M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System— 510(k) K193083

Name: FDA 510(k) clearance K193083
Creator: U.S. Food and Drug Administration
Published: 2019-12-03

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K193083 for M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System, Substantially Equivalent on 2019-12-03. Applicant: Medacta International S.A.. Device class: 2.

Clearance details

Applicant: Medacta International S.A.
Product code: Code OUR
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2019-11-05
Decision date: 2019-12-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Castel San Pietro (Ch), CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code OUR

view all

K261381 — TiLink-L SI Joint Fusion System2026-08-24
K260477 — CATAMARAN SI Joint Fusion System2026-04-08
K253488 — iFuse INTRA Ti Implant System2026-02-11
K253611 — Falco Fusion System2026-01-29
K252834 — Sacroiliac Joint Truss System (SJTS)2026-01-28

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 OUR

product code OUR

Death: 3
Injury: 347
Total: 350

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.