510(k) · Cleared

Cleared

Icona Hip Stem

K241472510(k) TraditionalCleared Oct 3, 2024132-day reviewClass II21 CFR 888.3353

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Corin U.S.A. Limited · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Cleared on Oct 3, 2024 as substantially equivalent to K150862 (DePuy Orthopaedics, Inc., 2015) and 7 other predicates after a 132-day review. Its family tree reaches back 18 generations to 1981. 1 of the 420 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.

Decided: Oct 3, 2024
Review: 132 days
Class: Class II
Product code: MEH
Recalls: None
Predicates: 8

Its longest line of descent runs back 18 generations to K810258 (1981). 419 ancestors in all, the oldest K800207 (1980). 1 later device descends from it, 1 citing it directly. 1 of the 420 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 18 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
14 generations between
3 generations backK131952 Corin Metafix Hip StemCorin USA · 2013
2 generations backK162942 Corin MetaFix Hip StemCorin U.S.A. Limited · 2017
1 generation backK212069 Corin MetaFix™ Hip StemCorin U.S.A. Limited · 2022
This deviceK241472 Icona Hip StemCorin U.S.A. Limited · 2024
Descendant · cites it directly · 0 of its ownK261576 Icona Hip StemCorin, Ltd. · 2026

Show all 18 generations

Root · 18 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
17 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
16 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
15 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
14 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
13 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
12 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
11 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
10 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
9 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
8 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
7 generations backK111911 Corin Optimom Modular HeadCorin USA · 2011
6 generations backK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
5 generations backK121439 Metafix Femoral Hip Stem Size 1Corin USA · 2012
4 generations backK130634 Corin Metafix Hip StemCorin USA · 2013
3 generations backK131952 Corin Metafix Hip StemCorin USA · 2013
2 generations backK162942 Corin MetaFix Hip StemCorin U.S.A. Limited · 2017
1 generation backK212069 Corin MetaFix™ Hip StemCorin U.S.A. Limited · 2022
This deviceK241472 Icona Hip StemCorin U.S.A. Limited · 2024

Class I recalls in this family

K091423 Profemur Hip System Modular Necks4 generations back · 2009

Most influential descendants

Showing 1 of 1 · See all

K261576Icona Hip StemCorin, Ltd. · 2026 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−18	K810258	Proximal Fermoral Hip Replacement	Biomet, Inc.	1981	—
−17	K974558	Salvage/Onocology Hip and Total Femur System	Biomet, Inc.	1998	—
−16	K032396	Ringloc 36MM Line and Modular Femoral Heads	Biomet, Inc.	2003	3
−15	K042051	Arcomxl Polyethylene Liners	Biomet, Inc.	2005	1
−14	K051411	Arcomxl Polyethylene Liners and Biolox Delta Heads	Biomet, Inc.	2005	1
−13	K061312	36MM Biolox Delta Ceramic Heads	Biomet, Inc.	2006	—
−12	K071535	Biolox Delta Ceramic Femoral Head	Zimmer, Inc.	2007	3
−11	K082844	Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset…	Encore Medical L.P.	2008	1
−10	K100412	Biolox Delta Ceramic Femoral Heads	Smith & Nephew, Inc.	2010	—
−9	K103120	Corin Biolox Delta Femoral Heads	Corin USA	2011	—
−8	K110087	Corin Trinity Acetbular System with Hxlpe Liners	Corin USA	2011	—
−7	K111911	Corin Optimom Modular Head	Corin USA	2011	—
−6	K120362	Metafix Femoral Stem for Hemi-Arthroplasty	Corin USA	2012	—
−5	K121439	Metafix Femoral Hip Stem Size 1	Corin USA	2012	—
−4	K130634	Corin Metafix Hip Stem	Corin USA	2013	—
−3	K131952	Corin Metafix Hip Stem	Corin USA	2013	—
−2	K162942	Corin MetaFix Hip Stem	Corin U.S.A. Limited	2017	—
−1	K212069	Corin MetaFix™ Hip Stem	Corin U.S.A. Limited	2022	—
0 (this device)	K241472	Icona Hip Stem	Corin U.S.A. Limited	2024	—
+1	K261576	Icona Hip Stem	Corin, Ltd.	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1980	1	0
1981	1	0
1983	3	0
1984	1	0
1985	4	0
1986	6	0
1987	3	0
1988	3	0
1989	1	0
1990	5	0
1991	7	0
1992	7	0
1993	8	0
1994	34	0
1995	23	0
1996	23	0
1997	21	0
1998	17	0
1999	17	0
2000	34	0
2001	18	0
2002	19	0
2003	21	0
2004	13	0
2005	17	0
2006	9	0
2007	14	0
2008	7	0
2009	11	1
2010	14	0
2011	9	0
2012	7	0
2013	6	0
2014	2	0
2015	3	0
2016	4	0
2017	1	0
2018	2	0
2019	2	0
2020	1	0
2021	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2026	1	0

