# K203420: EcoFit® Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Implantcast GmbH
- Decided: Feb 3, 2021 after 76 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K931641 (1994). 304 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 308 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163577: Ecofit® Hip System, Implantcast GmbH (2017) Summary page 7.
- K180263: EcoFit Vit E Acetabular System, Implantcast GmbH (2018) Summary page 7.
- K101229: Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular System and Trilogy Integrated Taper, Zimmer, Inc. (2010) Summary page 7.

## Most influential descendants
- K240834: EcoFit® short stem cementless cpTi (2024), 1 descendant of its own
- K223103: BethaLoc® stem cementless HA (2023), 1 descendant of its own
- K252451: EPORE® XO cup system (2026), 0 descendants of its own
- K260037: implantcast Packaging System Update (2026), 0 descendants of its own

## Indications for use
Acetabular Inserts The EcoFit® Hip System is indicated for use as a total hip replacement in cases of: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; - Rheumatoid arthritis; - Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and - Revision of previously failed total hip arthroplasty. The EcoFit® Acetabular Cup is intended for uncemented, press-fit fixation. The MUTARS® Proximal Femur Replacement System is a modular hip replacement system offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient. The MUTARS® Proximal Femur System is intended for uncemented use in total hip arthroplasty or hemiarthroplasty for the following indications: - Proximal femur replacement in oncology cases where radical resection and replacement of bone is required. - Limb salvage procedures including surgical intervention for severe trauma, failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required. Femoral Stems The EcoFit® Hip System is indicated for use as a total hip replacement in cases of: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; - Rheumatoid arthritis; - Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and - Revision of previously failed total hip arthroplasty. The EcoFit® Acetabular Cup is intended for uncemented, press-fit fixation. The MUTARS® ic-Bipolar Head System is intended for uncemented use in hemiarthroplasty, where the femoral head requires replacement but the acetabulum does not, in conjunction with the EcoFit® Hip System and MUTARS® Proximal Femur Replacement System for the following indications: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis - Correction of functional deformity - Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

Source page: https://510kreport.com/device/K203420
Methodology: https://510kreport.com/methodology