Total Knee Application (TKA)— 510(k) K143752

Clearance details

Applicant

Mako Surgical Corp.

Product code

Code OLO

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

2014-12-31

Decision date

2015-08-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Fort Lauderdale, FL, US

• K262506 — Remex Spine Surgery Navigation - Universal Instruments2026-08-20
• K261410 — Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))2026-07-30
• K261205 — SPINEART Navigation Instrument System2026-07-29
• K261024 — TMINI Miniature Robotic System2026-07-24
• K262121 — Ion-L Navigated Instruments2026-07-24

• K260222 — Mako Total Knee Application2026-02-25
• K250608 — Mako Total Knee Application (3.0); Hybrid Tip Pointer2025-04-25
• K243751 — Mako Total Hip Application 5.02025-03-05
• K242373 — Mako Shoulder Application (1.0)2024-11-07
• K241011 — Mako Total Knee Application2024-06-11

Death

11

Injury

2,799

Malfunction

11,105

Other

1

Total

13,916

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1823-2019 — 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)Class II·Terminated·Mako Surgical Corporation·20190425
• Z-1824-2019 — 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)Class II·Terminated·Mako Surgical Corporation·20190425

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143752.