510(k) · Cleared
Recalled · Class II · 2021ATTUNE Cemented Tibial Base, Fixed Bearing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy (Ireland) · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jun 15, 2017 as substantially equivalent to K101433 (DePuy Orthopaedics, Inc., 2010) and 1 other predicate after a 90-day review. Its family tree reaches back 4 generations to 1994. 2 later devices descend from it. It has been recalled once.
- Decided
- Jun 15, 2017
- Review
- 90 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K943462 (1994). 11 ancestors in all, the oldest K922620 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 3 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
- 2 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
- 1 generation backK101433 Depuy Attune Knee SystemDePuy Orthopaedics, Inc. · 2010
- This deviceK170806 ATTUNE Cemented Tibial Base, Fixed BearingDepuy (Ireland) · 2017
- 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
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943462 | Darwin Knee System | Johnson & Johnson Professionals, Inc. | 1994 | 8 |
| −3 | K033272 | Depuy Sigma Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | 51 |
| −2 | K040166 | Depuy Sigma XLK Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | — |
| −1 | K101433 | Depuy Attune Knee System | DePuy Orthopaedics, Inc. | 2010 | — |
| 0 (this device) | K170806 | ATTUNE Cemented Tibial Base, Fixed Bearing | Depuy (Ireland) | 2017 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (2)
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…panel 87 Orthopedics Regulation 21 CFR 888.3560 Product Code(s) OIY, JWH Legally marketed Primary Predicate: device(s) to which K101433: DePuy ATTUNE Knee System equivalence is claimed Reference Predicate: K032151: Sigma Co-Cr Tibial Tray… | 2010 |
| * | K032151 | Depuy Sigma Tibial Inserts and CO-CR Tibial TraysSummary page 4…lly marketed Primary Predicate: device(s) to which K101433: DePuy ATTUNE Knee System equivalence is claimed Reference Predicate: K032151: Sigma Co-Cr Tibial Trays Reason for 510(k) Addition of a new Cemented Tibial Base component to the ATTUNE submission… | 2003 |
What descends from it? (2)
2 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 |
|---|---|---|---|---|
| Feb 22, 2021 | Class II | Z-1314-2021 | Packaging change control | Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
- 6 of the 11 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 JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170806 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170806: ATTUNE Cemented Tibial Base, Fixed Bearing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170806
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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