Xr-Series Bi-Metric Femoral Components
FDA 510(k) K052089 · Biomet Manufacturing, Inc.
510(k) numberK052089
Submission
- Device name
- Xr-Series Bi-Metric Femoral Components
- Applicant
- Biomet Manufacturing, Inc.
Warsaw, IN, US - Received
- August 2, 2005
- Decision date
- February 17, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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|---|---|---|---|
| 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 |
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| K211729 | Comprehensive® Convertible Glenoid - Vivacit-E LinerPHX · Traditional | 11/04/2021SE |
| K202232 | Comprehensive Vault Reconstruction SystemPHX · Traditional | 02/19/2021SE |
| K193038 | Comprehensive Shoulder SystemMBF · Traditional | 10/28/2020SE |
| K182516 | Comprehensive Nano Stemless ShoulderPKC · Traditional | 04/22/2019SE |
| K181611 | Comprehensive Reverse Shoulder SystemPHX · Traditional | 09/24/2018SE |
| K173411 | Comprehensive Segmental Revision System (SRS)PHX · Traditional | 02/08/2018SE |
| K172502 | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…PHX · Traditional | 01/03/2018SE |
| K163651 | ExpressBraid Graft ManipulationGAT · Traditional | 02/17/2017SE |
Questions and answers
When was Xr-Series Bi-Metric Femoral Components cleared by the FDA?
Xr-Series Bi-Metric Femoral Components (K052089) received a 510(k) decision of Substantially Equivalent on February 17, 2006, 199 days after the submission was received.
What is the product code of K052089?
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.