MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III— 510(k) K082081

Clearance details

Applicant

Mako Surgical Corp.

Product code

Code HSX

Device class

Class 2

Regulation

21 CFR 888.3520

Advisory panel

Orthopedic

Date received

2008-07-23

Decision date

2008-10-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Fort Lauderdale, FL, US

• K261609 — Freedom Partial Knee System2026-08-04
• K260796 — Tahoe Unicondylar Knee System with TiNbN Overcoat2026-04-02
• K251771 — Cambridge Partial Knee2025-12-16
• K251834 — Persona Partial Knee2025-08-15
• K251618 — MOTO Partial Knee System Extension2025-07-24

• 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

Injury

1,003

Other

1

Total

1,004

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 →