510(k) · Cleared
ClearedOrthogenesis LPS Proximal Tibial Replacement and Orthogenesis LPS Tibial Bearing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Sep 7, 2001 as substantially equivalent to K896048 (Joint Medical Products Corp., 1990) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.
- Decided
- Sep 7, 2001
- Review
- 88 days
- Class
- Class II
- Product code
- KRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K896048 (1990). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK896048 S-Rom/Noiles Mark 3Joint Medical Products Corp. · 1990 · Recalled
- This deviceK011810 Orthogenesis LPS Proximal Tibial Replacement and Orthogenesis LPS…Depuy, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK062301 Depuy LPS Proximal Tibial ComponentDePuy Orthopaedics, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K062301Depuy LPS Proximal Tibial ComponentDePuy Orthopaedics, Inc. · 2006 · cites it directly0descendants
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) | K011810 | Orthogenesis LPS Proximal Tibial Replacement and Orthogenesis LPS Tibial Bearing | Depuy, Inc. | 2001 | — |
| +1 | K062301 | Depuy LPS Proximal Tibial Component | DePuy Orthopaedics, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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? (3)
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 2…mal Tibial Replacement is substantiated by its similarity in indications for use, design, materials, sterilization and packaging to the S-ROM Noiles Rotating Hinge Knee (K896048 and K905810), and the Orthogenesis LPS system. The determination of substantial equivalence for this device was based on a detai… | 1990 |
| * | K905810 | Noiles (TM) Total Knee Prosthesis, ModificationSummary page 2…eplacement is substantiated by its similarity in indications for use, design, materials, sterilization and packaging to the S-ROM Noiles Rotating Hinge Knee (K896048 and K905810), and the Orthogenesis LPS system. The determination of substantial equivalence for this device was based on a detailed device d… | 1991 |
| * | — | Orthogenesis LPS system Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062301 | Depuy LPS Proximal Tibial Component | 2006 | 0 |
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?
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 Orthogenesis LPS is intended for use in replacement of the mid-shaft or intercalary portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and restoration. Specific diagnostic indications for use include: . metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or…
Read the full statement (156 words)
The Orthogenesis LPS is intended for use in replacement of the mid-shaft or intercalary portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and restoration. Specific diagnostic indications for use include:
. metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur;
. patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IID), e.g., rheumatoid arthritis, requiring extensive resection and replacement of the proximal and/or distal femur;
. patients suffering from severe arthropathy of the hip and/or knee that does not respond to any conservative therapy or better alternative surgical treatment;
o revision cases requiring extensive resection(s) and replacements of the proximal, distal or total femur or proximal tibia.
The distal femoral and tibial components, tibial stems and non-porous coated femoral stems are intended for cemented use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011810: Orthogenesis LPS Proximal Tibial Replacement and Orthogenesis LPS Tibial Bearing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011810
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026