Link Cementless Screw-In Acetabular Cup
FDA 510(k) K843950 · Waldemar Link GmbH & Co. KG
510(k) numberK843950
Submission
- Device name
- Link Cementless Screw-In Acetabular Cup
- Applicant
- Waldemar Link GmbH & Co. KG
E. Hanover, NJ, US - Received
- October 9, 1984
- Decision date
- June 3, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KWA – Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 888.3330
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K122778 | Profemur Z Revision Hip StemKWA · Special | Wrightmedicaltechnologyinc | 10/11/2012SE |
| K121544 | Dynasty Biofoam ShellKWA · Traditional | Wrightmedicaltechnologyinc | 07/30/2012SE |
| K113271 | Metal-On-Metal Hip Systems-Additional ContraindicationsKWA · Traditional | Biomet Manufacturing, Inc. | 05/18/2012SE |
| K113322 | Conserve Thin ShellKWA · Special | Wrightmedicaltechnologyinc | 02/03/2012SE |
| K112080 | Preserve Hip StemKWA · Special | Wrightmedicaltechnologyinc | 12/28/2011SE |
| K112150 | Profemur Gladiator Ha Hip StemKWA · Traditional | Wrightmedicaltechnologyinc | 11/23/2011SE |
| K113019 | Profemur XM Wingless Distal Centralizer, Perfecta Distal CentralizerKWA · Special | Wrightmedicaltechnologyinc | 11/10/2011SE |
| K111910 | Gladiator Hip StemKWA · Traditional | Wrightmedicaltechnologyinc | 10/14/2011SE |
| K110836 | CLS Brevius Stem with Kinectiv TechnologyKWA · Traditional | Zimmer GmbH | 10/07/2011SE |
| K110400 | Taperloc Complete Microplasty StemKWA · Traditional | Biomet Manufacturing Corp | 09/30/2011SE |
More from Biomet Manufacturing Corp
| 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 Link Cementless Screw-In Acetabular Cup cleared by the FDA?
Link Cementless Screw-In Acetabular Cup (K843950) received a 510(k) decision of Substantially Equivalent on June 3, 1985, 237 days after the submission was received.
What is the product code of K843950?
The FDA product code is KWA – Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component), a Class III (high risk) device regulated under 21 CFR 888.3330.