MobileLink Acetabular Cup System - Line Extension (Multiple)
FDA 510(k) K241636 · Waldemar Link GmbH & Co. KG
510(k) numberK241636
Submission
- Device name
- MobileLink Acetabular Cup System - Line Extension (Multiple)
- Applicant
- Waldemar Link GmbH & Co. KG
Norderstedt, DE - Received
- June 6, 2024
- Decision date
- November 8, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LPH – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3358
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LPH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253630 | Mpact 3D Metal FoamLPH · Traditional | Medacta International S.A. | 08/28/2026SE |
| K254043 | TRIVANCE Hip StemLPH · Traditional | Globus Medical, Inc. | 08/04/2026SE |
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…LPH · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 07/10/2026SE |
| K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…LPH · Traditional | Nextstep Arthopedix, LLC | 06/05/2026SE |
| K251270 | Taperloc® Complete Hip StemLPH · Traditional | Biomet, Inc. | 05/19/2026SE |
| K252623 | G7® Revision Acetabular SystemLPH · Traditional | Zimmer, Inc. | 02/04/2026SE |
| K251043 | Mpact 3D Metal Implants Extension DMLS TechnologyLPH · Traditional | Medacta International S.A. | 01/28/2026SE |
| K252067 | Velora Acetabular SystemLPH · Traditional | Restor3D, Inc. | 12/05/2025SE |
| K252846 | TaperSet Hip SystemLPH · Special | Shalby Advanced Technologies, Inc. Dba Consensus… | 11/20/2025SE |
| K251833 | EMPOWR Acetabular® Liner ExtensionLPH · Traditional | Encore Medical L.P. | 11/12/2025SE |
More from Encore Medical L.P.
| 510(k) | Device | Decision |
|---|---|---|
| K261009 | MobileLink Acetabular Cup System 40mm ID Inserts (various)LZO · Traditional | 07/06/2026SE |
| K250375 | Allure Hip Stem and Intramedullary PlugsMEH · Traditional | 11/05/2025SE |
| K243927 | MobileLink Acetabular Cup System - inhouse coatingsLZO · Traditional | 05/16/2025SE |
| K231445 | LINK Embrace Shoulder System - Reverse ConfigurationPHX · Traditional | 11/16/2023SE |
| K222066 | LINK MobileLink Acetabular Cup SystemLPH · Traditional | 04/14/2023SE |
| K230471 | LinkSymphoKnee Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceJWH · Special | 03/21/2023SE |
| K213770 | SP-CL Hip Stem and LCU Hip SystemLZO · Traditional | 09/13/2022SE |
| K221794 | Vario-Cup SystemKWY · Special | 07/20/2022SE |
| K211567 | BiMobile Instruments (for BiMobile Dual Mobility System)LZO · Special | 06/03/2022SE |
| K220628 | LINK Endo-Model EVO Knee SystemKRO · Traditional | 05/03/2022SE |
Questions and answers
When was MobileLink Acetabular Cup System - Line Extension (Multiple) cleared by the FDA?
MobileLink Acetabular Cup System - Line Extension (Multiple) (K241636) received a 510(k) decision of Substantially Equivalent on November 8, 2024, 155 days after the submission was received.
What is the product code of K241636?
The FDA product code is LPH – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3358.