Howmedica Kinematic II Tibial Wedge
FDA 510(k) K842367 · Howmedica Corp.
510(k) numberK842367
Submission
- Device name
- Howmedica Kinematic II Tibial Wedge
- Applicant
- Howmedica Corp.
Mchenry, IL, US - Received
- June 15, 1984
- Decision date
- August 17, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
More from Howmedica Osteonics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K984251 | Xia Spine SystemKWQ · Traditional | 02/24/1999SE |
| K984202 | Howmedica Humeral Intercalary SystemHSD · Traditional | 02/05/1999SE |
| K984305 | Zeta Multizone Locking Nail SystemHSB · Traditional | 02/01/1999SE |
| K983885 | Burr Hole Covers, Craniomaxillofacial PlatesJEY · Traditional | 01/29/1999SE |
| K983528 | Micro Dynamic MeshJEY · Traditional | 12/23/1998SE |
| K983404 | Type 3 Femoral ComponentsLZO · Traditional | 12/22/1998SE |
| K980926 | Duration II Acetabular Components-Ethylene Oxide SterilizationJDI · Traditional | 12/16/1998SE |
| K980925 | Duration II Tibial Inserts-Ethylene Oxide SterilizationJWH · Traditional | 12/16/1998SE |
| K980632 | Duration II Tibial Inserts - Gas Plasma SterilizationJWH · Traditional | 12/11/1998SE |
| K980626 | Duration II Acetabular Components-Gas Plasma SterilizationJDI · Traditional | 12/11/1998SE |
Questions and answers
When was Howmedica Kinematic II Tibial Wedge cleared by the FDA?
Howmedica Kinematic II Tibial Wedge (K842367) received a 510(k) decision of Substantially Equivalent on August 17, 1984, 63 days after the submission was received.
What is the product code of K842367?
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.