510(k) · Cleared
ClearedIcona Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin, Ltd. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Aug 10, 2026 as substantially equivalent to K241472 (Corin U.S.A. Limited, 2024) and 1 other predicate after a 90-day review. Its family tree reaches back 19 generations to 1981. 1 of the 421 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 10, 2026
- Review
- 90 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K810258 (1981). 421 ancestors in all, the oldest K800207 (1980). No later device cites it as a predicate yet. 1 of the 421 devices in this family, counting this one, has a Class I recall.
- Root · 19 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 15 generations between
- 3 generations backK162942 Corin MetaFix Hip StemCorin U.S.A. Limited · 2017
- 2 generations backK212069 Corin MetaFix™ Hip StemCorin U.S.A. Limited · 2022
- 1 generation backK241472 Icona Hip StemCorin U.S.A. Limited · 2024
- This deviceK261576 Icona Hip StemCorin, Ltd. · 2026
Show all 19 generations
- Root · 19 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 18 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 17 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 16 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 15 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 14 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 13 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 12 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 11 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 10 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 9 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 8 generations backK111911 Corin Optimom Modular HeadCorin USA · 2011
- 7 generations backK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
- 6 generations backK121439 Metafix Femoral Hip Stem Size 1Corin USA · 2012
- 5 generations backK130634 Corin Metafix Hip StemCorin USA · 2013
- 4 generations backK131952 Corin Metafix Hip StemCorin USA · 2013
- 3 generations backK162942 Corin MetaFix Hip StemCorin U.S.A. Limited · 2017
- 2 generations backK212069 Corin MetaFix™ Hip StemCorin U.S.A. Limited · 2022
- 1 generation backK241472 Icona Hip StemCorin U.S.A. Limited · 2024
- This deviceK261576 Icona Hip StemCorin, Ltd. · 2026
Class I recalls in this family
- K091423 Profemur Hip System Modular Necks5 generations back · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −18 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −17 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −16 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −15 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −14 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −13 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −12 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −11 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −10 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| −9 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| −8 | K111911 | Corin Optimom Modular Head | Corin USA | 2011 | — |
| −7 | K120362 | Metafix Femoral Stem for Hemi-Arthroplasty | Corin USA | 2012 | — |
| −6 | K121439 | Metafix Femoral Hip Stem Size 1 | Corin USA | 2012 | — |
| −5 | K130634 | Corin Metafix Hip Stem | Corin USA | 2013 | — |
| −4 | K131952 | Corin Metafix Hip Stem | Corin USA | 2013 | — |
| −3 | K162942 | Corin MetaFix Hip Stem | Corin U.S.A. Limited | 2017 | — |
| −2 | K212069 | Corin MetaFix™ Hip Stem | Corin U.S.A. Limited | 2022 | — |
| −1 | K241472 | Icona Hip Stem | Corin U.S.A. Limited | 2024 | — |
| 0 (this device) | 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 | 5 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K241472 | Icona Hip StemSummary page 5…prosthesis Regulation Number: 888.3353 Product Code(s): MEH, KWL, KWY, LZO 3. LEGALLY MARKETED PREDICATES Predicate 510(k) Predicate Trade Name K241472 Icona Hip Stem K160907 Actis DuoFix Hip Prosthesis 4. DEVICE DESCRIP… | 2024 |
| * | K160907 | DePuy Actis DuoFix Hip ProsthesisSummary page 5…(s): MEH, KWL, KWY, LZO 3. LEGALLY MARKETED PREDICATES Predicate 510(k) Predicate Trade Name K241472 Icona Hip Stem K160907 Actis DuoFix Hip Prosthesis 4. DEVICE DESCRIPTION SUMMARY The Corin Icona Hip Stem is a tapered… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 5 generations back · ◆ in the 2009 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 45 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
- 104 of the 420 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 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 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/K261576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261576: 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/K261576
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026