# K232371: Actinia® hip stems

- Pathway: 510(k) (Traditional)
- Applicant: Implantcast GmbH
- Decided: Oct 19, 2023 after 72 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.
1 later device descends from it; 1 cites it directly.
0 of 347 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 6.

## Most influential descendants
- K260037: implantcast Packaging System Update (2026), 0 descendants of its own

## Indications for use
The Actinia® hip 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 Actinia® hip stems cementless are intended for uncemented, press-fit fixation. The Actinia® hip 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/K232371
Methodology: https://510kreport.com/methodology