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K Number
K001984
Device Name
PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT
Manufacturer
STELKAST COMPANY
Date Cleared
2000-09-27

(90 days)

Product Code
JDG
Regulation Number
888.3360
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
    1. Joint impairment from arthritis (rheumatoid, osteo and post traumatic).
    1. Revision of failed femoral head replacements.
    1. When alternative reconstructive techniques are not viable.
    1. . When arthrodesis is contraindicated.
    1. Avascular necrosis or fracture of the femoral head.
    1. Congenital defects that will allow adequate function of the system.
Device Description

Progeny Forged CoCr Cemented Femoral Component

AI/ML Overview

I am sorry, but the provided text is a decision letter from the FDA regarding a 510(k) premarket notification for a medical device (Progeny Forged CoCr Cemented Femoral Component).

This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. It primarily indicates that the device has been found substantially equivalent to a legally marketed predicate device and can proceed to market.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.