510(k) · Cleared
ClearedRT-Plus Solution & RT-Plus Modular Solution Knee
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 Dec 24, 2002 as substantially equivalent to K013340 (Plus Orthopedics, 2001) and 1 other predicate after a 54-day review. Its family tree reaches back 2 generations to 2001. 19 later devices descend from it.
- Decided
- Dec 24, 2002
- Review
- 54 days
- Class
- Class II
- Product code
- KRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K003504 (2001). 19 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK003504 RT-Plus Modular Cemented Knee ComponentsPlus Orthopedics · 2001
- 1 generation backK013340 RT-Plus Knee Additional ComponentsPlus Orthopedics · 2001
- This deviceK023667 RT-Plus Solution & RT-Plus Modular Solution KneePlus Orthopedics · 2002
- Descendant · cites it directly · 11 of its ownK081111 Legion Hinge Knee SystemSmith & Nephew, Inc. · 2008 · Recalled
- Descendant · cites it directly · 6 of its ownK032215 VKS/TC-Plus Revision KneePlus Orthopedics · 2003
- Descendant · 2 generations on · 5 of its ownK121393 Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc. · 2012 · Recalled
- Descendant · cites it directly · 5 of its ownK053390 Columbus (CR) Total Knee SystemAesculap, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 4 of its ownK151118 Smith and Nephew Legion Hinge Knee SystemSmith & Nephew · 2015
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K081111Legion Hinge Knee SystemSmith & Nephew, Inc. · 2008 · cites it directly11descendants
- K032215VKS/TC-Plus Revision KneePlus Orthopedics · 2003 · cites it directly6descendants
- K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc. · 2012 · 2 generations on5descendants
- K053390Columbus (CR) Total Knee SystemAesculap, Inc. · 2006 · cites it directly5descendants
- K151118Smith and Nephew Legion Hinge Knee SystemSmith & Nephew · 2015 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003504 | RT-Plus Modular Cemented Knee Components | Plus Orthopedics | 2001 | — |
| −1 | K013340 | RT-Plus Knee Additional Components | Plus Orthopedics | 2001 | — |
| 0 (this device) | K023667 | RT-Plus Solution & RT-Plus Modular Solution Knee | Plus Orthopedics | 2002 | — |
| +1 | K081111 | Legion Hinge Knee System | Smith & Nephew, Inc. | 2008 | 7 |
| +1 | K032215 | VKS/TC-Plus Revision Knee | Plus Orthopedics | 2003 | — |
| +2 | K121393 | Smith & Nephew, Inc. Total Knee System Instrumentation | Smith & Nephew, Inc. | 2012 | 4 |
| +1 | K053390 | Columbus (CR) Total Knee System | Aesculap, Inc. | 2006 | 1 |
| +2 | K151118 | Smith and Nephew Legion Hinge Knee System | Smith & Nephew | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K013340 | RT-Plus Knee Additional ComponentsSummary page 1…morotibial, Constrained, Cemented, MetaVPolymer (per 21 CFR section 888.3510) Equivalent Device The RT-PLUS and RT-PLUS Knee systems are equivalent to the RT-PLUS Knee (K013340) and RT- PLUS Modular Knee (K003504). Device Description The RT-PLUS Knee and RT-PLUS Modular Knee are hinged tri-compartmental… | 2001 |
| * | K003504 | RT-Plus Modular Cemented Knee ComponentsSummary page 1…etaVPolymer (per 21 CFR section 888.3510) Equivalent Device The RT-PLUS and RT-PLUS Knee systems are equivalent to the RT-PLUS Knee (K013340) and RT- PLUS Modular Knee (K003504). Device Description The RT-PLUS Knee and RT-PLUS Modular Knee are hinged tri-compartmental prostheses with femoral, tibial, and… | 2001 |
What descends from it? (19)
See all 193 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?
- The line of descent spans 1 year and passes through 1 company; a new generation was cleared every 1.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K081111 (Smith & Nephew, Inc., 2008) has gone furthest, with 11 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 | — |
What is it indicated for?
The RT-PLUS Knee System is a trkompartmental rotating hinged prosthesis of the total condylar type. The system consists of femoral, tibial and patellar components. It is indicated for use for replacement of the total knee joint in which significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infections, revision or connective tissue disorders. RT-PLUS Modular Knee provides joint stability when any or all of the following structures are non-functional: MCL, LCL, PCL, ACL or the illiotibial band.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023667 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023667: RT-Plus Solution & RT-Plus Modular Solution Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023667
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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