510(k) · Cleared
Recalled · Class II · 2023Attune Revision LPS Inserts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy (Ireland) · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Oct 8, 2019 as substantially equivalent to K091453 (DePuy Orthopaedics, Inc., 2009) and 3 other predicates after a 98-day review. Its family tree reaches back 6 generations to 1994. It has been recalled 4 times.
- Decided
- Oct 8, 2019
- Review
- 98 days
- Class
- Class II
- Product code
- KRO
- Recalls
- 4
- Predicates
- 4
Its longest line of descent runs back 6 generations to K943462 (1994). 17 ancestors in all, the oldest K922620 (1992). No later device cites it as a predicate yet.
- Root · 6 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 5 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
- 4 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
- 3 generations backK101433 Depuy Attune Knee SystemDePuy Orthopaedics, Inc. · 2010
- 2 generations backK111433 Depuy Sttune (TM) PS Knee SystemDePuy Orthopaedics, Inc. · 2011 · Recalled
- 1 generation backK160700 ATTUNE Revision Knee SystemDepuy (Ireland) · 2016 · Recalled
- This deviceK191779 Attune Revision LPS InsertsDepuy (Ireland) · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K943462 | Darwin Knee System | Johnson & Johnson Professionals, Inc. | 1994 | 8 |
| −5 | K033272 | Depuy Sigma Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | 51 |
| −4 | K040166 | Depuy Sigma XLK Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | — |
| −3 | K101433 | Depuy Attune Knee System | DePuy Orthopaedics, Inc. | 2010 | — |
| −2 | K111433 | Depuy Sttune (TM) PS Knee System | DePuy Orthopaedics, Inc. | 2011 | 1 |
| −1 | K160700 | ATTUNE Revision Knee System | Depuy (Ireland) | 2016 | 5 |
| 0 (this device) | K191779 | Attune Revision LPS Inserts | Depuy (Ireland) | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K091453 | LPS Universal Tibial Hinge Inserts, Model 198727012-198727331Summary page 4…edics Regulation 21 CFR 888.3510 Product Code(s) KRO Legally marketed device(s) Primary: LPS Universal Hinge Tibial Inserts, K091453 to which equivalence is Secondary: ATTUNE Knee System AOX Tibial Inserts, K101433, claimed K111… | 2009 |
| * | K101433 | Depuy Attune Knee SystemSummary page 4…Legally marketed device(s) Primary: LPS Universal Hinge Tibial Inserts, K091453 to which equivalence is Secondary: ATTUNE Knee System AOX Tibial Inserts, K101433, claimed K111433, K160700 Device description The ATTUNE Revision LPS Inserts are designed… | 2010 |
| * | K111433 | Depuy Sttune (TM) PS Knee SystemSummary page 4…LPS Universal Hinge Tibial Inserts, K091453 to which equivalence is Secondary: ATTUNE Knee System AOX Tibial Inserts, K101433, claimed K111433, K160700 Device description The ATTUNE Revision LPS Inserts are designed to replace the tibio-… | 2011 |
| * | K160700 | ATTUNE Revision Knee SystemSummary page 4…ersal Hinge Tibial Inserts, K091453 to which equivalence is Secondary: ATTUNE Knee System AOX Tibial Inserts, K101433, claimed K111433, K160700 Device description The ATTUNE Revision LPS Inserts are designed to replace the tibio-… | 2016 |
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 |
|---|---|---|---|---|
| Feb 15, 2023 | Class II | Z-1265-2023 | Labeling Change Control | The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant… |
| Feb 15, 2023 | Class II | Z-1263-2023 | Labeling Change Control | The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant… |
| Feb 15, 2023 | Class II | Z-1264-2023 | Labeling Change Control | The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant… |
| Feb 15, 2023 | Class II | Z-1266-2023 | Labeling Change Control | The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 10 of the 17 ancestors have a recall of any class.
- 2 other devices also cite its predicate K091453.
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. 2019, 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 LPS Insert is intended for use in prosthetic constructs for replacement of distal and/or total femur and resurfacing of the proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include: • malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement; • patient conditions of non-inflammatory…
Read the full statement (120 words)
The ATTUNE Revision LPS Insert is intended for use in prosthetic constructs for replacement of distal and/or total femur and resurfacing of the proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:
• malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement;
• patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement;
• revision cases for a failed previous prosthesis requiring extensive resection and replacement;
• severe trauma requiring extensive resection and replacement.
• post-infection bone loss, where the surgeon has elected to excise the bone and replacement is required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191779 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191779: Attune Revision LPS Inserts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191779
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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