510(k) · Cleared
Recalled · Class II · 2022Corin Metafix Femoral Stem
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 Feb 4, 2010 as substantially equivalent to K042992 (DePuy Orthopaedics, Inc., 2005) after a 520-day review. Its family tree reaches back 6 generations to 1994. 71 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 4, 2010
- Review
- 520 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 6 generations to K935452 (1994). 16 ancestors in all, the oldest K851422 (1985). 71 later devices descend from it, 10 citing it directly.
- Root · 6 generations backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
- 5 generations backK945518 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996
- 4 generations backK961939 S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996
- 3 generations backK974331 Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998
- 2 generations backK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
- 1 generation backK042992 Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · Recalled
- This deviceK082525 Corin Metafix Femoral StemCorin USA · 2010
- Descendant · cites it directly · 61 of its ownK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
- Descendant · 2 generations on · 48 of its ownK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- Descendant · 3 generations on · 38 of its ownK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 27 of its ownK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
- Descendant · 4 generations on · 26 of its ownK160907 DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland) · 2016
Showing 5 of 71 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 71 · See all- K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012 · cites it directly61descendants
- K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · 2 generations on48descendants
- K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · 3 generations on38descendants
- K170339Summit Hip SystemDePuy Orthopaedics, Inc. · 2018 · 3 generations on27descendants
- K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland) · 2016 · 4 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K935452 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Orthopaedics, Inc. | 1994 | — |
| −5 | K945518 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −4 | K961939 | S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115) | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −3 | K974331 | Uni-Rom Total Hip System Femoral Stem | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −2 | K001991 | Titan Porocoat Hip Prosthesis | DePuy Orthopaedics, Inc. | 2000 | — |
| −1 | K042992 | Corail Amt Hip Prosthesis | DePuy Orthopaedics, Inc. | 2005 | 1 |
| 0 (this device) | K082525 | Corin Metafix Femoral Stem | Corin USA | 2010 | — |
| +1 | K120362 | Metafix Femoral Stem for Hemi-Arthroplasty | Corin USA | 2012 | — |
| +2 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| +3 | K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 | 1 |
| +3 | K170339 | Summit Hip System | DePuy Orthopaedics, Inc. | 2018 | — |
| +4 | K160907 | DePuy Actis DuoFix Hip Prosthesis | Depuy (Ireland) | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 10 | 0 |
| 2026 | 8 | 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? (1)
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 |
|---|---|---|---|
| * | K042992 | Corail Amt Hip ProsthesisSummary page 1…3350) 6. Product Code: LZO, JDI 7. Legally Marketed Devices to which Substantial Equivalence is claimed: a. Depuy Orthopaedics Corail AMTf Hip System (1K042992) 8. Device Description: The Corin Metafix Hlip Stem is a titanium femoral hip stem featuring a 12/14 tapered m… | 2005 |
What descends from it? (71)
See all 7110 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120362 | Metafix Femoral Stem for Hemi-Arthroplasty | 2012 | 61 |
| K121439 | Metafix Femoral Hip Stem Size 1 | 2012 | 8 |
| K103518 | Trinity Acetabular System | 2011 | 8 |
| 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)
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. |
| Jul 28, 2021 | Class II | Z-2609-2021 | Storage | The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K120362 (Corin USA, 2012) has gone furthest, with 61 descendants of its own.
- 26 other devices also cite its predicate K042992.
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. 2010, 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 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
DDH/CDH
The Corin Metafix Hip Stern is indicated for cemtentless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082525: Corin Metafix Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082525
Report an extraction error
Are you the manufacturer?
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