510(k) · Cleared
ClearedATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System
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 Mar 21, 2024 as substantially equivalent to K111433 (DePuy Orthopaedics, Inc., 2011) and 8 other predicates after a 94-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Mar 21, 2024
- Review
- 94 days
- Class
- Class II
- Product code
- KRO
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 6 generations to K943462 (1994). 38 ancestors in all, the oldest K870730 (1987). 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 backK140881 Depuy Attune Knee System - Cementless CR and PS Femoral ComponenetsDepuy (Ireland) · 2015 · Recalled
- This deviceK233980 ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb…Depuy Ireland UC · 2024
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 | K140881 | Depuy Attune Knee System - Cementless CR and PS Femoral Componenets | Depuy (Ireland) | 2015 | 10 |
| 0 (this device) | 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 |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2017 | 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? (9)
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 |
|---|---|---|---|
| * | K111433 | Depuy Sttune (TM) PS Knee SystemSummary page 5…ofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Legally marketed device(s) to Primary Predicate: K111433 - DePuy Attune TM Knee System which equivalence is claimed Secondary Predicate: K170806 – ATTUNE Cemented Tibial Base, Fixed… | 2011 |
| * | K170806 | ATTUNE Cemented Tibial Base, Fixed BearingSummary page 5…ve/Metal/Polymer + Additive Legally marketed device(s) to Primary Predicate: K111433 - DePuy Attune TM Knee System which equivalence is claimed Secondary Predicate: K170806 – ATTUNE Cemented Tibial Base, Fixed Bearing Reference Devices:… | 2017 |
| * | K140881 | Depuy Attune Knee System - Cementless CR and PS Femoral ComponenetsSummary page 8…osthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Legally marketed device(s) to Primary Predicate: K140881 - ATTUNE TM Knee System- Cementless CR which equivalence is claimed and PS Femoral Components… | 2015 |
| * | K091453 | LPS Universal Tibial Hinge Inserts, Model 198727012-198727331Summary page 11…KRO: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Legally marketed device(s) to Primary Predicate: K091453 – DePuy LPS Universal Hinge Insert Assembly which equivalence is claimed Secondary Predicates: K033959 – LPS ; K003182 – Ortho… | 2009 |
| * | K033959 | LPSSummary page 11…etal/Polymer Legally marketed device(s) to Primary Predicate: K091453 – DePuy LPS Universal Hinge Insert Assembly which equivalence is claimed Secondary Predicates: K033959 – LPS ; K003182 – Orthogenesis LPS System Reference Devices:… | 2004 |
| * | K003182 | Orthogenesis LPS SystemSummary page 11…ally marketed device(s) to Primary Predicate: K091453 – DePuy LPS Universal Hinge Insert Assembly which equivalence is claimed Secondary Predicates: K033959 – LPS ; K003182 – Orthogenesis LPS System Reference Devices:… | 2001 |
| * | K070267 | Depuy GCK Tibial ComponentsSummary page 14…KRR: Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Legally marketed device(s) to Primary Predicate: K070267 - Sigma High Performing Unity Knee which equivalence is claimed Resurfacing Secondary Predicat… | 2007 |
| * | K070849 | Depuy GCK Femoral and Tibial ComponentsSummary page 14…e(s) to Primary Predicate: K070267 - Sigma High Performing Unity Knee which equivalence is claimed Resurfacing Secondary Predicates: K070849 - DePuy GCK Femoral and Tibial Components;… | 2007 |
| * | K061648 | Depuy Graduated Compartmental Knee (GCK)Summary page 15…Preservation System SigmaTM High Performance (HP) Partial Knee System K061648 - DePuy Graduated Compartmental Knee (GCK) Reference Devices: K2323… | 2006 |
| † | K232303 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized… | 2023 |
| † | K212746 | ATTUNE Revision Cones | 2022 |
| † | K230295 | ATTUNE® Revision Cones | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 6.8 years on median.
- 16 of the 38 ancestors have a recall of any class.
- 7 other devices also cite its predicate K111433.
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?
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. The ATTUNE™ Cementless CR and PS Femoral Components are intended for cementless use within the ATTUNE™ Total Knee Replacement System. Candidates for total knee replacement include patients with a severely painful and/or severely disabled…
Read the full statement (277 words)
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.
The ATTUNE™ Cementless CR and PS Femoral Components are intended for cementless use within the ATTUNE™ Total Knee Replacement System.
Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present).
The DePuy LPS System is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and 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 noninflammatory 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.
The LPS System is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.
The S-ROM tibial tray and the non-porous coated straight and bowed stems are intended for cemented use only.
The porous-coated metaphyseal sleeves are intended for either cemented or cementless applications.
The SIGMA™ High Performance Partial Knee System is indicated for single compartmental knee replacement in skeletally mature individuals with osteoarthritis, post-traumatic arthritis of the tibiofemoral surfaces or a history of gout or pseudogout. All components are intended for CEMENTED USE ONLY.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233980 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233980: ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233980
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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