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Protrusion Cages

by Depuy, Inc. 510(k)

Active United States

510(k) K962007

Overview

The Protrusion Cages are a type of surgical mesh device classified as an Acetabular Hip Prosthesis (Product Code JDJ). These cages are designed to reinforce a deficient or weakened medial acetabular wall, preventing protrusion of an acetabular cup prosthesis into the abdominal cavity during hip revision procedures.

Intended for use in acetabular revision surgeries, these cages are supplied sterile and are reusable as part of the surgical implant system. They are regulated under FDA 510(k) clearance (K962007) and fall under Class II – Special Controls. The device is manufactured by Depuy, Inc., with regulatory compliance under the classification Mesh, Surgical, Acetabular, Hip, Prosthesis.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK962007 Date1 Aug 1996ClearedStatusActive

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 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JDJ
Device Class
Class II
Regulation
21 CFR Part 878.3300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Other devices from Depuy, Inc.

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Questions

  • Are the Protrusion Cages intended for primary hip replacements or specifically for revision surgeries?

    The Protrusion Cages are designed specifically for acetabular revision surgeries. They are intended to reinforce a deficient or weakened medial acetabular wall, preventing protrusion of an acetabular cup prosthesis into the abdominal cavity during these procedures. This makes them a targeted solution for complex revisions rather than primary hip replacements.

  • How are the Protrusion Cages supplied, and are they reusable or single-use?

    The Protrusion Cages are supplied sterile and are part of a reusable surgical implant system. This means they are intended to be used in multiple procedures after proper sterilization between uses, rather than being discarded after a single application.

  • What regulatory pathway was followed for the FDA clearance of the Protrusion Cages, and which medical specialty oversees their use?

    The Protrusion Cages received FDA clearance through a 510(k) submission (K962007) under the Traditional clearance type, determined to be Substantially Equivalent to a predicate device. The device falls under Class II – Special Controls and is regulated under the Mesh, Surgical, Acetabular, Hip, Prosthesis category. The General, Plastic Surgery advisory committee oversees submissions related to this device.

  • Are there multiple sizes or models of Protrusion Cages available, and how would a clinician determine the correct fit for a patient?

    While the provided data does not specify exact sizes or models, the Protrusion Cages are listed under OpenFDA with multiple FEI numbers, indicating there may be variations in design or dimensions to accommodate different anatomical needs. Clinicians would typically rely on preoperative imaging and surgical planning to select the appropriate cage size, ensuring proper reinforcement of the medial acetabular wall during revision procedures.