510(k) · Cleared
Recalled · Class II · 2026ATTUNE™ Revision Hinge Knee
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Ireland UC · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Nov 21, 2024 as substantially equivalent to K896048 (Joint Medical Products Corp., 1990) and 1 other predicate after a 59-day review. Its family tree reaches back 1 generation to 1990. It has been recalled 11 times.
- Decided
- Nov 21, 2024
- Review
- 59 days
- Class
- Class II
- Product code
- KRO
- Recalls
- 11
- Predicates
- 2
Its longest line of descent runs back 1 generation to K896048 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK896048 S-Rom/Noiles Mark 3Joint Medical Products Corp. · 1990 · Recalled
- This deviceK242871 ATTUNE™ Revision Hinge KneeDepuy Ireland UC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896048 | S-Rom/Noiles Mark 3 | Joint Medical Products Corp. | 1990 | 6 |
| 0 (this device) | K242871 | ATTUNE™ Revision Hinge Knee | Depuy Ireland UC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 KRO? 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 KRO device
- #1 K251665 Triathlon® Hinge Knee Systemscore 19.0 · 12 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 |
|---|---|---|---|
| * | K896048 | S-Rom/Noiles Mark 3Summary page 5…orotibial, Constrained, Cemented, Metal/Polymer Legally marketed device(s) to Primary Predicate Device: which equivalence is claimed K896048 – S-ROM/Noiles Mark 3 Secondary Predicate Device: K091453 – DePuy… | 1990 |
| * | K091453 | LPS Universal Tibial Hinge Inserts, Model 198727012-198727331Summary page 5…edicate Device: which equivalence is claimed K896048 – S-ROM/Noiles Mark 3 Secondary Predicate Device: K091453 – DePuy LPS Universal Hinge Insert Assembly Reference Predicate Device:… | 2009 |
| † | K160700 | ATTUNE Revision Knee System | 2016 |
| † | K983014 | Summit Acetabular System | 1998 |
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 |
|---|---|---|---|---|
| May 19, 2026 | Class II | Z-2617-2026 | Under Investigation by firm | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| May 19, 2026 | Class II | Z-2616-2026 | Under Investigation by firm | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| Apr 3, 2026 | Class II | Z-1988-2026 | Under Investigation by firm | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| Apr 3, 2026 | Class II | Z-1991-2026 | Under Investigation by firm | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| Apr 3, 2026 | Class II | Z-1985-2026 | Under Investigation by firm | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| Apr 3, 2026 | Class II | Z-1990-2026 | Under Investigation by firm | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| Apr 3, 2026 | Class II | Z-1986-2026 | Under Investigation by firm | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| Apr 3, 2026 | Class II | Z-1989-2026 | Under Investigation by firm | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| Apr 3, 2026 | Class II | Z-1987-2026 | Under Investigation by firm | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| Apr 3, 2026 | Class II | Z-1992-2026 | Under Investigation by firm | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| Apr 3, 2026 | Class II | Z-1993-2026 | Under Investigation by firm | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- 4 other devices also cite its predicate K896048.
How does its category compare?
All KRO devicesKRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · KRO
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRO
56in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRO
14so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRO
915in 2025
MAUDE reports naming product code KRO, 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 | 1 | — | 1 | 37 |
| 2008 | 3 | 126 | 3 | 44 |
| 2009 | 3 | 86 | 8 | 66 |
| 2010 | 1 | — | 0 | 110 |
| 2011 | 2 | — | 1 | 119 |
| 2012 | 2 | — | 1 | 173 |
| 2013 | 3 | 189 | 2 | 194 |
| 2014 | 2 | — | 0 | 406 |
| 2015 | 6 | 113 | 1 | 333 |
| 2016 | 3 | 148 | 5 | 369 |
| 2017 | 1 | — | 4 | 543 |
| 2018 | 0 | — | 1 | 614 |
| 2019 | 3 | 244 | 0 | 759 |
| 2020 | 1 | — | 0 | 749 |
| 2021 | 3 | 57 | 1 | 770 |
| 2022 | 1 | — | 0 | 892 |
| 2023 | 4 | 148 | 0 | 746 |
| 2024 | 3 | 87 | 0 | 855 |
| 2025 | 3 | 56 | 1 | 915 |
| 2026 | 1 | — | 14 | — |
What is it indicated for?
The ATTUNE Revision Hinge Knee is indicated in cases for cement use in patients who have reached skeletal maturity and for whom the surgeon has decided to resect both cruciate ligaments due to the following conditions:
1. Severe instability, gross deformity and/or bone loss
2. Failure of a previous knee reconstruction procedure.
3. Trauma or tumor resection
4. Absent or markedly insufficient collateral ligaments
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242871 · printed Nov 4, 2026
Cite this page
510(k) Report. “K242871: ATTUNE™ Revision Hinge Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K242871
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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