# K021489: Repiphysis Limb Salvage System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Dec 4, 2002 after 210 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
No predicates in its family tree.
9 later devices descend from it; 5 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K092138: JTS Extendeable Implant (2011), 7 descendants of its own
- K121029: Mets Modular Distal Femur (2012), 3 descendants of its own
- K121055: Mets Modular Total Femur (2012), 3 descendants of its own
- K120992: Mets Smiles Total Knee Replacement (2012), 3 descendants of its own
- K133152: JTS Extendible Distal Femoral Implant (2014), 2 descendants of its own

## Indications for use
Limb salvage surgery is indicated for cemented procedures where radical resection and replacement of the distal femur and/or proximal tibia is required with the following conditions: 1. patients suffering from severe arthropathy of the knee that does not respond to any cqnservative therapy or better alternative surgical treatment; 2. surgical intervention for severe trauma. revision knee arthroplasties, and/or oncology indications. 3. metastatic diseases (e.g., osteosarcomas, chondrosarcomas, gaint cell tumors, bone tumors)

Source page: https://510kreport.com/device/K021489
Methodology: https://510kreport.com/methodology