Home / 510(k) Clearances / K242864

510(k) K242864

ROSA® Knee System by Orthosoft Inc. (d/b/a) Zimmer CAS — Product Code OLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2024
Date Received
September 20, 2024
Clearance Type
Special
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

  • K260104 — Signature™ ONE System (February 4, 2026)
  • K251314 — Rosa® Knee System (November 13, 2025)

Other clearances for product code OLO

  • K260010 — TMINI® Miniature Robotic System (March 3, 2026)
  • K260222 — Mako Total Knee Application (February 25, 2026)
  • K252989 — “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set (February 20, 2026)
  • K254148 — VERTICALE GPS Instruments (February 19, 2026)
  • K252597 — Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For U (February 19, 2026)
  • K253623 — Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Upda (February 19, 2026)
  • K253381 — Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application (February 12, 2026)
  • K252873 — Q Interbody Instruments (February 6, 2026)
  • K252058 — ROSA Knee System with UltraSound Imaging Platform (USIP) (February 6, 2026)
  • K252871 — Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite (February 6, 2026)