# K092138: JTS Extendeable Implant

- Pathway: 510(k) (Traditional)
- Applicant: Stanmore Implants Worldwide, Ltd.
- Decided: Mar 22, 2011 after 615 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: 1 generation back to K021489 (2002). 2 ancestors in all.
7 later devices descend from it; 7 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)
- K021489: Repiphysis Limb Salvage System, Wrightmedicaltechnologyinc (2002) Summary page 1.
- K023087: Global Modular Replacement System (GMRS), Howmedica Osteonics Corp. (2002) Summary page 1.

## Most influential descendants
- 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
- K140900: Patient Specific Smiles Total Knee Replacement (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 Implant is indicated for cemented limb sparing procedures in paedliatric (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 prostheses and/or oncology indications; and malignant diseases (e.g osteogenic sarcoma). The JTS® Extendible Implant and its components are for single use only

Source page: https://510kreport.com/device/K092138
Methodology: https://510kreport.com/methodology