Repicci Locked Keel Tibial Bearing
FDA 510(k) K030446 · Biomet, Inc.
510(k) numberK030446
Submission
- Device name
- Repicci Locked Keel Tibial Bearing
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- February 11, 2003
- Decision date
- March 6, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 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 |
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| K082567 | Stryker Compartmental Knee System Line ExtensionHRY · Special | Howmedica Osteonics Corp. | 10/03/2008SE |
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Questions and answers
When was Repicci Locked Keel Tibial Bearing cleared by the FDA?
Repicci Locked Keel Tibial Bearing (K030446) received a 510(k) decision of Substantially Equivalent on March 6, 2003, 23 days after the submission was received.
What is the product code of K030446?
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.