DePuy ATTUNE Knee System
FDA 510(k) K252887 · DePuy Orthopaedics, Inc.
Submission
- Device name
- DePuy ATTUNE Knee System
- Applicant
- DePuy Orthopaedics, Inc.
Warsaw, IN, US - Received
- September 10, 2025
- Decision date
- May 22, 2026
- 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 |
|---|---|---|---|
| K242665 | DePuy ATTUNE Total Knee SystemOIY · Traditional | Depuy Orthopedics, Inc. | 11/01/2024SE |
| 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 |
More from Encore Medical L.P.
| 510(k) | Device | Decision |
|---|---|---|
| K262130 | ATTUNE Revision Knee SystemJWH · Traditional | 09/04/2026SE |
| K231503 | CUPTIMIZE AdvancedLLZ · Traditional | 08/22/2023SE |
| K213839 | DePuy Corail AMT Hip ProsthesisLZO · Special | 01/06/2022SE |
| K210167 | DELTA XTEND Reverse Shoulder SystemPHX · Special | 02/19/2021SE |
| K203167 | DePuy Corail AMT Hip ProsthesisLZO · Special | 11/19/2020SE |
| K202472 | ACTIS Duofix Hip ProsthesisLPH · Special | 10/21/2020SE |
| K201347 | DePuy ATTUNE Total Knee SystemOIY · Special | 06/18/2020SE |
| K193540 | TRUMATCH Personalized SolutionsJWH · Traditional | 06/16/2020SE |
| K193398 | Summit DuoFix HA CoatingMEH · Special | 02/04/2020SE |
| K192946 | DePuy Corail AMT Hip ProsthesisLZO · Special | 11/26/2019SE |
Questions and answers
When was DePuy ATTUNE Knee System cleared by the FDA?
DePuy ATTUNE Knee System (K252887) received a 510(k) decision of Substantially Equivalent on May 22, 2026, 254 days after the submission was received.
What is the product code of K252887?
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.