DePuy ATTUNE Total Knee System
FDA 510(k) K242665 · Depuy Orthopedics, Inc.
Submission
- Device name
- DePuy ATTUNE Total Knee System
- Applicant
- Depuy Orthopedics, Inc.
Warsaw, IN, US - Received
- September 4, 2024
- Decision date
- November 1, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OIY – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3560
- Specialty
- Orthopedic
- Implant
- Yes
Indicated for: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. For cemented use.
Other 510(k)s with product code OIY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252887 | DePuy ATTUNE Knee SystemOIY · Traditional | DePuy Orthopaedics, Inc. | 05/22/2026SE |
| K201347 | DePuy ATTUNE Total Knee SystemOIY · Special | DePuy Orthopaedics, Inc. | 06/18/2020SE |
| K120038 | A200 Knee SystemOIY · Traditional | Renovis Surgical Technologies, LLC | 02/14/2013SE |
| K121727 | Movation Knee SystemOIY · Special | Encore Medical L.P. | 08/15/2012SE |
| K113756 | Highly Cross Linked Ve Central Peg Patella Highly Cross Linked Ve Tri-Peg Patella Highly…OIY · Special | Encore Medical L.P. | 03/14/2012SE |
| K111433 | Depuy Sttune (TM) PS Knee SystemOIY · Traditional | DePuy Orthopaedics, Inc. | 08/30/2011SE |
| K103756 | Depuy Attune Total Knee SystemOIY · Traditional | DePuy Orthopaedics, Inc. | 03/15/2011SE |
| K103223 | Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsOIY · Traditional | Encore Medical L.P. | 12/21/2010SE |
| K101433 | Depuy Attune Knee SystemOIY · Traditional | DePuy Orthopaedics, Inc. | 12/10/2010SE |
| K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712OIY · Traditional | Encore Medical L.P. | 09/28/2010SE |
Questions and answers
When was DePuy ATTUNE Total Knee System cleared by the FDA?
DePuy ATTUNE Total Knee System (K242665) received a 510(k) decision of Substantially Equivalent on November 1, 2024, 58 days after the submission was received.
What is the product code of K242665?
The FDA product code is OIY – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive, a Class II (moderate risk) device regulated under 21 CFR 888.3560.