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510(k) K232802

TMINI™ Miniature Robotic System by THINK Surgical, Inc. — Product Code OLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2023
Date Received
September 12, 2023
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 THINK Surgical, Inc.

  • K260010 — TMINI® Miniature Robotic System (March 3, 2026)
  • K253661 — TMINI Miniature Robotic System (December 22, 2025)
  • K252544 — TMINI Miniature Robotic System (October 10, 2025)
  • K250877 — TMINI Miniature Robotic System (June 20, 2025)
  • K243481 — TMINI Miniature Robotic System (January 6, 2025)
  • K243285 — TMINI Miniature Robotic System (November 15, 2024)
  • K242264 — TMINI Miniature Robotic System (August 23, 2024)
  • K241031 — TMINI Miniature Robotic System (TMINI 1.1) (July 12, 2024)
  • K230202 — TMINI™ Miniature Robotic System (April 25, 2023)
  • K203468 — TCAT TKA Instrument Tray (December 20, 2021)

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)