510(k) · Cleared
Recalled · Class II · 2018Corail Amt Hip Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Feb 11, 2005 as substantially equivalent to K953111 (Landos, Inc., 1996) and 1 other predicate after a 102-day review. Its family tree reaches back 5 generations to 1994. 168 later devices descend from it. It has been recalled once.
- Decided
- Feb 11, 2005
- Review
- 102 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K935452 (1994). 15 ancestors in all, the oldest K851422 (1985). 168 later devices descend from it, 27 citing it directly.
- Root · 5 generations backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
- 4 generations backK945518 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996
- 3 generations backK961939 S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996
- 2 generations backK974331 Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998
- 1 generation backK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
- This deviceK042992 Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005
- Descendant · cites it directly · 71 of its ownK082525 Corin Metafix Femoral StemCorin USA · 2010 · Recalled
- Descendant · 2 generations on · 61 of its ownK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
- Descendant · cites it directly · 49 of its ownK070554 Depuy Corail Amt Dysplasia Hip ProsthesisDePuy Orthopaedics, Inc. · 2007
- Descendant · cites it directly · 48 of its ownK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- Descendant · cites it directly · 41 of its ownK123392 Avenir Muller StemZimmer GmbH · 2013 · Recalled
Showing 5 of 168 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 168 · See all- K082525Corin Metafix Femoral StemCorin USA · 2010 · cites it directly71descendants
- K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012 · 2 generations on61descendants
- K070554Depuy Corail Amt Dysplasia Hip ProsthesisDePuy Orthopaedics, Inc. · 2007 · cites it directly49descendants
- K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · cites it directly48descendants
- K123392Avenir Muller StemZimmer GmbH · 2013 · cites it directly41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K935452 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Orthopaedics, Inc. | 1994 | — |
| −4 | K945518 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −3 | K961939 | S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115) | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −2 | K974331 | Uni-Rom Total Hip System Femoral Stem | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −1 | K001991 | Titan Porocoat Hip Prosthesis | DePuy Orthopaedics, Inc. | 2000 | — |
| 0 (this device) | K042992 | Corail Amt Hip Prosthesis | DePuy Orthopaedics, Inc. | 2005 | — |
| +1 | K082525 | Corin Metafix Femoral Stem | Corin USA | 2010 | 2 |
| +2 | K120362 | Metafix Femoral Stem for Hemi-Arthroplasty | Corin USA | 2012 | — |
| +1 | K070554 | Depuy Corail Amt Dysplasia Hip Prosthesis | DePuy Orthopaedics, Inc. | 2007 | — |
| +1 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| +1 | K123392 | Avenir Muller Stem | Zimmer GmbH | 2013 | 4 |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 10 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 6 | 0 |
| 2017 | 10 | 0 |
| 2018 | 12 | 0 |
| 2019 | 12 | 0 |
| 2020 | 13 | 0 |
| 2021 | 8 | 0 |
| 2022 | 12 | 0 |
| 2023 | 19 | 0 |
| 2024 | 15 | 0 |
| 2025 | 17 | 0 |
| 2026 | 14 | 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 |
|---|---|---|---|
| * | K953111 | CorailSummary page 1…component, prosthesis Substantially Equivalent Device: HA Coating Defty CorailO K.953111 Hip stem DePuy TitantU K001991… | 1996 |
| * | K001991 | Titan Porocoat Hip ProsthesisSummary page 1…Defty CorailO K.953111 Hip stem DePuy TitantU K001991 (Marketed by name Summit TM ) Device Descriptions: The Coradl AMT Hip is a tape… | 2000 |
What descends from it? (168)
See all 16827 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082525 | Corin Metafix Femoral Stem | 2010 | 71 |
| K070554 | Depuy Corail Amt Dysplasia Hip Prosthesis | 2007 | 49 |
| K123991 | Depuy Corail Amt Hip Prosthesis | 2013 | 48 |
| K123392 | Avenir Muller Stem | 2013 | 41 |
| K121297 | Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series… | 2012 | 20 |
| K162719 | iTotal® Hip Replacement System | 2017 | 17 |
| K093736 | Depuy Corail Hip System, Revision Stem | 2011 | 14 |
| K192946 | DePuy Corail AMT Hip Prosthesis | 2019 | 10 |
| K211657 | EMPHASYS Femoral Stems | 2021 | 7 |
| K190904 | Conformis BeneFIT Hip System | 2019 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 21, 2018 | Class II | Z-2521-2018 | Process control | Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional surgical procedure to correct. It may also result in an… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K082525 (Corin USA, 2010) has gone furthest, with 71 descendants of its own.
- 9 other devices also cite its predicate K953111.
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.
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?
Total hip arthroplasty is intended to provide increased patieat mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the comnponects. Total hip replacement is indicated in the following conditions: 1. A severely painful sndlor disabled joint from ostcoarthritis, traumatic afritis, rheunatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of…
Read the full statement (115 words)
Total hip arthroplasty is intended to provide increased patieat mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the comnponects. Total hip replacement is indicated in the following conditions:
1. A severely painful sndlor disabled joint from ostcoarthritis, traumatic afritis, rheunatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3 Acute traumatic fracture of the f£nnoral head or neck
4. Failed previous hip surgery including joint rxconstmotion, internal fixation, artfindesis, bcmiarthroplasty, surface xeplacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
The non-porous Corail AMT Ilip Stem is indicated for cemnentless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042992 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042992: Corail Amt Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042992
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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