510(k) · Cleared
ClearedDePuy ATTUNE™ Total Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Cleared on Jun 18, 2020 as substantially equivalent to K101433 (DePuy Orthopaedics, Inc., 2010) and 3 other predicates after a 28-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Jun 18, 2020
- Review
- 28 days
- Class
- Class II
- Product code
- OIY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K943462 (1994). 19 ancestors in all, the oldest K910500 (1991). No later device cites it as a predicate yet.
- Root · 6 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 5 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
- 4 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
- 3 generations backK101433 Depuy Attune Knee SystemDePuy Orthopaedics, Inc. · 2010
- 2 generations backK111433 Depuy Sttune (TM) PS Knee SystemDePuy Orthopaedics, Inc. · 2011 · Recalled
- 1 generation backK140881 Depuy Attune Knee System - Cementless CR and PS Femoral ComponenetsDepuy (Ireland) · 2015 · Recalled
- This deviceK201347 DePuy ATTUNE™ Total Knee SystemDePuy Orthopaedics, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K943462 | Darwin Knee System | Johnson & Johnson Professionals, Inc. | 1994 | 8 |
| −5 | K033272 | Depuy Sigma Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | 51 |
| −4 | K040166 | Depuy Sigma XLK Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | — |
| −3 | K101433 | Depuy Attune Knee System | DePuy Orthopaedics, Inc. | 2010 | — |
| −2 | K111433 | Depuy Sttune (TM) PS Knee System | DePuy Orthopaedics, Inc. | 2011 | 1 |
| −1 | K140881 | Depuy Attune Knee System - Cementless CR and PS Femoral Componenets | Depuy (Ireland) | 2015 | 10 |
| 0 (this device) | K201347 | DePuy ATTUNE™ Total Knee System | DePuy Orthopaedics, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OIY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OIY device
- #1 K252887 DePuy ATTUNE™ Knee Systemscore 12.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K101433 | Depuy Attune Knee SystemSummary page 5…duct Code(s) OIY, JWH, MBH Legally marketed device(s) to which Primary Predicate: equivalence is claimed DePuy ATTUNE Knee System, K101433 Reference Predicates: DePuy ATTUNE PS Knee System, K1… | 2010 |
| * | K111433 | Depuy Sttune (TM) PS Knee SystemSummary page 5…DePuy ATTUNE Knee System, K101433 Reference Predicates: DePuy ATTUNE PS Knee System, K111433 DePuy ATTUNE Medialized Dome and Anatomic Patellae Co… | 2011 |
| * | K103756 | Depuy Attune Total Knee SystemSummary page 5…ATTUNE PS Knee System, K111433 DePuy ATTUNE Medialized Dome and Anatomic Patellae Components, K103756 ATTUNE Total Knee System – Cementless CR & PS Femoral… | 2011 |
| * | K140881 | Depuy Attune Knee System - Cementless CR and PS Femoral ComponenetsSummary page 5…Components, K103756 ATTUNE Total Knee System – Cementless CR & PS Femoral Components, K140881 Reason for 510(k) The purpose of this submission is to extend the current approved shelf submission… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 9 of the 19 ancestors have a recall of any class.
- 14 other devices also cite its predicate K101433.
How does its category compare?
All OIY devicesOIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OIY
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OIY
132in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OIY
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OIY
35in 2025
MAUDE reports naming product code OIY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 4 | 132 | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 6 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 0 | — | 1 | 84 |
| 2015 | 0 | — | 1 | 282 |
| 2016 | 0 | — | 0 | 130 |
| 2017 | 0 | — | 0 | 91 |
| 2018 | 0 | — | 0 | 68 |
| 2019 | 0 | — | 0 | 78 |
| 2020 | 1 | — | 0 | 121 |
| 2021 | 0 | — | 0 | 379 |
| 2022 | 0 | — | 0 | 42 |
| 2023 | 0 | — | 0 | 40 |
| 2024 | 1 | — | 0 | 34 |
| 2025 | 0 | — | 0 | 35 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The DePuy Attune Total Knee System is intended for cemented or noncemented use as a total knee replacement system.
Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201347 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201347: DePuy ATTUNE™ Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201347
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026