# K121055: Mets Modular Total Femur

- Pathway: 510(k) (Traditional)
- Applicant: Stanmore Implants Worldwide, Ltd.
- Decided: Sep 19, 2012 after 166 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K021489 (2002). 5 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 9 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.
- K002757: Oncology Salvage System, Biomet, Inc. (2000) Summary page 1.
- K023087: Global Modular Replacement System (GMRS), Howmedica Osteonics Corp. (2002) Summary page 1.
- K963313: Exactech All Poly Acetabular Cup, Exactech, Inc. (1996) 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

## Indications for use
The METS® Modular Total Femur is intended for the replacement of the total femoral bone. 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 resections Revision of previously failed total joint arthroplasty Trauma Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement; unmanageable using other techniques All of the METS® Modular Total Femur tibial and acetabular components are for cemented use only All of the METS® Modular Total Femur and their components are for single use only

Source page: https://510kreport.com/device/K121055
Methodology: https://510kreport.com/methodology