# K252451: EPORE® XO cup system

- Pathway: 510(k) (Traditional)
- Applicant: Implantcast GmbH
- Decided: Apr 24, 2026 after 263 days
- Product code: OQI (Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, 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). 305 ancestors in all.
No later device cites it as a predicate yet.
0 of 305 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180263: EcoFit Vit E Acetabular System, Implantcast GmbH (2018) Summary page 5.
- K203420: EcoFit® Hip System, Implantcast GmbH (2021) Summary page 5.
- K163577: Ecofit® Hip System, Implantcast GmbH (2017) Summary page 5.

## Indications for use
The EPORE® XO cup system is intended for hip joint arthroplasty 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 hip arthroplasty. The EPORE® XO acetabular cups are intended for uncemented biological fixation. The EPORE® XO cup system acetabular cups and cup inserts are intended to be used with mating femoral heads.

Source page: https://510kreport.com/device/K252451
Methodology: https://510kreport.com/methodology