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K Number
K972961
Device Name
STELKAST BIPOLAR SYSTEM
Manufacturer
STELKAST COMPANY
Date Cleared
1997-11-04

(85 days)

Product Code
JDI,KWY
Regulation Number
888.3350
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
    1. Fractures of the proximal femur
    1. Non-unions of proximal femoral neck fractures.
  • Aseptic necrosis of the femoral head: 3.
    1. Osteo-rheumatoid and post-traumatic arthritis of the hip with minimal distortion of the acetabulum.
    1. Salvage of failed total hip arthroplasty.
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) notification for the "Skelkast Bipolar System" (K972961) does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

This document is a letter from the FDA stating that the device has been determined to be substantially equivalent to a legally marketed predicate device and can therefore be marketed. It lists the indications for use but does not detail any performance metrics, study design, or results that you have requested.

Therefore, I cannot provide the information requested in your prompt based on the input text.

§ 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.