Keane Uni Knee System
FDA 510(k) K910807 · Depuy, Inc.
510(k) numberK910807
Submission
- Device name
- Keane Uni Knee System
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- February 26, 1991
- Decision date
- June 27, 1991
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- HSX – Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3520
- Specialty
- Orthopedic
- Implant
- Yes
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| K242746 | OvertureTi Knee Resurfacing SystemTMHSX · Special | Overture Orthopaedics | 10/07/2024SE |
| K232114 | TRIBRID® Unicompartmental Knee SystemHSX · Traditional | Kyocera Medical Technologies, Inc. | 04/04/2024SE |
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| K040544 | Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066, 1599-11-044 to -062…LPH · Traditional | 05/28/2004SE |
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| K033329 | Depuy Ace Universal and Troch Entry Femoral Nail SystemsHSB · Traditional | 11/14/2003SE |
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| K020541 | Agility Ankle Revision ProsthesisHSN · Traditional | 05/20/2002SE |
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Questions and answers
When was Keane Uni Knee System cleared by the FDA?
Keane Uni Knee System (K910807) received a 510(k) decision of Substantially Equivalent for Some Indications on June 27, 1991, 121 days after the submission was received.
What is the product code of K910807?
The FDA product code is HSX – Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3520.