510(k) · Cleared
ClearedDepuy LPS Proximal Tibial Component
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 Oct 13, 2006 as substantially equivalent to K011810 (Depuy, Inc., 2001) and 1 other predicate after a 66-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Oct 13, 2006
- Review
- 66 days
- Class
- Class II
- Product code
- KRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K870730 (1987). 12 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K870730 | Noiles Total Knee Prosthesis | Joint Medical Products Corp. | 1987 | — |
| −2 | K003182 | Orthogenesis LPS System | Depuy, Inc. | 2001 | — |
| −1 | K033959 | LPS | Depuy, Inc. | 2004 | — |
| 0 (this device) | K062301 | Depuy LPS Proximal Tibial Component | DePuy Orthopaedics, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K011810 | Orthogenesis LPS Proximal Tibial Replacement and Orthogenesis LPS Tibial Bearing | 2001 |
| * | K033959 | LPSSummary page 1…VICES: DePuy Orthogenesis LPS Proximal Tibial Replacement System (KOI 1810) DePuy LPS (K033959) DEVICE DESCRIPTION: The DePuy LPS Proximal Tibial Component is a modular component that is designed to replace the proximal p… | 2004 |
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 19 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 12 ancestors have a recall of any class.
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.
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; patient conditions of noninflammatory degenerative joint…
Read the full statement (144 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;
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 is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.
The distal femoral component, the S-ROM Tibial Tray and the non-porous coated straight and bowed stems are intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062301 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062301: Depuy LPS Proximal Tibial Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062301
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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