# K261576: Icona Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Corin, Ltd.
- Decided: Aug 10, 2026 after 90 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- 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: 19 generations back to K810258 (1981). 421 ancestors in all.
No later device cites it as a predicate yet.
1 of 421 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241472: Icona Hip Stem, Corin U.S.A. Limited (2024) Summary page 5.
- K160907: DePuy Actis DuoFix Hip Prosthesis, Depuy (Ireland) (2016) Summary page 5.

## Indications for use
The indications for the Icona Hip Stem as a total hip arthroplasty, and when used in combination with a Corin hemiarthroplasty head, as a hip hemiarthroplasty, include: • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis • Rheumatoid arthritis • Correction of functional deformity • Treatment of non-union and femoral neck fractures • Developmental dysplasia of the hip (DDH) / congenital dysplasia of the hip (CDH) The Corin Icona Hip Stem is indicated for cementless use only.

Source page: https://510kreport.com/device/K261576
Methodology: https://510kreport.com/methodology