# K210678: implaFit® hip stems

- Pathway: 510(k) (Traditional)
- Applicant: Implantcast GmbH
- Decided: Aug 17, 2022 after 530 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: 17 generations back to K941847 (1994). 345 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 348 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.
- K193398: Summit DuoFix HA Coating, DePuy Orthopaedics, Inc. (2020) Summary page 5.
- K013352: Summit Cemented Hip Prosthesis, DePuy Orthopaedics, Inc. (2001) Summary page 5.

## Most influential descendants
- K232371: Actinia® hip stems (2023), 1 descendant of its own
- K260037: implantcast Packaging System Update (2026), 0 descendants of its own
- K252401: implaFit® short stems (2026), 0 descendants of its own

## Indications for use
The implaFit® hip stems are indicated for use 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 implaFit® hip stems, when used in conjunction with the ic-Bipolar Heads, are intended 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. The implaFit® hip stems cementless are intended for uncemented, press-fit fixation. The implaFit® hip stems cemented are intended for cemented fixation.

Source page: https://510kreport.com/device/K210678
Methodology: https://510kreport.com/methodology