Depuy Sttune (TM) PS Knee System
FDA 510(k) K111433 · DePuy Orthopaedics, Inc.
Submission
- Device name
- Depuy Sttune (TM) PS Knee System
- Applicant
- DePuy Orthopaedics, Inc.
Warsaw, IN, US - Received
- May 23, 2011
- Decision date
- August 30, 2011
- 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.
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|---|---|---|---|
| K252887 | DePuy ATTUNE Knee SystemOIY · Traditional | DePuy Orthopaedics, Inc. | 05/22/2026SE |
| 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 |
| 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 |
| K252887 | DePuy ATTUNE Knee SystemOIY · Traditional | 05/22/2026SE |
| 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 |
Questions and answers
When was Depuy Sttune (TM) PS Knee System cleared by the FDA?
Depuy Sttune (TM) PS Knee System (K111433) received a 510(k) decision of Substantially Equivalent on August 30, 2011, 99 days after the submission was received.
What is the product code of K111433?
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.