# K120992: Mets Smiles Total Knee Replacement

- Pathway: 510(k) (Traditional)
- Applicant: Stanmore Implants Worldwide, Ltd.
- Decided: Sep 5, 2012 after 156 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945028 (1996). 7 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 11 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.
- K051570: Avl Hinge Knee System, Biomet, Inc. (2005) Summary page 1.
- K021489: Repiphysis Limb Salvage System, Wrightmedicaltechnologyinc (2002) Summary page 1.

## Most influential descendants
- 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
- K140898: Patient Specific Distal Femoral (2015), 0 descendants of its own

## Recalls of this device
- Dec 7, 2016 · Class II · Z-0823-2017: The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
- Dec 7, 2016 · Class II · Z-0820-2017: The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
- Dec 7, 2016 · Class II · Z-0821-2017: The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
- Dec 7, 2016 · Class II · Z-0822-2017: The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
- Dec 7, 2016 · Class II · Z-0824-2017: The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
- May 31, 2016 · Class II · Z-2553-2016: The manufacturer has identified that the stated Femoral Plateau Plates may not fit into the intended Femoral Knee mating component and thus sit flush upon the Femoral Knee component prior to implantat

## Indications for use
The METS® Smiles Total Knee Replacement is intended for the replacement of diseased or deficient bone around the knee joint. 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis 2. Correction of varus, valgus or post traumatic deformity 3. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement 4. Ligament deficiencies 5. Tumor resections 6. Revision of previously failed total joint arthroplasty 7. Trauma 8. The fixed hinge tibial component is intended for limb salvage procedures requiring radical resection of bone and soft tissue The METS® Smiles Total Knee Replacement is for cemented use only. The METS® Smiles Total Knee Replacement and its components are for single use only

Source page: https://510kreport.com/device/K120992
Methodology: https://510kreport.com/methodology