# K013340: RT-Plus Knee Additional Components

- Pathway: 510(k) (Special)
- Applicant: Plus Orthopedics
- Decided: Dec 20, 2001 after 72 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003504 (2001). 1 ancestor in all.
20 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003504: RT-Plus Modular Cemented Knee Components, Plus Orthopedics (2001) Summary page 1.

## Most influential descendants
- K023667: RT-Plus Solution & RT-Plus Modular Solution Knee (2002), 19 descendants of its own
- K081111: Legion Hinge Knee System (2008), 11 descendants of its own
- K032215: VKS/TC-Plus Revision Knee (2003), 6 descendants of its own
- K121393: Smith & Nephew, Inc. Total Knee System Instrumentation (2012), 5 descendants of its own
- K053390: Columbus (CR) Total Knee System (2006), 5 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K013340
Methodology: https://510kreport.com/methodology