BiMobile Instruments (for BiMobile Dual Mobility System)
FDA 510(k) K211567 · Waldemar Link GmbH & Co. KG
510(k) numberK211567
Submission
- Device name
- BiMobile Instruments (for BiMobile Dual Mobility System)
- Applicant
- Waldemar Link GmbH & Co. KG
Norderstedt, DE - Received
- May 21, 2021
- Decision date
- June 3, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3353
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LZO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253948 | Momentum Acetabular Cup SystemLZO · Traditional | United Orthopedic Corporation | 09/02/2026SE |
| K261009 | MobileLink Acetabular Cup System 40mm ID Inserts (various)LZO · Traditional | Waldemar Link GmbH & Co. KG | 07/06/2026SE |
| K260831 | Z1 Hip SystemLZO · Traditional | Zimmer, Inc. | 06/16/2026SE |
| K260182 | Avenir® Müller Stem; Avenir Complete Hip SystemLZO · Traditional | Zimmer, Inc. | 04/27/2026SE |
| K260037 | implantcast Packaging System UpdateLZO · Traditional | Implantcast GmbH | 03/30/2026SE |
| K252401 | implaFit® short stemsLZO · Traditional | Implantcast GmbH | 03/12/2026SE |
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)LZO · Traditional | Maxx Orthopedics, Inc. | 01/15/2026SE |
| K250450 | Coated hip implantsLZO · Traditional | Medacta International S.A. | 09/19/2025SE |
| K243021 | Longboard Revision Hip StemLZO · Traditional | Signature Orthopaedics Pty, Ltd. | 08/07/2025SE |
| K251906 | Z1 Hip SystemLZO · Special | Zimmer, Inc. | 07/18/2025SE |
More from Zimmer, Inc.
| 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 |
| K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple)LPH · Traditional | 11/08/2024SE |
| 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 |
| K220628 | LINK Endo-Model EVO Knee SystemKRO · Traditional | 05/03/2022SE |
Questions and answers
When was BiMobile Instruments (for BiMobile Dual Mobility System) cleared by the FDA?
BiMobile Instruments (for BiMobile Dual Mobility System) (K211567) received a 510(k) decision of Substantially Equivalent on June 3, 2022, 378 days after the submission was received.
What is the product code of K211567?
The FDA product code is LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3353.