510(k) · Cleared
ClearedMetafix Femoral Hip Stem Size 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin USA · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Sep 14, 2012 as substantially equivalent to K082525 (Corin USA, 2010) and 1 other predicate after a 122-day review. Its family tree reaches back 13 generations to 1981. 8 later devices descend from it.
- Decided
- Sep 14, 2012
- Review
- 122 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K810258 (1981). 120 ancestors in all. 8 later devices descend from it, 7 citing it directly.
- Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 9 generations between
- 3 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 2 generations backK111911 Corin Optimom Modular HeadCorin USA · 2011
- 1 generation backK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
- This deviceK121439 Metafix Femoral Hip Stem Size 1Corin USA · 2012
- Descendant · cites it directly · 5 of its ownK153381 Corin Metafix Hip StemCorin U.S.A. Limited · 2016 · Recalled
- Descendant · cites it directly · 5 of its ownK130634 Corin Metafix Hip StemCorin USA · 2013
- Descendant · cites it directly · 4 of its ownK131952 Corin Metafix Hip StemCorin USA · 2013
- 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
Show all 13 generations
- Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 12 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 11 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 10 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 9 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 8 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 7 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 6 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 5 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 4 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 3 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 2 generations backK111911 Corin Optimom Modular HeadCorin USA · 2011
- 1 generation backK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
- This deviceK121439 Metafix Femoral Hip Stem Size 1Corin USA · 2012
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K153381Corin Metafix Hip StemCorin U.S.A. Limited · 2016 · cites it directly5descendants
- K130634Corin Metafix Hip StemCorin USA · 2013 · cites it directly5descendants
- K131952Corin Metafix Hip StemCorin USA · 2013 · cites it directly4descendants
- K162942Corin MetaFix Hip StemCorin U.S.A. Limited · 2017 · cites it directly3descendants
- K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited · 2022 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −12 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −11 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −10 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −9 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −8 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −7 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −6 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −5 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −4 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| −3 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| −2 | K111911 | Corin Optimom Modular Head | Corin USA | 2011 | — |
| −1 | K120362 | Metafix Femoral Stem for Hemi-Arthroplasty | Corin USA | 2012 | — |
| 0 (this device) | K121439 | Metafix Femoral Hip Stem Size 1 | Corin USA | 2012 | — |
| +1 | K153381 | Corin Metafix Hip Stem | Corin U.S.A. Limited | 2016 | 1 |
| +1 | K130634 | Corin Metafix Hip Stem | Corin USA | 2013 | — |
| +1 | K131952 | Corin Metafix Hip Stem | Corin USA | 2013 | — |
| +1 | K162942 | Corin MetaFix Hip Stem | Corin U.S.A. Limited | 2017 | — |
| +1 | K212069 | Corin MetaFix™ Hip Stem | Corin U.S.A. Limited | 2022 | — |
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 | 12 | 0 |
| 2001 | 6 | 0 |
| 2002 | 8 | 0 |
| 2003 | 3 | 0 |
| 2004 | 6 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K082525 | Corin Metafix Femoral StemSummary page 1…etal/polymer semi-constrained cemented prosthesis. (21CFR 888.3350) 8. Legally Matketed Devices to which Substantial Equivalence is claimed: ® Corin Merafix Hip Stem (K082525) ® Corin Metafix Hip Stem with Hemi-Arthroplasty (K120362) Paga 6 of 119 4 20 K11 939 pacE ) oF S The Corin M… | 2010 |
| * | K120362 | Metafix Femoral Stem for Hemi-ArthroplastySummary page 1…888.3350) 8. Legally Matketed Devices to which Substantial Equivalence is claimed: ® Corin Merafix Hip Stem (K082525) ® Corin Metafix Hip Stem with Hemi-Arthroplasty (K120362) Paga 6 of 119 4 20 K11 939 pacE ) oF S The Corin Metafix Hip Stem is a titanium femorel hip stem featuring a… | 2012 |
What descends from it? (8)
7 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153381 | Corin Metafix Hip Stem | 2016 | 5 |
| K130634 | Corin Metafix Hip Stem | 2013 | 5 |
| K131952 | Corin Metafix Hip Stem | 2013 | 4 |
| K162942 | Corin MetaFix Hip Stem | 2017 | 3 |
| K212069 | Corin MetaFix™ Hip Stem | 2022 | 2 |
| K201657 | Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell… | 2021 | 2 |
| 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 31 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 28 of the 119 ancestors have a recall of any class.
- Of its descendants, K153381 (Corin U.S.A. Limited, 2016) has gone furthest, with 5 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. 2012, 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) and congenital dysplasia of the hip (CDH)
The Corin Metafix Hip Stem is indicated for cementless 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/K121439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121439: Metafix Femoral Hip Stem Size 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121439
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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