510(k) · Cleared
ClearedCORAIL Cemented Femoral Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Ireland UC · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Dec 19, 2023 as substantially equivalent to K123991 (Depuy France S.A.S., 2013) and 1 other predicate after a 207-day review. Its family tree reaches back 14 generations to 1994.
- Decided
- Dec 19, 2023
- Review
- 207 days
- Class
- Class II
- Product code
- KWY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K941847 (1994). 188 ancestors in all, the oldest K802627 (1980). No later device cites it as a predicate yet.
- Root · 14 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 10 generations between
- 3 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- 2 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- 1 generation backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- This deviceK231526 CORAIL Cemented Femoral StemDepuy Ireland UC · 2023
Show all 14 generations
- Root · 14 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 13 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 12 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 11 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 10 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 9 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 8 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- 7 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- 6 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- 5 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 4 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 3 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- 2 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- 1 generation backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- This deviceK231526 CORAIL Cemented Femoral StemDepuy Ireland UC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −13 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −12 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −11 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −10 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −9 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −8 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| −7 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| −6 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| −5 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| −4 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| −3 | K111193 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2011 | — |
| −2 | K113242 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2012 | — |
| −1 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| 0 (this device) | K231526 | CORAIL Cemented Femoral Stem | Depuy Ireland UC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 20 | 0 |
| 1995 | 15 | 0 |
| 1996 | 13 | 0 |
| 1997 | 8 | 0 |
| 1998 | 9 | 0 |
| 1999 | 5 | 0 |
| 2000 | 18 | 0 |
| 2001 | 9 | 0 |
| 2002 | 10 | 0 |
| 2003 | 7 | 0 |
| 2004 | 8 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2022 | 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 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? (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 |
|---|---|---|---|
| * | K123991 | Depuy Corail Amt Hip ProsthesisSummary page 5…21 CFR 888.3390, 888.3360, 888.3353 Product Code(s) KWY, KWL, LZO Legally marketed device(s) to Primary predicate - DePuy CORAIL AMT Hip Prosthesis K123991, cleared which equivalence is claimed September 16, 2013 Secondary predicate – C-STEM AMT LE P… | 2013 |
| * | K220216 | C-Stem AMT LE ProsthesisSummary page 5…AIL AMT Hip Prosthesis K123991, cleared which equivalence is claimed September 16, 2013 Secondary predicate – C-STEM AMT LE Prosthesis K220216, cleared July 22, 2022 Reason for 510(k) submission The purpose of this 510K submission is to… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 47 of the 187 ancestors have a recall of any class.
- 10 other devices also cite its predicate K123991.
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. 2023, 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?
The use of CORAIL Cemented Femoral Stems is indicated in Total and Hemi hip replacements. 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…
Read the full statement (182 words)
The use of CORAIL Cemented Femoral Stems is indicated in Total and Hemi hip replacements.
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.
Partial hip 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. Avascular necrosis of the femoral head.
3. Non-union of femoral neck fractures.
4. Certain high subcapital and femoral neck fractures in the elderly.
5. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
6. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemiarthroplasty.
The DePuy CORAIL Cemented Femoral Stems are indicated only for use with bone cement.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K231526 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231526: CORAIL Cemented 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/K231526
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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