510(k) K250608

Mako Total Knee Application (3.0); Hybrid Tip Pointer by Mako Surgical Corp. — Product Code OLO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 25, 2025
Date Received: February 28, 2025
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 Mako Surgical Corp.

K260222 — Mako Total Knee Application (February 25, 2026)
K243751 — Mako Total Hip Application 5.0 (March 5, 2025)
K242373 — Mako Shoulder Application (1.0) (November 7, 2024)
K241011 — Mako Total Knee Application (June 11, 2024)
K220930 — Restoris Multi-Compartmental Knee System (June 2, 2022)
K220459 — Mako Total Knee Application (April 15, 2022)
K193515 — Mako Total Knee Application (July 14, 2020)
K193128 — Mako Total Hip Application (February 2, 2020)
K191998 — Mako Total Hip Application, Mako Total Knee Application (September 24, 2019)
K172301 — Mako Partial Knee Application (November 2, 2017)

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)