MUTARS Cemented Femoral Stems
FDA 510(k) K200045 · Implantcast GmbH
510(k) numberK200045
Submission
- Device name
- MUTARS Cemented Femoral Stems
- Applicant
- Implantcast GmbH
Buxtehude, DE - Received
- January 8, 2020
- Decision date
- October 16, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MEH – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3353
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MEH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261576 | Icona Hip StemMEH · Traditional | Corin, Ltd. | 08/10/2026SE |
| K250375 | Allure Hip Stem and Intramedullary PlugsMEH · Traditional | Waldemar Link GmbH & Co. KG | 11/05/2025SE |
| K251166 | Mfinity Femoral SystemMEH · Traditional | Medacta International S.A. | 06/13/2025SE |
| K251052 | Trivicta® Hip StemMEH · Traditional | Ortho Development Corp. | 05/22/2025SE |
| K242315 | Resolve Modular Revision Hip StemMEH · Traditional | United Orthopedic Corporation | 05/01/2025SE |
| K243839 | Alteon® HA Femoral StemsMEH · Traditional | Exactech, Inc. | 03/10/2025SE |
| K243162 | World LinerMEH · Special | Signature Orthopaedics Pty, Ltd. | 11/25/2024SE |
| K241472 | Icona Hip StemMEH · Traditional | Corin U.S.A. Limited | 10/03/2024SE |
| K241875 | TheRay Collared and Collarless Femoral StemMEH · Traditional | Nextstep Arthropedix | 09/13/2024SE |
| K241690 | Logical Liner; World Liner; World Knee PatellaMEH · Special | Signature Orthopaedics Pty, Ltd. | 08/01/2024SE |
More from Signature Orthopaedics Pty, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K252451 | EPORE® XO cup systemOQI · Traditional | 04/24/2026SE |
| K260037 | implantcast Packaging System UpdateLZO · Traditional | 03/30/2026SE |
| K252401 | implaFit® short stemsLZO · Traditional | 03/12/2026SE |
| K241944 | AGILON® XO Shoulder Replacement SystemKWT · Traditional | 03/10/2025SE |
| K240391 | MUTARS® femoral stem cemented 160 mm and 200 mmLZO · Traditional | 10/24/2024SE |
| K234044 | ACS® LD FB Knee SystemJWH · Traditional | 09/06/2024SE |
| K240834 | EcoFit® short stem cementless cpTiLZO · Traditional | 06/03/2024SE |
| K231657 | AGILON® XO Shoulder Replacement SystemKWT · Traditional | 02/16/2024SE |
| K232371 | Actinia® hip stemsLZO · Traditional | 10/19/2023SE |
| K223103 | BethaLoc® stem cementless HALZO · Traditional | 06/20/2023SE |
Questions and answers
When was MUTARS Cemented Femoral Stems cleared by the FDA?
MUTARS Cemented Femoral Stems (K200045) received a 510(k) decision of Substantially Equivalent on October 16, 2020, 282 days after the submission was received.
What is the product code of K200045?
The FDA product code is MEH – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, a Class II (moderate risk) device regulated under 21 CFR 888.3353.