510(k) · Cleared
ClearedDePuy Corail AMT Hip Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy (Ireland) · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Nov 1, 2019 as substantially equivalent to K173960 (Depuy France S.A.S., 2018) and 1 other predicate after a 260-day review. Its family tree reaches back 15 generations to 1994. 11 later devices descend from it.
- Decided
- Nov 1, 2019
- Review
- 260 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K941847 (1994). 175 ancestors in all, the oldest K810258 (1981). 11 later devices descend from it, 3 citing it directly.
- Root · 15 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 11 generations between
- 3 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- 2 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- 1 generation backK173960 DePuy Corail AMT Hip ProsthesisDepuy France S.A.S. · 2018
- This deviceK190344 DePuy Corail AMT Hip ProsthesisDepuy (Ireland) · 2019
- Descendant · cites it directly · 7 of its ownK211657 EMPHASYS Femoral StemsDepuy Ireland UC · 2021
- Descendant · 2 generations on · 5 of its ownK231873 DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT…Depuy Ireland UC · 2024
- Descendant · 3 generations on · 1 of its ownK251292 RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC · 2025
- Descendant · 3 generations on · 1 of its ownK243977 EMPHASYS Acetabular SystemDepuy Ireland UC · 2025
- Descendant · cites it directly · 1 of its ownK223745 Novae® Dual Mobility System, Hype® Hip SystemSerf · 2023
Show all 15 generations
- Root · 15 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 14 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 13 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 12 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 11 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 10 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 9 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- 8 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- 7 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- 6 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 5 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 4 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- 3 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- 2 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- 1 generation backK173960 DePuy Corail AMT Hip ProsthesisDepuy France S.A.S. · 2018
- This deviceK190344 DePuy Corail AMT Hip ProsthesisDepuy (Ireland) · 2019
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K211657EMPHASYS Femoral StemsDepuy Ireland UC · 2021 · cites it directly7descendants
- K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC · 2024 · 2 generations on5descendants
- K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC · 2025 · 3 generations on1descendant
- K243977EMPHASYS Acetabular SystemDepuy Ireland UC · 2025 · 3 generations on1descendant
- K223745Novae® Dual Mobility System, Hype® Hip SystemSerf · 2023 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −14 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −13 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −12 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −11 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −10 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −9 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| −8 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| −7 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| −6 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| −5 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| −4 | K111193 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2011 | — |
| −3 | K113242 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2012 | — |
| −2 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| −1 | K173960 | DePuy Corail AMT Hip Prosthesis | Depuy France S.A.S. | 2018 | — |
| 0 (this device) | K190344 | DePuy Corail AMT Hip Prosthesis | Depuy (Ireland) | 2019 | — |
| +1 | K211657 | EMPHASYS Femoral Stems | Depuy Ireland UC | 2021 | — |
| +2 | K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip… | Depuy Ireland UC | 2024 | — |
| +3 | K251292 | RECLAIM Monobloc Revision Femoral Stem | Depuy Ireland UC | 2025 | — |
| +3 | K243977 | EMPHASYS Acetabular System | Depuy Ireland UC | 2025 | — |
| +1 | K223745 | Novae® Dual Mobility System, Hype® Hip System | Serf | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1987 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 19 | 0 |
| 1995 | 12 | 0 |
| 1996 | 12 | 0 |
| 1997 | 7 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 18 | 0 |
| 2001 | 9 | 0 |
| 2002 | 10 | 0 |
| 2003 | 7 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 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 |
|---|---|---|---|
| * | K173960 | DePuy Corail AMT Hip ProsthesisSummary page 4…21 CFR 888.3353, 888.3360, 888.3390 Product Code(s) LZO, MEH, KWL, KWY Legally marketed device(s) to DePuy Corail AMT Hip Prosthesis (K173960, cleared September 21, 2018) which equivalence is claimed DePuy Corail AMT Hip Prosthesis (K123991, cleared September 16, 2013… | 2018 |
| * | K123991 | Depuy Corail Amt Hip ProsthesisSummary page 4…Y Legally marketed device(s) to DePuy Corail AMT Hip Prosthesis (K173960, cleared September 21, 2018) which equivalence is claimed DePuy Corail AMT Hip Prosthesis (K123991, cleared September 16, 2013) Reason for 510(k) submission Line extension – The subject devices represent hip stems with additi… | 2013 |
What descends from it? (11)
See all 113 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)
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 25 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
- 43 of the 174 ancestors have a recall of any class.
- Of its descendants, K211657 (Depuy Ireland UC, 2021) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K173960.
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. 2019, 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?
Total hip replacement or hip arthroplasty is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemi-arthroplasty, surface replacement…
Read the full statement (189 words)
Total hip replacement or hip arthroplasty is indicated in the following conditions:
1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions:
1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
3. Avascular necrosis of the femoral head.
4. Non-union of femoral neck fractures.
5. Certain high subcapital and femoral neck fractures in the elderly.
6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemi-arthroplasty.
HA coated stems of the Corail Hip System are indicated for cementless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190344 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190344: DePuy Corail AMT Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190344
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