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Solution System Cup

by Depuy, Inc. 510(k)

Active United States

510(k) K915216

Overview

The Solution System Cup is a Hip Prosthesis, Semi-Constrained, Metal/Polymer, Cemented (Product Code: JDI), designed for orthopedic hip replacement surgery. It features a metal femoral component paired with a polymer acetabular cup, secured with bone cement to ensure stable fixation within the pelvic bone.

This device is intended for use in orthopedic settings, supplied sterile for single-patient use. It is classified as Class II under FDA regulations and received FDA 510(k) clearance (K915216) in 1992. Storage and handling must comply with sterile medical device protocols to maintain integrity before implantation.

AI-generated from registry data, 19 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 NumberK915216 Date11 Feb 1992ClearedStatusActive

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
JDI
Device Class
Class II
Regulation
21 CFR Part 888.3350
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What types of hip surgeries is the Solution System Cup designed for, and how is it secured in place?

    The Solution System Cup is specifically designed for orthopedic hip replacement surgeries where a semi-constrained hip prosthesis is required. It consists of a metal femoral component paired with a polymer acetabular cup, both of which are secured to the patient’s bone using bone cement. This cemented fixation ensures stable integration within the pelvic bone, providing long-term stability for the patient.

  • Is the Solution System Cup intended for reuse, or is it meant for single-patient use only?

    The Solution System Cup is supplied sterile and explicitly intended for single-patient use only. This ensures patient safety and compliance with sterile medical device protocols, preventing cross-contamination or reuse risks.

  • What storage and handling precautions should be taken with the Solution System Cup before implantation?

    The Solution System Cup must be stored and handled according to sterile medical device protocols to preserve its integrity before use. This includes maintaining sterile packaging, avoiding contamination, and adhering to manufacturer guidelines to ensure the device remains uncontaminated until implantation.

  • What materials are used in the Solution System Cup, and how does this affect its design?

    The Solution System Cup combines a metal femoral component with a polymer acetabular cup, creating a semi-constrained design. This material pairing balances durability, stability, and biocompatibility, allowing for secure fixation via bone cement while reducing wear and friction in the hip joint.