510(k) · Cleared
ClearedCorin MetaFix™ Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin U.S.A. Limited · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Apr 7, 2022 as substantially equivalent to K082525 (Corin USA, 2010) and 4 other predicates after a 279-day review. Its family tree reaches back 17 generations to 1981. 2 later devices descend from it.
- Decided
- Apr 7, 2022
- Review
- 279 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 17 generations to K810258 (1981). 132 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 17 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 13 generations between
- 3 generations backK130634 Corin Metafix Hip StemCorin USA · 2013
- 2 generations backK131952 Corin Metafix Hip StemCorin USA · 2013
- 1 generation backK162942 Corin MetaFix Hip StemCorin U.S.A. Limited · 2017
- This deviceK212069 Corin MetaFix™ Hip StemCorin U.S.A. Limited · 2022
- Descendant · cites it directly · 1 of its ownK241472 Icona Hip StemCorin U.S.A. Limited · 2024
- Descendant · 2 generations on · 0 of its ownK261576 Icona Hip StemCorin, Ltd. · 2026
Show all 17 generations
- Root · 17 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 16 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 15 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 14 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 13 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 12 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 11 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 10 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 9 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 8 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 7 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 6 generations backK111911 Corin Optimom Modular HeadCorin USA · 2011
- 5 generations backK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
- 4 generations backK121439 Metafix Femoral Hip Stem Size 1Corin USA · 2012
- 3 generations backK130634 Corin Metafix Hip StemCorin USA · 2013
- 2 generations backK131952 Corin Metafix Hip StemCorin USA · 2013
- 1 generation backK162942 Corin MetaFix Hip StemCorin U.S.A. Limited · 2017
- This deviceK212069 Corin MetaFix™ Hip StemCorin U.S.A. Limited · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −16 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −15 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −14 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −13 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −12 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −11 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −10 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −9 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −8 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| −7 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| −6 | K111911 | Corin Optimom Modular Head | Corin USA | 2011 | — |
| −5 | K120362 | Metafix Femoral Stem for Hemi-Arthroplasty | Corin USA | 2012 | — |
| −4 | K121439 | Metafix Femoral Hip Stem Size 1 | Corin USA | 2012 | — |
| −3 | K130634 | Corin Metafix Hip Stem | Corin USA | 2013 | — |
| −2 | K131952 | Corin Metafix Hip Stem | Corin USA | 2013 | — |
| −1 | K162942 | Corin MetaFix Hip Stem | Corin U.S.A. Limited | 2017 | — |
| 0 (this device) | K212069 | Corin MetaFix™ Hip Stem | Corin U.S.A. Limited | 2022 | — |
| +1 | K241472 | Icona Hip Stem | Corin U.S.A. Limited | 2024 | — |
| +2 | K261576 | Icona Hip Stem | Corin, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 4 | 0 |
| 1993 | 4 | 0 |
| 1994 | 15 | 0 |
| 1995 | 6 | 0 |
| 1996 | 9 | 0 |
| 1997 | 6 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 13 | 0 |
| 2001 | 7 | 0 |
| 2002 | 8 | 0 |
| 2003 | 3 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 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.
Planning a device in LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K082525 | Corin Metafix Femoral StemSummary page 4…d prosthesis. (21CFR 888.3350) 8. Legally Marketed Devices to which Substantial Equivalence is claimed: • Corin MetaFix Hip Stem (K082525 (primary predicate), K120362, K121439, K153381 & K162942)… | 2010 |
| * | K120362 | Metafix Femoral Stem for Hemi-ArthroplastySummary page 4…(21CFR 888.3350) 8. Legally Marketed Devices to which Substantial Equivalence is claimed: • Corin MetaFix Hip Stem (K082525 (primary predicate), K120362, K121439, K153381 & K162942)… | 2012 |
| * | K121439 | Metafix Femoral Hip Stem Size 1Summary page 4…(21CFR 888.3350) 8. Legally Marketed Devices to which Substantial Equivalence is claimed: • Corin MetaFix Hip Stem (K082525 (primary predicate), K120362, K121439, K153381 & K162942)… | 2012 |
| * | K153381 | Corin Metafix Hip StemSummary page 4…CFR 888.3350) 8. Legally Marketed Devices to which Substantial Equivalence is claimed: • Corin MetaFix Hip Stem (K082525 (primary predicate), K120362, K121439, K153381 & K162942) K212069… | 2016 |
| * | K162942 | Corin MetaFix Hip StemSummary page 4…50) 8. Legally Marketed Devices to which Substantial Equivalence is claimed: • Corin MetaFix Hip Stem (K082525 (primary predicate), K120362, K121439, K153381 & K162942) K212069… | 2017 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241472 | Icona Hip Stem | 2024 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 41 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 31 of the 131 ancestors have a recall of any class.
- Of its descendants, K241472 (Corin U.S.A. Limited, 2024) has gone furthest, with 1 descendant of its own.
- 9 other devices also cite its predicate K082525.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
The indications for the Corin MetaFix™ Hip Stem as a total hip arthroplasty, and when used in combination with a Corin hemi-arthroplasty head, as a hip hemi-arthroplasty, 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) and congenital dysplasia of the hip (CDH)
The Corin MetaFix™ Hip Stem is indicated for cementless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212069 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212069: Corin MetaFix™ 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/K212069
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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