MOTO Partial Knee System— 510(k) K162084

Name: FDA 510(k) clearance K162084
Creator: U.S. Food and Drug Administration
Published: 2017-01-03

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K162084 for MOTO Partial Knee System, Substantially Equivalent on 2017-01-03. Applicant: Medacta International S.A.. Device class: 2.

Clearance details

Applicant: Medacta International S.A.
Product code: Code HSX
Device class: Class 2
Regulation: 21 CFR 888.3520
Advisory panel: Orthopedic
Date received: 2016-07-27
Decision date: 2017-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castel San Pietro (Ch), CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code HSX

view all

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

More clearances from Medacta International S.A.

view all

K253630 — Mpact 3D Metal Foam2026-08-28
K254202 — MectaLIF 3D Metal Anterior2026-05-05
K253940 — M.U.S.T. Pedicle Screw System - Extension2026-04-28
K253328 — GMK 3D Metal Tibial Tray Extension2026-02-26
K250644 — MSS - Monobloc stem2026-02-03

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.