# K121056: Mets Modular Proximal Femur

- Pathway: 510(k) (Traditional)
- Applicant: Stanmore Implants Worldwide, Ltd.
- Decided: Sep 20, 2012 after 167 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.
No later device cites it as a predicate yet.
0 of 6 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.

## Indications for use
Intended for the replacement of diseased or deficient bone in the proximal 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 resections Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques Revision of previously failed total joint arthroplasty Trauma The METS® Modular Proximal Femur and its components are for single use Only The METS® Modular Proximal Femur and its components are for cemented use only

Source page: https://510kreport.com/device/K121056
Methodology: https://510kreport.com/methodology