MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II— 510(k) K080368

Name: FDA 510(k) clearance K080368
Creator: U.S. Food and Drug Administration
Published: 2008-06-20

Substantially Equivalent

Mako Surgical Corp.

FDA 510(k) clearance K080368 for MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II, Substantially Equivalent on 2008-06-20. Applicant: Mako Surgical Corp.. Device class: 2.

Clearance details

Applicant: Mako Surgical Corp.
Product code: Code HSX
Device class: Class 2
Regulation: 21 CFR 888.3520
Advisory panel: Orthopedic
Date received: 2008-02-12
Decision date: 2008-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ft. Lauderdale, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HSX

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K251771 — Cambridge Partial Knee2025-12-16
K251834 — Persona Partial Knee2025-08-15
K251618 — MOTO Partial Knee System Extension2025-07-24

More clearances from Mako Surgical Corp.

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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

Adverse events under product code HSX

product code HSX

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.