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CORAIL Cemented Femoral Stem

by DePuy Ireland UC

510(k) K231526

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K231526↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK231526 Date19 Dec 2023ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
KWY
Device Class
Class II
Regulation
21 CFR Part 888.3390
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The CORAIL Cemented Femoral Stem is a Hip Joint Femoral Prosthesis designed for use in total hip arthroplasty. It is a cemented, modular femoral component intended to replace the femoral head and neck in patients requiring hip joint reconstruction, providing stability and load-bearing function within the hip joint.

This device is supplied as a single-use, sterile implant and is intended for use in orthopedic surgical settings. It is regulated under 21 CFR 888.3390 for Hip Joint Femoral (Hemi-Hip) applications, with FDA 510(k) clearance (K231526) and MDR compliance. The modular design allows for customization to fit individual patient anatomy, and it is distributed in sterile packaging for surgical use.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of patients is the CORAIL Cemented Femoral Stem intended for in a clinical setting?

    The CORAIL Cemented Femoral Stem is designed for patients undergoing total hip arthroplasty who require replacement of the femoral head and neck due to conditions like osteoarthritis, fractures, or other degenerative joint diseases. Its modular design allows for customization to fit individual patient anatomy, ensuring a tailored fit for stability and load-bearing function during hip reconstruction.

  • Is the CORAIL Cemented Femoral Stem reusable or single-use, and how is it packaged for surgical use?

    The CORAIL Cemented Femoral Stem is supplied as a single-use device and comes in sterile packaging specifically prepared for surgical environments. This ensures sterility and compliance with orthopedic surgical protocols, preventing contamination and ensuring patient safety.

  • How is the CORAIL Cemented Femoral Stem regulated, and what does its FDA clearance status mean for buyers?

    The CORAIL Cemented Femoral Stem holds FDA 510(k) clearance (K231526) under 21 CFR 888.3390, confirming it is deemed substantially equivalent to a legally marketed predicate device. This means it meets regulatory standards for safety and effectiveness as determined by the FDA’s review process, providing assurance to buyers of its compliance with U.S. medical device regulations.

  • What does the modular design of the CORAIL Cemented Femoral Stem allow surgeons to achieve during surgery?

    The modular design of the CORAIL Cemented Femoral Stem enables surgeons to customize the implant to match the specific anatomy of each patient. This flexibility helps optimize fit, stability, and load distribution within the hip joint, improving the likelihood of a successful reconstruction tailored to individual needs.

  • How should the CORAIL Cemented Femoral Stem be stored before use, given its sterile packaging?

    Since the CORAIL Cemented Femoral Stem is supplied in sterile packaging, it should be stored in a clean, dry environment protected from moisture, dust, and extreme temperatures as per standard orthopedic implant handling guidelines. The packaging integrity must remain uncompromised until immediate preoperative use to maintain sterility.