# K241472: Icona Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Corin U.S.A. Limited
- Decided: Oct 3, 2024 after 132 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: 18 generations back to K810258 (1981). 419 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 420 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150862: DePuy Actis Duofox Hip Prosthesis, DePuy Orthopaedics, Inc. (2015) Summary page 5.
- K173880: Corin TriFit CF Hip Stem, Corin U.S.A. Limited (2018) Summary page 5.
- K201657: Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads, Corin, Ltd. (2021) Summary page 5.
- K212069: Corin MetaFix™ Hip Stem, Corin U.S.A. Limited (2022) Summary page 5.
- K082525: Corin Metafix Femoral Stem, Corin USA (2010) Summary page 6.
- K121439: Metafix Femoral Hip Stem Size 1, Corin USA (2012) Summary page 6.
- K153381: Corin Metafix Hip Stem, Corin U.S.A. Limited (2016) Summary page 6.
- K000788: Apex Modular Hip Stem, Apex Surgical, LLC (2000) Summary page 6.

## Most influential descendants
- K261576: Icona Hip Stem (2026), 0 descendants of its own

## Indications for use
The indications for the Corin 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/K241472
Methodology: https://510kreport.com/methodology