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Esop Co-Cr Femoral Heads

by Pro-Active Healthcare

510(k) K023375

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Special NumberK023375 Date25 Oct 2002ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Modification to Esop Co-Cr Femoral Heads
510(k) Number
FDA Product Code
LPH
Device Class
Class II
Regulation
21 CFR Part 888.3358
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Esop Co-Cr Femoral Head is a metallic prosthetic component designed for hip arthroplasty. It attaches to femoral stems via machined 12/14 or 10/12 tapers and is indicated for use in cases of degenerative and inflammatory arthritis, trauma, non-acute femoral neck fractures, revision of failed hip arthroplasties, and idiopathic avascular necrosis.

This device is available in multiple diameters and various insertion depths, including short, medium, long, and extra-long collars, to facilitate adjustment of neck length. It is intended for use by orthopedic surgeons in clinical settings where sufficient sound bone is present to seat the prosthesis. The device is authorized under FDA 510(k) clearance K023375.

Questions

AI-generated answers, 22 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 clinical conditions is the Esop Co-Cr Femoral Head indicated for?

    This device is indicated for use in hip arthroplasty procedures involving degenerative and inflammatory arthritis, trauma, non-acute femoral neck fractures, idiopathic avascular necrosis, and the revision of previously failed hip arthroplasties.

  • How does the device accommodate different patient neck lengths?

    The femoral heads are available in multiple diameters and various insertion depths, including short, medium, long, and extra-long collars, which allow orthopedic surgeons to adjust the neck length during the surgical procedure.

  • What are the technical requirements for attaching the femoral head?

    The device is designed to attach to femoral stems using either 12/14 or 10/12 machined tapers. It is intended for use in clinical settings where there is sufficient sound bone present to properly seat the prosthesis.

  • What is the regulatory status of this device?

    The Esop Co-Cr Femoral Head is authorized under FDA 510(k) clearance K023375, which determined the device to be substantially equivalent to existing predicate devices.