# K180263: EcoFit Vit E Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Implantcast GmbH
- Decided: Jul 20, 2018 after 171 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: 12 generations back to K931641 (1994). 301 ancestors in all.
5 later devices descend from it; 5 cite it directly.
0 of 306 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 4.
- K091508: Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System, Zimmer, Inc. (2009) Summary page 4.
- K042344: Excia Total Hip System, Aesculap, Inc. (2005) Summary page 4.
- K061699: EXCIA, Aesculap, Inc. (2006) Summary page 4.
- K141972: Klassic HD Acetabular Insert with E-Link Poly, Total Joint Orthopedics, Inc. (2014) Summary page 4.
- K171181: PROCOTYL® PRIME E-CLASS™ XLPE Liner, Microport Orthopedics, Inc. (2017) Summary page 4.
- K142119: Procotyl L-O Acetabular System, Microport Orthopedics, Inc. (2015) Summary page 4.
- K123392: Avenir Muller Stem, Zimmer GmbH (2013) Summary page 4.

## Most influential descendants
- K203420: EcoFit® Hip System (2021), 4 descendants of its own
- 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
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® Hip Stem and EcoFit® Acetabular Cup is intended for uncemented, press-fit fixation.

Source page: https://510kreport.com/device/K180263
Methodology: https://510kreport.com/methodology