510(k) K233199

ROSA® Shoulder System by Orthosoft Inc (D/B/A Zimmer Cas) — Product Code OLO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 21, 2024
Date Received: September 28, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Orthopedic Stereotaxic Instrument
Device Class: Class II
Regulation Number: 882.4560
Review Panel: OR
Submission Type

Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

Other clearances by Orthosoft Inc (D/B/A Zimmer Cas)

K230567 — OptiVu ROSA® MxR (June 13, 2023)
K231162 — ROSA Hip System (May 23, 2023)
K230180 — Rosa Knee System (February 22, 2023)
K220733 — OptiVu ROSA MxR (July 29, 2022)
K213708 — ROSA® Knee System (April 22, 2022)
K212560 — Signature ONE System (October 12, 2021)
K200615 — Signature ONE System (June 5, 2020)
K192080 — iASSIST Knee System (November 5, 2019)
K192074 — Signature ONE System (August 30, 2019)
K183544 — Efficient Care 3D Planning (August 23, 2019)

Other clearances for product code OLO

K260011 — Foundation Surgical Navigated Lateral Disc Prep Instruments (April 16, 2026)
K254158 — SPINEART Navigation Instrument System (April 9, 2026)
K260240 — SYMPHONY Navigation Ready Instruments (March 27, 2026)
K260601 — REAL INTELLIGENCE CORI (March 26, 2026)
K252037 — CUVIS-joint (CJ150) (March 25, 2026)
K253604 — TiLink-L Navigation Instruments (March 20, 2026)
K253444 — EUROPA Posterior Cervical Fusion Navigated Instruments (March 18, 2026)
K260546 — Q Pedicle Instruments (March 17, 2026)
K260010 — TMINI® Miniature Robotic System (March 3, 2026)
K260222 — Mako Total Knee Application (February 25, 2026)