510(k) · Cleared
Recalled · Class II · 2015Depuy Attune Knee System - Cementless CR and PS Femoral Componenets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy (Ireland) · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Feb 13, 2015 as substantially equivalent to K101433 (DePuy Orthopaedics, Inc., 2010) and 2 other predicates after a 312-day review. Its family tree reaches back 5 generations to 1994. 3 later devices descend from it. It has been recalled 10 times.
- Decided
- Feb 13, 2015
- Review
- 312 days
- Class
- Class II
- Product code
- MBH
- Recalls
- 10
- Predicates
- 3
Its longest line of descent runs back 5 generations to K943462 (1994). 16 ancestors in all, the oldest K922620 (1992). 3 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 4 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
- 3 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
- 2 generations backK101433 Depuy Attune Knee SystemDePuy Orthopaedics, Inc. · 2010
- 1 generation backK111433 Depuy Sttune (TM) PS Knee SystemDePuy Orthopaedics, Inc. · 2011 · Recalled
- This deviceK140881 Depuy Attune Knee System - Cementless CR and PS Femoral ComponenetsDepuy (Ireland) · 2015
- Descendant · cites it directly · 0 of its ownK261458 ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC · 2026
- Descendant · cites it directly · 0 of its ownK233980 ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb…Depuy Ireland UC · 2024
- Descendant · cites it directly · 0 of its ownK201347 DePuy ATTUNE™ Total Knee SystemDePuy Orthopaedics, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See all- K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC · 2026 · cites it directly0descendants
- K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System…Depuy Ireland UC · 2024 · cites it directly0descendants
- K201347DePuy ATTUNE™ Total Knee SystemDePuy Orthopaedics, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K943462 | Darwin Knee System | Johnson & Johnson Professionals, Inc. | 1994 | 8 |
| −4 | K033272 | Depuy Sigma Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | 51 |
| −3 | K040166 | Depuy Sigma XLK Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | — |
| −2 | K101433 | Depuy Attune Knee System | DePuy Orthopaedics, Inc. | 2010 | — |
| −1 | K111433 | Depuy Sttune (TM) PS Knee System | DePuy Orthopaedics, Inc. | 2011 | 1 |
| 0 (this device) | K140881 | Depuy Attune Knee System - Cementless CR and PS Femoral Componenets | Depuy (Ireland) | 2015 | — |
| +1 | K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee System | DePuy Ireland UC | 2026 | — |
| +1 | K233980 | ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation… | Depuy Ireland UC | 2024 | — |
| +1 | K201347 | DePuy ATTUNE™ Total Knee System | DePuy Orthopaedics, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 MBH? 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 MBH device
- #1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 4…em, are substantially equivalent to currently marketed devices including: • ATTUNE Knee System – CR Femoral Components, K101433 • ATTUNE Knee System – PS Femoral Components, K111433 • SIGMA CR Porocoat F… | 2010 |
| * | K111433 | Depuy Sttune (TM) PS Knee SystemSummary page 4…ices including: • ATTUNE Knee System – CR Femoral Components, K101433 • ATTUNE Knee System – PS Femoral Components, K111433 • SIGMA CR Porocoat Femoral Components, K062654 Device Description: The ATTUNE Cementless cruciate… | 2011 |
| * | K062654 | Depuy Sigma Cruciate Retaining Porocoat Femoral ComponentsSummary page 4…l Components, K101433 • ATTUNE Knee System – PS Femoral Components, K111433 • SIGMA CR Porocoat Femoral Components, K062654 Device Description: The ATTUNE Cementless cruciate retaining (CR) and posterior stabilized (PS) femora… | 2006 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 12, 2015 | Class II | Z-2145-2015 | Device Design | Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from… |
| Jun 12, 2015 | Class II | Z-2139-2015 | Device Design | Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from… |
| Jun 12, 2015 | Class II | Z-2141-2015 | Device Design | Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from… |
| Jun 12, 2015 | Class II | Z-2146-2015 | Device Design | Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from… |
| Jun 12, 2015 | Class II | Z-2143-2015 | Device Design | Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from… |
| Jun 12, 2015 | Class II | Z-2140-2015 | Device Design | Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from… |
| Jun 12, 2015 | Class II | Z-2144-2015 | Device Design | Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from… |
| Jun 12, 2015 | Class II | Z-2138-2015 | Device Design | Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from… |
| Jun 12, 2015 | Class II | Z-2137-2015 | Device Design | Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from… |
| Jun 12, 2015 | Class II | Z-2142-2015 | Device Design | Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from… |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 8 of the 16 ancestors have a recall of any class.
- Of its descendants, K261458 (DePuy Ireland UC, 2026) has gone furthest, with 0 descendants of its own.
- 14 other devices also cite its predicate K101433.
How does its category compare?
All MBH devicesMBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MBH
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBH
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBH
1in 2024
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · MBH
1,561in 2025
MAUDE reports naming product code MBH, 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 | 10 | 59 | 0 | 27 |
| 2008 | 3 | 70 | 0 | 21 |
| 2009 | 3 | 209 | 2 | 89 |
| 2010 | 4 | 84 | 0 | 121 |
| 2011 | 5 | 84 | 15 | 247 |
| 2012 | 5 | 90 | 1 (1) | 370 |
| 2013 | 6 | 138 | 4 (4) | 308 |
| 2014 | 9 | 114 | 0 | 385 |
| 2015 | 8 | 100 | 0 | 955 |
| 2016 | 4 | 74 | 1 | 1,034 |
| 2017 | 4 | 115 | 9 | 1,007 |
| 2018 | 6 | 89 | 1 | 1,191 |
| 2019 | 1 | — | 1 | 1,394 |
| 2020 | 7 | 112 | 2 | 1,089 |
| 2021 | 6 | 48 | 0 | 1,539 |
| 2022 | 7 | 57 | 0 | 1,261 |
| 2023 | 6 | 94 | 2 | 1,263 |
| 2024 | 10 | 84 | 1 | 1,497 |
| 2025 | 8 | 98 | 0 | 1,561 |
| 2026 | 7 | 153 | 4 | — |
What is it indicated for?
The ATTUNE Cementless CR and PS Femoral Components are intended for cementless use within the ATTUNE 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 (provided that adequate bone is present).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140881: Depuy Attune Knee System - Cementless CR and PS Femoral Componenets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140881
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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