510(k) · Cleared
Recalled · Class II · 2018Depuy Corail Amt Hip Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy France S.A.S. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Sep 16, 2013 as substantially equivalent to K070554 (DePuy Orthopaedics, Inc., 2007) and 4 other predicates after a 264-day review. Its family tree reaches back 13 generations to 1994. 48 later devices descend from it. It has been recalled once.
- Decided
- Sep 16, 2013
- Review
- 264 days
- Class
- Class II
- Product code
- KWY
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 13 generations to K941847 (1994). 173 ancestors in all, the oldest K810258 (1981). 48 later devices descend from it, 11 citing it directly.
- Root · 13 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 9 generations between
- 3 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 2 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- 1 generation backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- This deviceK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013
- Descendant · cites it directly · 38 of its ownK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- Descendant · cites it directly · 27 of its ownK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
- Descendant · 2 generations on · 26 of its ownK160907 DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland) · 2016
- Descendant · 2 generations on · 20 of its ownK193398 Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020
- Descendant · 2 generations on · 15 of its ownK202472 ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020
Show all 13 generations
- Root · 13 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 12 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 11 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 10 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 9 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 8 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 7 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- 6 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- 5 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- 4 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 3 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 2 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- 1 generation backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- This deviceK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · cites it directly38descendants
- K170339Summit Hip SystemDePuy Orthopaedics, Inc. · 2018 · cites it directly27descendants
- K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland) · 2016 · 2 generations on26descendants
- K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020 · 2 generations on20descendants
- K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −12 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −11 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −10 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −9 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −8 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −7 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| −6 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| −5 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| −4 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| −3 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| −2 | K111193 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2011 | — |
| −1 | K113242 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2012 | — |
| 0 (this device) | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | — |
| +1 | K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 | 1 |
| +1 | K170339 | Summit Hip System | DePuy Orthopaedics, Inc. | 2018 | — |
| +2 | K160907 | DePuy Actis DuoFix Hip Prosthesis | Depuy (Ireland) | 2016 | — |
| +2 | K193398 | Summit DuoFix HA Coating | DePuy Orthopaedics, Inc. | 2020 | — |
| +2 | K202472 | ACTIS Duofix Hip Prosthesis | DePuy Orthopaedics, Inc. | 2020 | — |
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 |
|---|---|---|
| 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWY? 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 KWY device
- #1 K253357 b-ONE® Bipolar Headscore 11.2 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K070554 | Depuy Corail Amt Dysplasia Hip ProsthesisSummary page 1…Devices Regulation 21 CFR 888.3390: 888.3353; 8888.3360 Product Code(s) KWY, LZO. KWL Legally marketed Corail AMTT' Hip Prosthesis (K070554: K042992) device(s) to which MletaFix Femoral Stem for Hemni-Arthroplasty (K 120362) equivalence is Apex ARC… | 2007 |
| * | K042992 | Corail Amt Hip ProsthesisSummary page 1…Regulation 21 CFR 888.3390: 888.3353; 8888.3360 Product Code(s) KWY, LZO. KWL Legally marketed Corail AMTT' Hip Prosthesis (K070554: K042992) device(s) to which MletaFix Femoral Stem for Hemni-Arthroplasty (K 120362) equivalence is Apex ARC I-lip Ste… | 2005 |
| * | K120362 | Metafix Femoral Stem for Hemi-ArthroplastySummary page 1…KWY, LZO. KWL Legally marketed Corail AMTT' Hip Prosthesis (K070554: K042992) device(s) to which MletaFix Femoral Stem for Hemni-Arthroplasty (K 120362) equivalence is Apex ARC I-lip Stein (KI 13242; KI 11193) claimedI Reason for 510(k) Expand currently cleare… | 2012 |
| * | K113242 | Apex Arc Hip StemSummary page 2…Characteristic DePuy Orthopaedics Corail icia Fix Femoral Stem Apex ARC Hip Stem AMTr" Hip Prosthesis for Hemi-Artbroplasty (K<113242 and 11193) (subject device, predicate (KC120362) devices: K<070554; K<042992) __… | 2012 |
| * | K111193 | Apex Arc Hip Stem | 2011 |
What descends from it? (48)
See all 4811 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150862 | DePuy Actis Duofox Hip Prosthesis | 2015 | 38 |
| K170339 | Summit Hip System | 2018 | 27 |
| K173960 | DePuy Corail AMT Hip Prosthesis | 2018 | 14 |
| K190344 | DePuy Corail AMT Hip Prosthesis | 2019 | 11 |
| K192946 | DePuy Corail AMT Hip Prosthesis | 2019 | 10 |
| K211657 | EMPHASYS Femoral Stems | 2021 | 7 |
| K203167 | DePuy Corail AMT Hip Prosthesis | 2020 | 2 |
| K171249 | Entrada™ hip stem | 2017 | 2 |
| K223745 | Novae® Dual Mobility System, Hype® Hip System | 2023 | 1 |
| K161840 | LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip… | 2017 | 1 |
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 19 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 42 of the 172 ancestors have a recall of any class.
- Of its descendants, K150862 (DePuy Orthopaedics, Inc., 2015) has gone furthest, with 38 descendants of its own.
- 4 other devices also cite its predicate K070554.
How does its category compare?
All KWY devicesKWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · KWY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWY
126in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWY
180in 2025
MAUDE reports naming product code KWY, 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 | 0 | — | 25 | 370 |
| 2008 | 3 | 123 | 0 | 900 |
| 2009 | 1 | — | 24 | 961 |
| 2010 | 4 | 187 | 1 | 688 |
| 2011 | 1 | — | 0 | 758 |
| 2012 | 1 | — | 1 | 978 |
| 2013 | 2 | — | 2 | 1,148 |
| 2014 | 1 | — | 0 | 1,055 |
| 2015 | 1 | — | 0 | 1,213 |
| 2016 | 1 | — | 3 | 877 |
| 2017 | 1 | — | 2 | 826 |
| 2018 | 3 | 219 | 1 | 1,380 |
| 2019 | 5 | 126 | 1 | 1,530 |
| 2020 | 1 | — | 0 | 1,259 |
| 2021 | 0 | — | 0 | 276 |
| 2022 | 2 | — | 0 | 208 |
| 2023 | 2 | — | 0 | 178 |
| 2024 | 0 | — | 1 | 209 |
| 2025 | 1 | — | 2 | 180 |
| 2026 | 1 | — | 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 510(k) statement.
https://510kreport.com/device/K123991 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123991: 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/K123991
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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