510(k) · Cleared
ClearedDepuy Corail Amt Dysplasia 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 Sep 11, 2007 as substantially equivalent to K042992 (DePuy Orthopaedics, Inc., 2005) and 1 other predicate after a 196-day review. Its family tree reaches back 6 generations to 1994. 49 later devices descend from it.
- Decided
- Sep 11, 2007
- Review
- 196 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K935452 (1994). 16 ancestors in all, the oldest K851422 (1985). 49 later devices descend from it, 5 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 deviceK070554 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 · 2 generations on · 38 of its ownK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 27 of its ownK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
- Descendant · 3 generations on · 26 of its ownK160907 DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland) · 2016
- Descendant · 3 generations on · 20 of its ownK193398 Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · cites it directly48descendants
- K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · 2 generations on38descendants
- K170339Summit Hip SystemDePuy Orthopaedics, Inc. · 2018 · 2 generations on27descendants
- K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland) · 2016 · 3 generations on26descendants
- K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020 · 3 generations on20descendants
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) | 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 |
| +2 | K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 | 1 |
| +2 | K170339 | Summit Hip System | DePuy Orthopaedics, Inc. | 2018 | — |
| +3 | K160907 | DePuy Actis DuoFix Hip Prosthesis | Depuy (Ireland) | 2016 | — |
| +3 | K193398 | Summit DuoFix HA Coating | DePuy Orthopaedics, Inc. | 2020 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 6 | 0 |
| 2025 | 10 | 0 |
| 2026 | 7 | 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 |
|---|---|---|---|
| * | K042992 | Corail Amt Hip ProsthesisSummary page 1…mented or nonporous uncemented prosthesis; Class 11 DEVICE PRODUCT CODES: LZO, MEH, KWA SUBSTANTIALLY EQUIVALENT DEVICES: DePuy Corail AMT Hip Prosthesis (K042992) DePuy S-Rom Femoral Hip Stem, Size 12 x 06 x 115 (K96 1939) DEV… | 2005 |
| * | K961939 | S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Summary page 1…: DePuy Corail AMT Hip Prosthesis (K042992) DePuy S-Rom Femoral Hip Stem, Size 12 x 06 x 115 (K96 1939) DEVICE DESCRIPTION: The Corail AMT Hip Prosthesis is a collarless, hydroxyapatite coated titanium alloy femoral stem. The Corai… | 1996 |
What descends from it? (49)
See all 495 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 13 years and passes through 3 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, K123991 (Depuy France S.A.S., 2013) has gone furthest, with 48 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. 2007, 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 Corail AMT Hip Prosthesis is intended for use in total hip arthroplasty and is intended for press fit (uncemented) use. Total hip arthroplasty is intended to provide increased patient 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 components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or…
Read the full statement (136 words)
The Corail AMT Hip Prosthesis is intended for use in total hip arthroplasty and is intended for press fit (uncemented) use. Total hip arthroplasty is intended to provide increased patient 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 components. Total hip replacement 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, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
The non-porous Corail AMT Hip Stem is indicated for cementless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070554 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070554: Depuy Corail Amt Dysplasia Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070554
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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