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K Number
K982670
Device Name
CONTEMPORARY ACETABULAR COMPONENT
Manufacturer
HOWMEDICA CORP.
Date Cleared
1998-10-02

(63 days)

Product Code
JDI
Regulation Number
888.3350
Type
Traditional
Panel
OR
Reference & Predicate Devices
K912426,K924115
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Contemporary Acetabular Component is intended to be used to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. This component is designed to be cemented into the acetabulum.

Device Description

The Contemporary Acetabular Component is a polyethylene cup that is intended to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. This cup is designed to be cemented into the acetabulum. The Contemporary Acetabular Component is available in outer diameters of 38 to 80mm in two millimeter increments. These cups are manufactured from Ultra High Molecular Weight Polyethylene which conforms to ASTM F-648.

AI/ML Overview

The provided text is a 510(k) summary for the Contemporary Acetabular Component, a medical device for hip replacement. It outlines the device description, intended use, and claims of substantial equivalence to previously marketed devices. However, it does not contain any information regarding acceptance criteria or a study proving the device meets said criteria, as is common for many 510(k) submissions that rely on predicate device equivalence.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on demonstrating equivalence, not on specific performance acceptance criteria or a study proving those criteria were met for this particular device.

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.