# K252401: implaFit® short stems

- Pathway: 510(k) (Traditional)
- Applicant: Implantcast GmbH
- Decided: Mar 12, 2026 after 224 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: 18 generations back to K941847 (1994). 346 ancestors in all.
No later device cites it as a predicate yet.
0 of 346 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210678: implaFit® hip stems, Implantcast GmbH (2022) Summary page 5.

## Indications for use
The implaFit® short 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 implaFit® short stems are intended for uncemented, press-fit fixation. The implaFit® short 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/K252401
Methodology: https://510kreport.com/methodology