# K140898: Patient Specific Distal Femoral

- Pathway: 510(k) (Special)
- Applicant: Stanmore Implants Worldwide, Ltd.
- Decided: Jan 20, 2015 after 287 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K945028 (1996). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121029: Mets Modular Distal Femur, Stanmore Implants Worldwide, Ltd. (2012) Summary page 5.
- K092138: JTS Extendeable Implant, Stanmore Implants Worldwide, Ltd. (2011) Summary page 5.
- K133152: JTS Extendible Distal Femoral Implant, Stanmore Implants Worldwide, Ltd. (2014) Summary page 5.

## Recalls of this device
- Aug 24, 2022 · Class II · Z-1778-2022: A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ. However, the device in-situ was a MK3 Tibial Metal Casing. The supplied MK4 tibial bearing was not ex
- 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 Patient Specific Distal Femur is intended for the replacement of diseased or deficient bone in the distal femur. It is indicated for: • Limb salvage procedures where radical resection and replacement of the bone is required • Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis • Correction of varus, valgus or post traumatic deformity • Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement • Ligament deficiencies • Tumor resection • Revision of previously failed total joint arthroplasty • Trauma The Patient Specific Distal Femur and its components are for single use only. The Patient Specific Distal Femur and is components are for cemented use only.

Source page: https://510kreport.com/device/K140898
Methodology: https://510kreport.com/methodology