# K250108: OptiVu™ Shoulder

- Pathway: 510(k) (Traditional)
- Applicant: Mr Surgical Solutions, LLC
- Decided: Jul 9, 2025 after 174 days
- Product code: SBF (Orthopedic Augmented Reality)
- 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). 266 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 267 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243975: Knee+, Pixee Medical (2025). Cleared while this submission was under review Summary page 5.
- K210153: NextAR RSA Platform, Medacta International S.A. (2021) Summary page 5.
- K233199: ROSA® Shoulder System, Orthosoft Inc (D/B/A Zimmer Cas) (2024) Summary page 5.

## Most influential descendants
- K252170: OptiVu™ Shoulder (2025), 0 descendants of its own

## Indications for use
OptiVu Shoulder is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures (humerus and scapula), humerus resection, and aligning the endoprosthesis with the anatomical structures, provided that the required anatomical landmarks can be identified on the patient’s preoperative CT scan. OptiVu Shoulder utilizes pre-operative planning files provided by the Zimmer CAS Signature ONE™ System. OptiVu Shoulder is compatible with any humeral implants that are supported by the Signature ONE™ System. OptiVu Shoulder is specifically indicated for total shoulder arthroplasty using the Zimmer Biomet Alliance® Glenoid system or reverse shoulder arthroplasty using the Comprehensive® Reverse Shoulder system, to aid the surgeon in locating anatomical structures (humerus and scapula), humerus resection, and aligning the glenoid component with the anatomical structures. OptiVu Shoulder includes an augmented reality (AR) head-mounted display (HMD) (OptiVu Tilt with HoloLens 2) and trackers to register and optically track anatomical landmarks and surgical instruments in real-time during the procedure. The HMD should not be relied upon solely and should always be used in conjunction with traditional methods.

Source page: https://510kreport.com/device/K250108
Methodology: https://510kreport.com/methodology