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B2C, Espace Revision Cup System

by Turnkey Intergration USA, Inc. 510(k)

Active United States

510(k) K990523

Overview

The B2C, Espace Revision Cup System is a pelvic component for total hip arthroplasty, designed to address large acetabular defects in the floor and superior aspects of the acetabular cavity. It is intended to be used as the acetabular component in hip replacement procedures.

The device is implanted by a surgeon in an operating room setting, with fixation achieved via press-fit with bone screws or by cementing into the cavity. It is supplied as a non-sterile, reusable surgical instrument system and has received FDA 510(k) clearance under K990523 with product code LPH.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK990523 Date30 Apr 1999ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

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Questions

  • What is the B2C Espace Revision Cup System used for?

    The B2C Espace Revision Cup System is a pelvic component for total hip arthroplasty, designed to address large acetabular defects in the floor and superior aspects of the acetabular cavity. It is intended to be used as the acetabular component in hip replacement procedures, providing structural support where bone loss compromises standard cup fixation.

  • How is the B2C Espace Revision Cup System implanted and fixed?

    The device is implanted by a surgeon in an operating room setting. Fixation is achieved either through press-fit with bone screws or by cementing into the acetabular cavity, depending on the surgeon’s assessment of bone quality and defect morphology. This dual fixation option allows adaptability to varying intraoperative conditions.

  • Is the B2C Espace Revision Cup System sterile or non-sterile, and is it reusable?

    The B2C Espace Revision Cup System is supplied as a non-sterile, reusable surgical instrument system. It must be cleaned and sterilized by the healthcare facility prior to each use, following validated reprocessing protocols to ensure patient safety and device integrity across multiple uses.

  • What regulatory pathway was used for the B2C Espace Revision Cup System?

    The B2C Espace Revision Cup System received FDA 510(k) clearance under submission number K990523, with a decision date of April 30, 1999. It was found substantially equivalent to a predicate device and is classified under product code LPH, which pertains to hip joint acetabular components.