# K260582: ROSA® Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Orthosoft Inc. (d/b/a) Zimmer CAS
- Decided: May 21, 2026 after 90 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: 17 generations back to K905070 (1991). 159 ancestors in all.
No later device cites it as a predicate yet.
0 of 160 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233199: ROSA® Shoulder System, Orthosoft Inc (D/B/A Zimmer Cas) (2024) Summary page 5.

## Indications for use
The ROSA Shoulder System, for use with the ROSA Recon Platform, is indicated as a stereotaxic instrument system for total shoulder arthroplasty (TSA) surgery. It is used to assist the surgeon in providing software-defined spatial boundaries for orientation and reference to identifiable anatomical structures for the accurate placement of the shoulder implant components. The Robotic Arm placement is performed relative to anatomical landmarks and bony anatomy as recorded using the system intra-operatively, and based on a three-dimensional representation of the bone structures determined pre-operatively using compatible CT-based imaging technology. It includes a Robotic Arm, an Optical Sensor navigation system and accessories, software system, surgical instruments and accessories. The ROSA Shoulder System is designed for a skeletally mature patient population. The target population has the same characteristics as the population targeted by the implants compatible with the ROSA Shoulder System. The ROSA Shoulder System is to be used with the following shoulder replacement systems per their indications and contraindications: * Humerus implants: Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, Identity® Shoulder System and Identity® Reverse Shoulder System * Glenoid implants: Alliance® Glenoid and Comprehensive® Reverse Shoulder System

Source page: https://510kreport.com/device/K260582
Methodology: https://510kreport.com/methodology