510(k) · Cleared
ClearedRT-Plus PE Insert Clamp
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 Jun 21, 2002 as substantially equivalent to K003504 (Plus Orthopedics, 2001) after a 28-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Jun 21, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- KRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003504 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK003504 RT-Plus Modular Cemented Knee ComponentsPlus Orthopedics · 2001
- This deviceK021714 RT-Plus PE Insert ClampPlus Orthopedics · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003504 | RT-Plus Modular Cemented Knee Components | Plus Orthopedics | 2001 | — |
| 0 (this device) | K021714 | RT-Plus PE Insert Clamp | Plus Orthopedics | 2002 | — |
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? (1)
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 |
|---|---|---|---|
| * | K003504 | RT-Plus Modular Cemented Knee ComponentsSummary page 1…e System, KO03504 - S/E 5/11/01 Device The snapping mechanism of the PE tibial inserts for the RT-PLUSTM Modification Knee System (S/E May 11,2001 - K003504) has been modified by Description: adding a clamp to secure the PE insert to the tibial component. All PE… | 2001 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K003504.
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 tri-compartmental rotating hinged prosthesis of the total condylar type. The system consists of femoral, tibial and patellar components. It is indicated for use as a replacement of the knee joint in which significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, revision or connective tissue disorders. The RT-PLUS™ Modular Cemented Knee provides joint stability when any or all of the following structures are non-functional: MCL, LCL, PCL, ACL and the iliotibial band.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021714 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021714: RT-Plus PE Insert Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021714
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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