510(k) · Cleared
ClearedLPS Universal Tibial Hinge Inserts, Model 198727012-198727331
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Aug 12, 2009 after an 86-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Aug 12, 2009
- Review
- 86 days
- Class
- Class II
- Product code
- KRO
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK091453 LPS Universal Tibial Hinge Inserts, Model 198727012-198727331DePuy Orthopaedics, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK242871 ATTUNE™ Revision Hinge KneeDepuy Ireland UC · 2024 · Recalled
- Descendant · cites it directly · 0 of its ownK233980 ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb…Depuy Ireland UC · 2024
- Descendant · cites it directly · 0 of its ownK191779 Attune Revision LPS InsertsDepuy (Ireland) · 2019 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K242871ATTUNE™ Revision Hinge KneeDepuy Ireland UC · 2024 · cites it directly0descendants
- K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System…Depuy Ireland UC · 2024 · cites it directly0descendants
- K191779Attune Revision LPS InsertsDepuy (Ireland) · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091453 | LPS Universal Tibial Hinge Inserts, Model 198727012-198727331 | DePuy Orthopaedics, Inc. | 2009 | — |
| +1 | K242871 | ATTUNE™ Revision Hinge Knee | Depuy Ireland UC | 2024 | 11 |
| +1 | K233980 | ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation… | Depuy Ireland UC | 2024 | — |
| +1 | K191779 | Attune Revision LPS Inserts | Depuy (Ireland) | 2019 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2024 | 2 | 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?
The FDA summary names no predicate by number.
What descends from it? (3)
3 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K242871 (Depuy Ireland UC, 2024) has gone furthest, with 0 descendants of its own.
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. 2009, 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 DePuy LPS 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; a patient conditions of noninflammatory degenerative…
Read the full statement (155 words)
The DePuy LPS 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;
a 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.
It 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 and diaphyseal sleeves are intended for either cemented or cementless applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091453 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091453: LPS Universal Tibial Hinge Inserts, Model 198727012-198727331.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091453
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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