# K250375: Allure Hip Stem and Intramedullary Plugs

- Pathway: 510(k) (Traditional)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: Nov 5, 2025 after 268 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K941847 (1994). 289 ancestors in all.
No later device cites it as a predicate yet.
0 of 289 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150862: DePuy Actis Duofox Hip Prosthesis, DePuy Orthopaedics, Inc. (2015) Summary page 5.
- K160907: DePuy Actis DuoFix Hip Prosthesis, Depuy (Ireland) (2016) Summary page 5.
- K210581: Actis DuoFix Hip Prosthesis- Collarless, Depuy Ireland UC (2021) Summary page 5.
- K211703: Insignia Hip Stem, Stryker Orthopaedics (2021) Summary page 5.
- K220731: Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem, Stryker (2022) Summary page 5.
- K152530: UCP Stem, United Orthopedic Corporation (2016) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K250375
Methodology: https://510kreport.com/methodology