510(k) · Cleared
Recalled · Class II · 2024ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Ireland UC · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Nov 25, 2020 as substantially equivalent to K101433 (DePuy Orthopaedics, Inc., 2010) and 3 other predicates after a 112-day review. Its family tree reaches back 6 generations to 1995. 4 later devices descend from it. It has been recalled once.
- Decided
- Nov 25, 2020
- Review
- 112 days
- Class
- Class II
- Product code
- MBH
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 6 generations to K933785 (1995). 29 ancestors in all, the oldest K910500 (1991). 4 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 5 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- 4 generations backK031061 Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc. · 2003 · Recalled
- 3 generations backK072160 Nexgen Trabecular Metal Tibial TrayZimmer, Inc. · 2007 · Recalled
- 2 generations backK123486 Triathlon Tritanium Tibial BaseplateStryker · 2013 · Recalled
- 1 generation backK132624 Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics · 2013 · Recalled
- This deviceK202194 ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella…Depuy Ireland UC · 2020
- Descendant · cites it directly · 1 of its ownK232303 ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella…Depuy Ireland UC · 2023 · Recalled
- 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 ownK240678 ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella…Depuy Ireland UC · 2024
- Descendant · cites it directly · 0 of its ownK213781 ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DPDepuy Ireland UC · 2022 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K232303ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC · 2023 · cites it directly1descendant
- K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC · 2026 · cites it directly0descendants
- K240678ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC · 2024 · cites it directly0descendants
- K213781ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DPDepuy Ireland UC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933785 | Next Generation Knee System | Zimmer, Inc. | 1995 | 83 |
| −5 | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | Zimmer, Inc. | 2002 | 6 |
| −4 | K031061 | Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components | Zimmer, Inc. | 2003 | 24 |
| −3 | K072160 | Nexgen Trabecular Metal Tibial Tray | Zimmer, Inc. | 2007 | 1 |
| −2 | K123486 | Triathlon Tritanium Tibial Baseplate | Stryker | 2013 | 7 |
| −1 | K132624 | Triathlon Tritanium Metal-Backed Patella | Stryker Orthopaedics | 2013 | 1 |
| 0 (this device) | K202194 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and… | Depuy Ireland UC | 2020 | — |
| +1 | K232303 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and… | Depuy Ireland UC | 2023 | 1 |
| +1 | K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee System | DePuy Ireland UC | 2026 | — |
| +1 | K240678 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and… | Depuy Ireland UC | 2024 | — |
| +1 | K213781 | ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP | Depuy Ireland UC | 2022 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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? (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 4…Secondary: JWH Primary Predicate for ATTUNE Porous Fixed Bearing Tibial Base: DePuy ATTUNE Knee System, K101433 Primary Predicate for ATTUNE Porous Medialized Dome Patella & Med… | 2010 |
| * | K103756 | Depuy Attune Total Knee SystemSummary page 4…edialized Dome Patella & Medialized Anatomic Patella: DePuy ATTUNE Medialized Dome and Anatomic Patellae, K103756 Legally marketed device(s) to Secondary Predicate for ATTUNE Porous Fixed Bearing Tibial Base: which equivalence is claimed… | 2011 |
| * | K123486 | Triathlon Tritanium Tibial BaseplateSummary page 4…56 Legally marketed device(s) to Secondary Predicate for ATTUNE Porous Fixed Bearing Tibial Base: which equivalence is claimed Triathlon Tritanium Tibial Baseplate, K123486 Secondary Predicate for ATTUNE Porous Medialized Dome Patella & M… | 2013 |
| * | K132624 | Triathlon Tritanium Metal-Backed PatellaSummary page 4…E Porous Medialized Dome Patella & Medialized Anatomic Patella: Triathlon Tritanium Metal-Backed Patella, K132624 Reference Devices: DePuy ATTUNE Cementless CR & PS Femoral Compon… | 2013 |
| † | K140881 | Depuy Attune Knee System - Cementless CR and PS Femoral Componenets | 2015 |
| † | K160700 | ATTUNE Revision Knee System | 2016 |
| † | K201347 | DePuy ATTUNE™ Total Knee System | 2020 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232303 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized… | 2023 | 1 |
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee System | 2026 | 0 |
| K240678 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized… | 2024 | 0 |
| K213781 | ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 12, 2024 | Class II | Z-1456-2024 | Process change control | Product incorrectly labelled. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 21 of the 29 ancestors have a recall of any class.
- Of its descendants, K232303 (Depuy Ireland UC, 2023) has gone furthest, with 1 descendant 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. 2020, 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 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 as stated in the FDA summary.
https://510kreport.com/device/K202194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202194: ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202194
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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