System (2023), 10 descendants of its own
- K232802: TMINI™ Miniature Robotic System (2023), 9 descendants of its own
- K241031: TMINI Miniature Robotic System (TMINI 1.1) (2024), 8 descendants of its own
- K221928: ROSA® Knee System (2022), 8 descendants of its own
- K242264: TMINI Miniature Robotic System (2024), 7 descendants of its own

## 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 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. It includes a robotic arm, an optical sensor navigation system and accessories, software system, surgical instruments and accessories. 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, Vanguard® CR, and Vanguard PS.

Source page: https://510kreport.com/device/K182964
Methodology: https://510kreport.com/methodology