FIG. 1 — Lineage of K241472, 1981–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MEH device

#1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (8)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K150862	DePuy Actis Duofox Hip Prosthesis Summary page 5 …21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code K150862 Actis DuoFix Hip Prosthesis MEH K173880…	DePuy Orthopaedics, Inc.	2015	1
*	K173880	Corin TriFit CF Hip Stem Summary page 5 …Product Code K150862 Actis DuoFix Hip Prosthesis MEH K173880 TriFit CF Hip Stem MEH K201657…	Corin U.S.A. Limited	2018	—
*	K201657	Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell… Summary page 5 …MEH K173880 TriFit CF Hip Stem MEH K201657 OMNI MOD Hip System LZO K212069…	Corin, Ltd.	2021	—
*	K212069	Corin MetaFix™ Hip Stem Summary page 5 …MEH K201657 OMNI MOD Hip System LZO K212069 Metafix Hip Stem LZO Device Des…	Corin U.S.A. Limited	2022	—
*	K082525	Corin Metafix Femoral Stem Summary page 6 …21 CFR 807.92(a)(5) The lcona Hip Stem is substantially equivalent to Actis DuoFix Hip Prosthesis (Kl 50862), TriFit CF Hip Stem (Kl 73880), Metafix Hip Stem (K082525, K121439, Kl 53381, K212069), OMNI MOD Hip Stem (K000788, K201657) in terms of intended use and indications, with the exception o…	Corin USA	2010	2
*	K121439	Metafix Femoral Hip Stem Size 1 Summary page 6 …21 CFR 807.92(a)(5) The lcona Hip Stem is substantially equivalent to Actis DuoFix Hip Prosthesis (Kl 50862), TriFit CF Hip Stem (Kl 73880), Metafix Hip Stem (K082525, K121439, Kl 53381, K212069), OMNI MOD Hip Stem (K000788, K201657) in terms of intended use and indications, with the exception of OMNI MO…	Corin USA	2012	—
*	K153381	Corin Metafix Hip Stem Summary page 6 …m alloy - Ti6Al4V), neck geometry and finish. The lcona Hip Stem is substantially equivalent to previously cleared predicate device Meta Fix Hip Stem (K082525, K121439, K153381, K212069) in terms of intended use, indications, material (titanium alloy - Ti6Al4V), neck geometry, taper design and packaging.…	Corin U.S.A. Limited	2016	1
*	K000788	Apex Modular Hip Stem Summary page 6 …tantially equivalent to Actis DuoFix Hip Prosthesis (Kl 50862), TriFit CF Hip Stem (Kl 73880), Metafix Hip Stem (K082525, K121439, Kl 53381, K212069), OMNI MOD Hip Stem (K000788, K201657) in terms of intended use and indications, with the exception of OMNI MOD Hip Stem which is also indicated for revision.…	Apex Surgical, LLC	2000	—

Also cleared against K150862: 13 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K261576	Icona Hip Stem	Corin, Ltd.	2026	0

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K091423Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2009 · 4 generations back · ◆ in the 2009 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 43 years and passes through 6 companies; a new generation was cleared every 1.0 years on median.
104 of the 418 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K261576 (Corin, Ltd., 2026) has gone furthest, with 0 descendants of its own.
13 other devices also cite its predicate K150862.

How does its category compare?

All MEH devices

MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · MEH

5in 2025

2007high 6 (2008) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MEH

87in 2025

2007high 226 (2010) · low 65 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MEH

1in 2025

2007high 80 (2008) · low 0 (2013)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MEH

470in 2025

2007high 1,606 (2012) · low 25 (2007)2025

MAUDE reports naming product code MEH, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	3	25
2008	6	79	80	261
2009	6	65	51	539
2010	5	226	16	462
2011	5	95	4	419
2012	6	131	3	1,606
2013	1	—	0	1,295
2014	0	—	1	1,196
2015	2	—	1	490
2016	6	163	4	347
2017	3	209	1	383
2018	2	—	3	337
2019	1	—	0	335
2020	3	131	1	338
2021	3	83	0	372
2022	3	150	0	316
2023	2	—	0	334
2024	6	91	0	354
2025	5	87	1	470
2026	1	—	1	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K241472 · printed Nov 6, 2026

Cite this page

510(k) Report. “K241472: Icona Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241472

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026