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K Number
K981855
Device Name
PRINCE MEDICAL CEMENT PLUG
Manufacturer
PRINCE MEDICAL, INC.
Date Cleared
1998-08-10

(76 days)

Product Code
JDI
Regulation Number
888.3350
Type
Traditional
Panel
Orthopedic
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Prince Medical Cement Plug is indicated for use with cemented total hip or endoprosthetic femoral components to :

    1. Prevent the bone cement from distal migration during its insertion.
    1. Increase the pressure of the cement during cement and femoral component insertion to facilitate bone penetration and distribution of the cement.
Device Description

The Prince Medical Cement Plug consists of various sizes and is made from Medical Grade Ultra High Molecular Weight Polyethylene (UHMWPE). The component is produced in two outside diameters and is introduced into the medullary canal using a stainless steel inserting tool. Under this premarket notification, the device is available in 18.5 and 25.0mm outside diameter.

AI/ML Overview

The provided text is a 510(k) premarket notification summary for the Prince Medical Cement Plug. It does NOT contain information about specific acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on describing the device, its materials, biocompatibility, sterilization, utilization, indications for use, and regulatory clearance based on substantial equivalence to previously marketed devices.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets them from the provided text. The document is a regulatory approval notice, not a clinical study report.

§ 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.