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K Number
K032110
Device Name
PROCLASS PRESS FIT HIP STEM
Manufacturer
STELKAST COMPANY
Date Cleared
2003-09-22

(75 days)

Product Code
LWJ,LZO
Regulation Number
888.3360
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  1. The ProClass Press Fit Hip Stem is a single use, cementless device used for reconstruction of the articulating surface of the femur portion of the hip that is severely disabled and/or very painful resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or fracture of the femoral head provided there is sufficient sound bone to seat the prosthesis.
  2. The stem can be used for primary hip implant or for hip revision of a failed implant.
  3. The stem can be used for congenital defects that will allow adequate function of the system.
Device Description

ProClass Press Fit Hip Stem is a single use, cementless device.

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance tables, study designs, sample sizes (for test or training sets), data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

The document is an FDA 510(k) clearance letter for the "ProClass Press Fit Hip Stem." It primarily states that the device is substantially equivalent to legally marketed predicate devices and lists its intended "Indications For Use." It does not include data from a study that would demonstrate the device meets specific acceptance criteria.

§ 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.