510(k) · Cleared
Recalled · Class II · 2022Corin 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 Jan 21, 2016 as substantially equivalent to K082525 (Corin USA, 2010) and 4 other predicates after a 59-day review. Its family tree reaches back 14 generations to 1981. 5 later devices descend from it. It has been recalled once.
- Decided
- Jan 21, 2016
- Review
- 59 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 14 generations to K810258 (1981). 127 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 14 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 10 generations between
- 3 generations backK111911 Corin Optimom Modular HeadCorin USA · 2011
- 2 generations backK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
- 1 generation backK121439 Metafix Femoral Hip Stem Size 1Corin USA · 2012
- This deviceK153381 Corin Metafix Hip StemCorin U.S.A. Limited · 2016
- Descendant · cites it directly · 3 of its ownK162942 Corin MetaFix Hip StemCorin U.S.A. Limited · 2017
- Descendant · cites it directly · 2 of its ownK212069 Corin MetaFix™ Hip StemCorin U.S.A. Limited · 2022
- Descendant · cites it directly · 2 of its ownK201657 Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS…Corin, Ltd. · 2021
- 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 14 generations
- Root · 14 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 13 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 12 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 11 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 10 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 9 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 8 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 7 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 6 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 5 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 4 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 3 generations backK111911 Corin Optimom Modular HeadCorin USA · 2011
- 2 generations backK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
- 1 generation backK121439 Metafix Femoral Hip Stem Size 1Corin USA · 2012
- This deviceK153381 Corin Metafix Hip StemCorin U.S.A. Limited · 2016
Most influential descendants
Showing 5 of 5 · See all- K162942Corin MetaFix Hip StemCorin U.S.A. Limited · 2017 · cites it directly3descendants
- K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited · 2022 · cites it directly2descendants
- K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd. · 2021 · cites it directly2descendants
- K241472Icona Hip StemCorin U.S.A. Limited · 2024 · cites it directly1descendant
- K261576Icona Hip StemCorin, Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −13 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −12 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −11 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −10 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −9 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −8 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −7 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −6 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −5 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| −4 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| −3 | K111911 | Corin Optimom Modular Head | Corin USA | 2011 | — |
| −2 | K120362 | Metafix Femoral Stem for Hemi-Arthroplasty | Corin USA | 2012 | — |
| −1 | K121439 | Metafix Femoral Hip Stem Size 1 | Corin USA | 2012 | — |
| 0 (this device) | K153381 | Corin Metafix Hip Stem | Corin U.S.A. Limited | 2016 | — |
| +1 | K162942 | Corin MetaFix Hip Stem | Corin U.S.A. Limited | 2017 | — |
| +1 | K212069 | Corin MetaFix™ Hip Stem | Corin U.S.A. Limited | 2022 | — |
| +1 | K201657 | Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular… | Corin, Ltd. | 2021 | — |
| +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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 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…(21CFR 888.3350) 8. Legally Marketed Devices to which Substantial Equivalence is claimed: Corin Metafix Hip Stem (K082525, K121439 & K120362) Depuy Orthopaedics Corail AMT Hip System (K042992)… | 2010 |
| * | 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, K121439 & K120362) Depuy Orthopaedics Corail AMT Hip System (K042992) Corin… | 2012 |
| * | 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, K121439 & K120362) Depuy Orthopaedics Corail AMT Hip System (K042992) Corin TriFit TS… | 2012 |
| * | K042992 | Corail Amt Hip ProsthesisSummary page 4…e is claimed: Corin Metafix Hip Stem (K082525, K121439 & K120362) Depuy Orthopaedics Corail AMT Hip System (K042992) Corin TriFit TS Hip Stem (K121563)… | 2005 |
| * | K121563 | Corin Trifit TS HipSummary page 4…m (K082525, K121439 & K120362) Depuy Orthopaedics Corail AMT Hip System (K042992) Corin TriFit TS Hip Stem (K121563) K153381 Page 2 of 3 9.… | 2012 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 22, 2022 | Class II | Z-1509-2022 | Process control | One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 6 companies; a new generation was cleared every 1.0 years on median.
- 29 of the 126 ancestors have a recall of any class.
- Of its descendants, K162942 (Corin U.S.A. Limited, 2017) has gone furthest, with 3 descendants 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. 2016, 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 Corin hemi-arthroplasty femoral heads, as a hemi-arthroplasty, include:
Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur
Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
The Corin Metafix Hip Stem is intended for cementless, single use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153381: 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/K153381
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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