510(k) · Cleared
ClearedAllure Hip Stem and Intramedullary Plugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Waldemar Link GmbH & Co. KG · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Nov 5, 2025 as substantially equivalent to K150862 (DePuy Orthopaedics, Inc., 2015) and 5 other predicates after a 268-day review. Its family tree reaches back 20 generations to 1994.
- Decided
- Nov 5, 2025
- Review
- 268 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 20 generations to K941847 (1994). 289 ancestors in all, the oldest K802627 (1980). No later device cites it as a predicate yet.
- Root · 20 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 16 generations between
- 3 generations backK202472 ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020
- 2 generations backK211703 Insignia Hip StemStryker Orthopaedics · 2021
- 1 generation backK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022
- This deviceK250375 Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG · 2025
Show all 20 generations
- Root · 20 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 19 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 18 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 17 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 16 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 15 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 14 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- 13 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- 12 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- 11 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 10 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 9 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- 8 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- 7 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- 6 generations backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- 5 generations backK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
- 4 generations backK193398 Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020
- 3 generations backK202472 ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020
- 2 generations backK211703 Insignia Hip StemStryker Orthopaedics · 2021
- 1 generation backK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022
- This deviceK250375 Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −19 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −18 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −17 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −16 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −15 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −14 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| −13 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| −12 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| −11 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| −10 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| −9 | K111193 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2011 | — |
| −8 | K113242 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2012 | — |
| −7 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| −6 | K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 | 1 |
| −5 | K170339 | Summit Hip System | DePuy Orthopaedics, Inc. | 2018 | — |
| −4 | K193398 | Summit DuoFix HA Coating | DePuy Orthopaedics, Inc. | 2020 | — |
| −3 | K202472 | ACTIS Duofix Hip Prosthesis | DePuy Orthopaedics, Inc. | 2020 | — |
| −2 | K211703 | Insignia Hip Stem | Stryker Orthopaedics | 2021 | — |
| −1 | K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | Stryker | 2022 | — |
| 0 (this device) | K250375 | Allure Hip Stem and Intramedullary Plugs | Waldemar Link GmbH & Co. KG | 2025 | — |
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 | 2 | 0 |
| 1990 | 4 | 0 |
| 1991 | 7 | 0 |
| 1992 | 7 | 0 |
| 1993 | 4 | 0 |
| 1994 | 24 | 0 |
| 1995 | 18 | 0 |
| 1996 | 17 | 0 |
| 1997 | 13 | 0 |
| 1998 | 15 | 0 |
| 1999 | 7 | 0 |
| 2000 | 24 | 0 |
| 2001 | 14 | 0 |
| 2002 | 21 | 0 |
| 2003 | 13 | 0 |
| 2004 | 11 | 0 |
| 2005 | 12 | 0 |
| 2006 | 7 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 8 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2021 | 2 | 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 MEH? 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 MEH device
- #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K150862 | DePuy Actis Duofox Hip ProsthesisSummary page 5…Devices: Subject Device Predicate Devices 510(k) Number Components Allure Hip Stem 1. DePuy Orthopaedics, Actis DuoFix Hip K150862, K160907, Prosthesis [Primary Predicate] K210581 2. Stryker Orthopaedic… | 2015 |
| * | K160907 | DePuy Actis DuoFix Hip ProsthesisSummary page 5…Subject Device Predicate Devices 510(k) Number Components Allure Hip Stem 1. DePuy Orthopaedics, Actis DuoFix Hip K150862, K160907, Prosthesis [Primary Predicate] K210581 2. Stryker Orthopaedics, Insign… | 2016 |
| * | K210581 | Actis DuoFix Hip Prosthesis- CollarlessSummary page 5…mber Components Allure Hip Stem 1. DePuy Orthopaedics, Actis DuoFix Hip K150862, K160907, Prosthesis [Primary Predicate] K210581 2. Stryker Orthopaedics, Insignia Hip Stem K211703, K220731 [Additional Predicat… | 2021 |
| * | K211703 | Insignia Hip StemSummary page 5…K150862, K160907, Prosthesis [Primary Predicate] K210581 2. Stryker Orthopaedics, Insignia Hip Stem K211703, K220731 [Additional Predicate] Intramedullary Plugs 1. United Orthopedic Corp. Cement Restrictor K1525… | 2021 |
| * | K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemSummary page 5…150862, K160907, Prosthesis [Primary Predicate] K210581 2. Stryker Orthopaedics, Insignia Hip Stem K211703, K220731 [Additional Predicate] Intramedullary Plugs 1. United Orthopedic Corp. Cement Restrictor K152530… | 2022 |
| * | K152530 | UCP StemSummary page 5…r Orthopaedics, Insignia Hip Stem K211703, K220731 [Additional Predicate] Intramedullary Plugs 1. United Orthopedic Corp. Cement Restrictor K152530 [Additional Predicate] Reason for New Device System Components Submission:… | 2016 |
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 31 years and passes through 10 companies; a new generation was cleared every 1.6 years on median.
- 81 of the 288 ancestors have a recall of any class.
- 13 other devices also cite its predicate K150862.
How does its category compare?
All MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 2025
MAUDE reports naming product code MEH, 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 | 2 | — | 3 | 25 |
| 2008 | 6 | 79 | 80 | 261 |
| 2009 | 6 | 65 | 51 | 539 |
| 2010 | 5 | 226 | 16 | 462 |
| 2011 | 5 | 95 | 4 | 419 |
| 2012 | 6 | 131 | 3 | 1,606 |
| 2013 | 1 | — | 0 | 1,295 |
| 2014 | 0 | — | 1 | 1,196 |
| 2015 | 2 | — | 1 | 490 |
| 2016 | 6 | 163 | 4 | 347 |
| 2017 | 3 | 209 | 1 | 383 |
| 2018 | 2 | — | 3 | 337 |
| 2019 | 1 | — | 0 | 335 |
| 2020 | 3 | 131 | 1 | 338 |
| 2021 | 3 | 83 | 0 | 372 |
| 2022 | 3 | 150 | 0 | 316 |
| 2023 | 2 | — | 0 | 334 |
| 2024 | 6 | 91 | 0 | 354 |
| 2025 | 5 | 87 | 1 | 470 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Allure Hip Stems are intended to be used in total and partial (hemi-) hip arthroplasty to treat mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures. The Allure Hip Stems are intended for uncemented use only.
Indications:
- Primary and secondary osteoarthritis
- Rheumatoid arthritis
- Correction of functional deformities
- Avascular necrosis
- Femoral neck fractures
- Revision surgeries
The Intramedullary Plugs are intended for use with cemented hip stem prostheses to prevent uncontrolled diffusion of bone cement within the medullary canal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250375 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250375: Allure Hip Stem and Intramedullary Plugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250375
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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