Natural-Knee II Unicompartmental Knee System
FDA 510(k) K033810 · Centerpulse Orthopedics, Inc.
510(k) numberK033810
Submission
- Device name
- Natural-Knee II Unicompartmental Knee System
- Applicant
- Centerpulse Orthopedics, Inc.
Austin, TX, US - Received
- December 8, 2003
- Decision date
- March 5, 2004
- 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 |
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| 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 |
More from Howmedica Osteonics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K033943 | Alpha Metasul 28MM and 32MM Acetabular Inserts, Standard and HoodedKWA · Traditional | 10/18/2004SE |
| K033634 | Epsilon Metasul 32MM Acetabular Inserts, Standard and HoodedKWA · Traditional | 09/15/2004SE |
| K040947 | Durasul BipolarKWY · Traditional | 08/27/2004SE |
| K033664 | Modification to Alloclassic Zweymuller SL Offset Femoral StemLZO · Special | 12/17/2003SE |
| K032348 | Converge Reti-Lock Multi-Hole Reinforcement CupLZO · Traditional | 10/24/2003SE |
| K030923 | Epsilon Durasul Constrained Acetabular LinerKWZ · Traditional | 10/03/2003SE |
| K032380 | Wagner Cone ProsthesisLZO · Traditional | 09/22/2003SE |
| K031183 | Tibial Spacer for the Natural-Knee II Cemented Modular Tibial BaseplateJWH · Traditional | 07/14/2003SE |
| K030373 | Alloclassic Zweymueller Sl/Sll Femoral StemLZO · Special | 03/06/2003SE |
Questions and answers
When was Natural-Knee II Unicompartmental Knee System cleared by the FDA?
Natural-Knee II Unicompartmental Knee System (K033810) received a 510(k) decision of Substantially Equivalent on March 5, 2004, 88 days after the submission was received.
What is the product code of K033810?
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.