# K133152: JTS Extendible Distal Femoral Implant

- Pathway: 510(k) (Special)
- Applicant: Stanmore Implants Worldwide, Ltd.
- Decided: Jan 22, 2014 after 61 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K945028 (1996). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092138: JTS Extendeable Implant, Stanmore Implants Worldwide, Ltd. (2011) Summary page 1.
- K120992: Mets Smiles Total Knee Replacement, Stanmore Implants Worldwide, Ltd. (2012) Summary page 1.
- K121055: Mets Modular Total Femur, Stanmore Implants Worldwide, Ltd. (2012) Summary page 2.
- K121029: Mets Modular Distal Femur, Stanmore Implants Worldwide, Ltd. (2012) Summary page 2.

## Most influential descendants
- K140900: Patient Specific Smiles Total Knee Replacement (2015), 0 descendants of its own
- K140898: Patient Specific Distal Femoral (2015), 0 descendants of its own

## Recalls of this device
- Jul 4, 2017 · Class II · Z-3104-2017: Three (3) complaints were identified in which the potential for utilization of the JTS Grower Drive in the incorrect orientation in relation to the limb entry point of the device, together with the po

## Indications for use
The JTS Extendible Distal Femoral Implant is indicated for cemented limb salvage procedures in paediatric (between the ages of 2 and 21) cases where radical resection and replacement of the distal femur is required with the following conditions: * patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment; * surgical intervention for severe trauma, revision knee arthroplasties, failed previous prosthesis and/or oncology indications; and * malignant diseases (e.g., osteogenic sarcoma). The JTS Extendible Distal Femoral Implant and its components are for single use only

Source page: https://510kreport.com/device/K133152
Methodology: https://510kreport.com/methodology