# K140900: Patient Specific Smiles Total Knee Replacement

- Pathway: 510(k) (Special)
- Applicant: Stanmore Worldwide Implants, Ltd.
- Decided: Feb 12, 2015 after 310 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: 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)
- K120992: Mets Smiles Total Knee Replacement, Stanmore Implants Worldwide, Ltd. (2012) Summary page 6.
- K092138: JTS Extendeable Implant, Stanmore Implants Worldwide, Ltd. (2011) Summary page 6.
- K133152: JTS Extendible Distal Femoral Implant, Stanmore Implants Worldwide, Ltd. (2014) Summary page 6.

## Indications for use
The Patient Specific SMILES Total Knee Replacement is intended for the replacement of diseased or deficient bone around the knee joint. It is indicated for: 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 fixed hinge tibial component is intended for limb salvage procedures requiring radical resection of bone and soft tissue The Patient Specific SMILES Total Knee Replacement and its components are for cemented use only. The Patient Specific Patient Specific SMILES Total Knee Replacement and its components are for single use only.

Source page: https://510kreport.com/device/K140900
Methodology: https://510kreport.com/methodology