# K163577: Ecofit® Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Implantcast GmbH
- Decided: Sep 25, 2017 after 279 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K931641 (1994). 286 ancestors in all.
9 later devices descend from it; 7 cite it directly.
0 of 295 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101086: Taperloc Complete, Biomet, Inc. (2010) Summary page 4.
- K103755: Taperloc Complete, Size 5 and 6, Biomet Manufacturing Corp (2011) Summary page 4.
- K032726: Zimmer M/L Taper Hip Prosthesis, 7711 Series, Zimmer, Inc. (2003) Summary page 4.
- K120030: Taperloc Complete Size 4MM and XR 123, Biomet Manufacturing Corp (2012) Summary page 4.
- K110400: Taperloc Complete Microplasty Stem, Biomet Manufacturing Corp (2011) 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.
- K161184: iNSitu Total Hip System, Theken Companies, LLC (2016) Summary page 4.
- K932755: Reflection Acetabular Component, Smith & Nephew Richards, Inc. (1994) Summary page 4.
- K022556: Reflection Modified Acetabular Shells, Smith & Nephew, Inc. (2002) Summary page 4.
- K071535: Biolox Delta Ceramic Femoral Head, Zimmer, Inc. (2007) Summary page 4.
- K130899: Biolox Delta Ceramic Femoral Heads, Zimmer GmbH (2013) Summary page 4.
- K061786: Versys Fiber Metal Midcoat Low Head Center Hip Prosthesis, Zimmer, Inc. (2006) Summary page 4.
- K964769: Versys Hip System--Fiber Metal Taper Hip Prosthesis, Zimmer, Inc. (1997) Summary page 4.
- K143407: Klassic HD Hip System, Total Joint Othopedics, Inc. (2014) Summary page 4.

## Most influential descendants
- K180263: EcoFit Vit E Acetabular System (2018), 5 descendants of its own
- K203420: EcoFit® Hip System (2021), 4 descendants of its own
- K210678: implaFit® hip stems (2022), 3 descendants of its own
- K240834: EcoFit® short stem cementless cpTi (2024), 1 descendant of its own
- K232371: Actinia® hip stems (2023), 1 descendant of its own

## Recalls of this device
- May 10, 2021 · Class II · Z-2050-2021: A risk exists during impacting of the acetabular cup into the bone the plugs may come loose from the cup, which could lead to operation duration extension or revision operation. A warning note is bein

## 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 are intended for uncemented, press-fit fixation.

Source page: https://510kreport.com/device/K163577
Methodology: https://510kreport.com/methodology