510(k) · Cleared
ClearedRT-Plus Modular Cemented Knee Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plus Orthopedics · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on May 11, 2001 after a 179-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 27 later devices descend from it.
- Decided
- May 11, 2001
- Review
- 179 days
- Class
- Class II
- Product code
- KRO
- Recalls
- None
- Predicates
- 0
27 later devices descend from it, 4 citing it directly.
- This deviceK003504 RT-Plus Modular Cemented Knee ComponentsPlus Orthopedics · 2001
- Descendant · cites it directly · 20 of its ownK013340 RT-Plus Knee Additional ComponentsPlus Orthopedics · 2001
- Descendant · cites it directly · 19 of its ownK023667 RT-Plus Solution & RT-Plus Modular Solution KneePlus Orthopedics · 2002
- Descendant · 2 generations on · 11 of its ownK081111 Legion Hinge Knee SystemSmith & Nephew, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 6 of its ownK032215 VKS/TC-Plus Revision KneePlus Orthopedics · 2003
- Descendant · 3 generations on · 5 of its ownK121393 Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc. · 2012 · Recalled
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K013340RT-Plus Knee Additional ComponentsPlus Orthopedics · 2001 · cites it directly20descendants
- K023667RT-Plus Solution & RT-Plus Modular Solution KneePlus Orthopedics · 2002 · cites it directly19descendants
- K081111Legion Hinge Knee SystemSmith & Nephew, Inc. · 2008 · 2 generations on11descendants
- K032215VKS/TC-Plus Revision KneePlus Orthopedics · 2003 · 2 generations on6descendants
- K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc. · 2012 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003504 | RT-Plus Modular Cemented Knee Components | Plus Orthopedics | 2001 | — |
| +1 | K013340 | RT-Plus Knee Additional Components | Plus Orthopedics | 2001 | — |
| +1 | K023667 | RT-Plus Solution & RT-Plus Modular Solution Knee | Plus Orthopedics | 2002 | — |
| +2 | K081111 | Legion Hinge Knee System | Smith & Nephew, Inc. | 2008 | 7 |
| +2 | K032215 | VKS/TC-Plus Revision Knee | Plus Orthopedics | 2003 | — |
| +3 | K121393 | Smith & Nephew, Inc. Total Knee System Instrumentation | Smith & Nephew, Inc. | 2012 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (27)
See all 274 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, K013340 (Plus Orthopedics, 2001) has gone furthest, with 20 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.
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 | — |
https://510kreport.com/device/K003504 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003504: RT-Plus Modular Cemented Knee Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003504
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026