LogoFDA 510(k) Search
K Number
K032095
Device Name
INTERPORE CROSS CEMENT RESTRICTOR
Manufacturer
INTERPORE CROSS INTL.
Date Cleared
2003-08-08

(31 days)

Product Code
JDK
Regulation Number
878.3300
Type
Special
Panel
Orthopedic
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Interpore Cross CEMENT RESTRICTOR is intended for use as a cement restrictor in the femur, tibia and/or humerus. WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.

Device Description

The Interpore Cross CEMENT RESTRICTOR is a resorbable implant manufactured from a polymer-ceramic composite. The Interpore Cross CEMENT RESTRICTOR is designed to wedge into the medullary canal during joint arthroplasty to prevent flow of cement into the canal and allow for pressurized filling of the implantation site. It is provided in various shapes and sizes as needed for particular surgical procedures.

AI/ML Overview

This document is a 510(k) summary for the Interpore Cross Cement Restrictor. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) process is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It typically focuses on demonstrating substantial equivalence rather than presenting performance data against set acceptance criteria for a novel device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided document. The document primarily focuses on:

  • Device Description: The Interpore Cross CEMENT RESTRICTOR is a resorbable implant made from a polymer-ceramic composite, designed to wedge into the medullary canal to prevent cement flow and allow for pressurized filling during joint arthroplasty.
  • Indications-For-Use: As a cement restrictor in the femur, tibia, and/or humerus.
  • Predicate Device: Interpore Cross Cement Restrictor (suggesting it's an update or new version of an existing product).
  • Substantial Equivalence: Claimed to be substantially equivalent to the cited predicate devices based on indications for use, design features, principles of operation, and materials.
  • FDA Communication: The FDA letter confirms the substantial equivalence determination but adds a WARNING: "THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED." This indicates a specific limitation on the device's use due to a lack of established safety and effectiveness in that particular application.

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.