Betacone Hip Prosthesis System
FDA 510(k) K051826 · Waldemar Link GmbH & Co. KG
510(k) numberK051826
Submission
- Device name
- Betacone Hip Prosthesis System
- Applicant
- Waldemar Link GmbH & Co. KG
Philadelphia, PA, US - Received
- July 5, 2005
- Decision date
- November 18, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LWJ – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LWJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K120595 | Unisyn Plus Hip StemLWJ · Traditional | Consensus Orthopedics, Inc. | 10/12/2012SE |
| K103518 | Trinity Acetabular SystemLWJ · Traditional | Corin USA | 03/09/2011SE |
| K090764 | Novation CFS Press-Fit and Cemented StemsLWJ · Special | Exactech, Inc. | 04/21/2009SE |
| K082146 | Metha Short Stem Hip System XL Femoral HeadLWJ · Special | Aesculap Implant Systems, Inc. | 09/09/2008SE |
| K070061 | 36MM Cocr Femoral Head and 36MM Acetabular InsertLWJ · Special | Hayes Medical, Inc. | 01/31/2007SE |
| K062978 | U2 Hip Stem, Ti Plasma SprayLWJ · Traditional | United Orthopedic Corp. | 01/16/2007SE |
| K062383 | Unisyn Ha Plasma Modular HipLWJ · Special | Hayes Medical, Inc. | 12/21/2006SE |
| K061699 | ExciaLWJ · Special | Aesculap, Inc. | 08/18/2006SE |
| K050262 | U2 Acetabular ComponentLWJ · Traditional | United Orthopedic Corp. | 08/15/2005SE |
| K042344 | Excia Total Hip SystemLWJ · Abbreviated | Aesculap, Inc. | 03/16/2005SE |
More from Aesculap, 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 |
| K211567 | BiMobile Instruments (for BiMobile Dual Mobility System)LZO · Special | 06/03/2022SE |
Questions and answers
When was Betacone Hip Prosthesis System cleared by the FDA?
Betacone Hip Prosthesis System (K051826) received a 510(k) decision of Substantially Equivalent on November 18, 2005, 136 days after the submission was received.
What is the product code of K051826?
The FDA product code is LWJ – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3360.