Manufacturer
Orthosoft Inc. (d/b/a) Zimmer CASROSA® Knee System
Orthosoft Inc. (d/b/a) Zimmer CAS
Country / Region:Canada (CA)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Cited as predicate
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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