510(k) · Cleared
ClearedATTUNE Total Knee System; ATTUNE Cementless Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Ireland UC · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jun 25, 2026 as substantially equivalent to K111433 (DePuy Orthopaedics, Inc., 2011) and 3 other predicates after a 55-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Jun 25, 2026
- Review
- 55 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K933785 (1995). 36 ancestors in all, the oldest K910500 (1991). No later device cites it as a predicate yet.
- Root · 7 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 6 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- 5 generations backK031061 Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc. · 2003 · Recalled
- 4 generations backK072160 Nexgen Trabecular Metal Tibial TrayZimmer, Inc. · 2007 · Recalled
- 3 generations backK123486 Triathlon Tritanium Tibial BaseplateStryker · 2013 · Recalled
- 2 generations backK132624 Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics · 2013 · Recalled
- 1 generation backK202194 ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella…Depuy Ireland UC · 2020 · Recalled
- This deviceK261458 ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K933785 | Next Generation Knee System | Zimmer, Inc. | 1995 | 83 |
| −6 | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | Zimmer, Inc. | 2002 | 6 |
| −5 | K031061 | Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components | Zimmer, Inc. | 2003 | 24 |
| −4 | K072160 | Nexgen Trabecular Metal Tibial Tray | Zimmer, Inc. | 2007 | 1 |
| −3 | K123486 | Triathlon Tritanium Tibial Baseplate | Stryker | 2013 | 7 |
| −2 | K132624 | Triathlon Tritanium Metal-Backed Patella | Stryker Orthopaedics | 2013 | 1 |
| −1 | K202194 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and… | Depuy Ireland UC | 2020 | 1 |
| 0 (this device) | K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee System | DePuy Ireland UC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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 JWH? 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 JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K111433 | Depuy Sttune (TM) PS Knee SystemSummary page 5…e, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Legally marketed device(s) Primary Predicate: K111433 - DePuy Attune TM Knee System to which equivalence is Secondary Predicate: K170806 – ATTUNE Cemented T… | 2011 |
| * | K170806 | ATTUNE Cemented Tibial Base, Fixed BearingSummary page 5…er + Additive Legally marketed device(s) Primary Predicate: K111433 - DePuy Attune TM Knee System to which equivalence is Secondary Predicate: K170806 – ATTUNE Cemented Tibial Base, claimed Fixed Bearing… | 2017 |
| * | K140881 | Depuy Attune Knee System - Cementless CR and PS Femoral ComponenetsSummary page 8…JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Legally marketed device(s) Primary Predicate: K140881 - ATTUNETM Knee System- Cementless to which equivalence is CR and PS Femoral Components claimed Sec… | 2015 |
| * | K202194 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized…Summary page 8…ary Predicate: K140881 - ATTUNETM Knee System- Cementless to which equivalence is CR and PS Femoral Components claimed Secondary Predicate: K202194 – ATTUNETM Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic… | 2020 |
| † | K233980 | ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System… | 2024 |
| † | K232303 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized… | 2023 |
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 31 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 25 of the 36 ancestors have a recall of any class.
- 7 other devices also cite its predicate K111433.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, 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 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
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. 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…
Read the full statement (149 words)
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.
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, or a failed previous implant (provided that adequate bone is present).
The ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are intended for cementless use within the ATTUNE® Total Knee Replacement System. Porous coated implants may be used with or without cement.
Candidates for total knee replacement include patients with a severely painful and/or impaired knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261458: ATTUNE Total Knee System; ATTUNE Cementless Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261458
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026