Oxford Unicompartmental Knee Femoral Component
FDA 510(k) K011138 · Biomet, Inc.
510(k) numberK011138
Submission
- Device name
- Oxford Unicompartmental Knee Femoral Component
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- April 13, 2001
- Decision date
- July 10, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRY – Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3530
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K193549 | SIGMA High Performance (HP) Partial Knee SystemHRY · Traditional | Depuy Ireland UC | 04/16/2020SE |
| K190633 | NanoOrtho NanoKnee® SystemHRY · Traditional | Nanoortho, LLC | 12/20/2019SE |
| K152631 | MPO Total Knee Systems MR LabelingHRY · Traditional | Microport Orthopedics, Inc. | 03/23/2016SE |
| K150410 | Restoris Porous Partial Knee SystemHRY · Special | Mako Surgical Corporation | 03/20/2015SE |
| K133940 | Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays)HRY · Traditional | Biomet UK, Ltd. | 03/28/2014SE |
| K131167 | UnivationHRY · Traditional | Aesculap Implant Systems, LLC | 10/17/2013SE |
| K122277 | Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays A-F) Ixford…HRY · Traditional | Biomet Manufacturing Corp | 10/22/2012SE |
| K110415 | Signature Planner / Signature GuidesHRY · Traditional | Materialise NV | 05/16/2011SE |
| K100973 | Evolution Unicondylar Knee SystemHRY · Traditional | Wrightmedicaltechnologyinc | 08/10/2010SE |
| K082567 | Stryker Compartmental Knee System Line ExtensionHRY · Special | Howmedica Osteonics Corp. | 10/03/2008SE |
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| K213287 | StageOne Knee Cement Spacer MoldsMBB · Traditional | 09/02/2022SE |
| K212431 | Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveJDG · Traditional | 02/07/2022SE |
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| K210192 | A.L.P.S. Clavicle Plating SystemHRS · Special | 02/19/2021SE |
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Questions and answers
When was Oxford Unicompartmental Knee Femoral Component cleared by the FDA?
Oxford Unicompartmental Knee Femoral Component (K011138) received a 510(k) decision of Substantially Equivalent on July 10, 2001, 88 days after the submission was received.
What is the product code of K011138?
The FDA product code is HRY – Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3530.