MUTARS Cemented Femoral Stems— 510(k) K200045

Clearance details

Applicant

Implantcast GmbH

Product code

Code MEH

Device class

Class 2

Regulation

21 CFR 888.3353

Advisory panel

Orthopedic

Date received

2020-01-08

Decision date

2020-10-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Buxtehude, DE

• K261576 — Icona Hip Stem2026-08-10
• K250375 — Allure Hip Stem and Intramedullary Plugs2025-11-05
• K251166 — Mfinity Femoral System2025-06-13
• K251052 — Trivicta® Hip Stem2025-05-22
• K242315 — Resolve Modular Revision Hip Stem2025-05-01

• K252451 — EPORE® XO cup system2026-04-24
• K260037 — implantcast Packaging System Update2026-03-30
• K252401 — implaFit® short stems2026-03-12
• K241944 — AGILON® XO Shoulder Replacement System2025-03-10
• K240391 — MUTARS® femoral stem cemented 160 mm and 200 mm2024-10-24

Injury

2,021

Total

2,021

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 →