510(k) · Cleared
Recalled · Class II · 2024ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP
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 Jan 18, 2022 as substantially equivalent to K202194 (Depuy Ireland UC, 2020) after a 46-day review. Its family tree reaches back 7 generations to 1995. It has been recalled once.
- Decided
- Jan 18, 2022
- Review
- 46 days
- Class
- Class II
- Product code
- MBH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K933785 (1995). 30 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 deviceK213781 ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DPDepuy Ireland UC · 2022
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) | K213781 | ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP | Depuy Ireland UC | 2022 | — |
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 |
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 20.0 · 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? (1)
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 |
|---|---|---|---|
| * | K202194 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized…Summary page 4…to which equivalence is claimed Primary Predicate for ATTUNE Porous Fixed Bearing Tibial Base: ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP Technology — K202194 — Cleared 11/25/2020 Reason for 510(k) submission Update Tensile Mechanical Properties In-Process Limits. Device description… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 22 of the 30 ancestors have a recall of any class.
- 3 other devices also cite its predicate K202194.
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. 2022, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213781 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213781: ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213781
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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