ROSA® Shoulder System
FDA 510(k) K260582 · Orthosoft Inc. (d/b/a) Zimmer CAS
510(k) numberK260582
Submission
- Device name
- ROSA® Shoulder System
- Applicant
- Orthosoft Inc. (d/b/a) Zimmer CAS
Montreal, CA - Received
- February 20, 2026
- Decision date
- May 21, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLO – Orthopedic Stereotaxic Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Specialty
- Neurology
Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
Other 510(k)s with product code OLO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262506 | Remex Spine Surgery Navigation - Universal InstrumentsOLO · Special | Remex Medical Corp. | 08/20/2026SE |
| K261410 | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…OLO · Traditional | Suite 201, National Innovation Centre | 07/30/2026SE |
| K261205 | SPINEART Navigation Instrument SystemOLO · Traditional | Spineart SA | 07/29/2026SE |
| K262121 | Ion-L Navigated InstrumentsOLO · Special | SurGenTec, LLC | 07/24/2026SE |
| K261024 | TMINI Miniature Robotic SystemOLO · Traditional | THINK Surgical, Inc. | 07/24/2026SE |
| K261113 | Op.n Spine Navigation and Robotic GuidanceOLO · Traditional | Ecential Robotics | 07/22/2026SE |
| K261852 | OTS HipOLO · Special | Ortoma AB | 07/01/2026SE |
| K253921 | VERTICALE® Navigation InstrumentsOLO · Traditional | Silony Medical GmbH | 06/26/2026SE |
| K260480 | VELYS Robotic-Assisted SolutionOLO · Traditional | Depuy Ireland UC | 06/25/2026SE |
| K260369 | Dynamis Robotic Surgical SystemOLO · Traditional | LEM Surgical AG | 06/20/2026SE |
More from LEM Surgical AG
| 510(k) | Device | Decision |
|---|---|---|
| K261510 | Signature ONE SystemQHE · Special | 06/04/2026SE |
| K260104 | Signature ONE SystemQHE · Special | 02/04/2026SE |
| K251314 | Rosa® Knee SystemOLO · Traditional | 11/13/2025SE |
| K242864 | ROSA® Knee SystemOLO · Special | 10/18/2024SE |
| K233199 | ROSA® Shoulder SystemOLO · Traditional | 02/21/2024SE |
| K232425 | Signature ONE SystemQHE · Traditional | 12/12/2023SE |
| K230567 | OptiVu ROSA® MxRSBF · Traditional | 06/13/2023SE |
| K231162 | ROSA Hip SystemLLZ · Special | 05/23/2023SE |
| K230180 | Rosa Knee SystemOLO · Special | 02/22/2023SE |
| K220733 | OptiVu ROSA MxRSBF · Traditional | 07/29/2022SE |
Questions and answers
When was ROSA® Shoulder System cleared by the FDA?
ROSA® Shoulder System (K260582) received a 510(k) decision of Substantially Equivalent on May 21, 2026, 90 days after the submission was received.
What is the product code of K260582?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.