# K240834: EcoFit® short stem cementless cpTi

- Pathway: 510(k) (Traditional)
- Applicant: Implantcast GmbH
- Decided: Jun 3, 2024 after 69 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: 14 generations back to K931641 (1994). 312 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 313 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 5.
- K203420: EcoFit® Hip System, Implantcast GmbH (2021) Summary page 5.
- K191569: Implantcast ic-Bipolar Head System, Implantcast GmbH (2019) Summary page 5.
- K180263: EcoFit Vit E Acetabular System, Implantcast GmbH (2018) Summary page 5.

## Most influential descendants
- K260037: implantcast Packaging System Update (2026), 0 descendants of its own

## Indications for use
The EcoFit® hip stems are intended to be used in total hip arthroplasty for the following indications: - 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® hip stems are intended for uncemented, press-fit fixation. The EcoFit® hip stems are intended to be used in partial (hemi) hip arthroplasty in conjunction with the ic-Bipolar Head 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/K240834
Methodology: https://510kreport.com/methodology