Skip to content

Icona Hip Stem 7260104

by Corin Ltd

Icona Hip Stem 7260104 is a Class II device made by Corin Ltd, cleared under FDA 510(k) K241472 on 3 Oct 2024 and listed in FDA GUDID since 7 Apr 2025 (UDI-DI 05056139247095), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K241472

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05056139247095 UDI-DI Date7 Apr 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK241472 Date3 Oct 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K241472 decided 3 Oct 2024 Active
  • FDA GUDID UDI-DI 05056139247095 listed 7 Apr 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K241472
  2. Listed FDA GUDID 05056139247095

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Icona Hip Stem
Generic name
Coated hip femur prosthesis, modular
Model / reference
7260104
Primary DI / UDI-DI
05056139247095
510(k) Number
FDA product code
MEH, KWL, KWY, LZO
GMDN term
Coated hip femur prosthesis, modular
Device class
Class II
Regulation number
888.3353, 888.3360, 888.3390
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization
MRI safety
MR Conditional

Related devices

Category: Coated hip femur prosthesis, modular

Cleared under the same submission (K241472)

and 8 more cleared under K241472

Similar devices

Other devices filed under FDA product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate).

Other devices from Corin Ltd

See all devices from Corin Ltd →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)