CEMENTED FEMORAL HEAD RESURFING DEVICE

• K Number: K021799
• Device Name: CEMENTED FEMORAL HEAD RESURFING DEVICE
• Manufacturer: BIOMET ORTHOPEDICS, INC.
• Date Cleared: 2002-06-26 ( 26 days)
• Product Code: KXA
• Regulation Number: 888.3400
• Type: Special
• Panel: OR
• Reference & Predicate Devices: K983452

Intended Use

• Non-inflammatory degenerative joint disease, including osteoarthritis and a) avascular necrosis
• b) Rheumatoid arthritis

The device is a single use implant intended for use with bone cement

Device Description

The Cemented Femoral Head Resurfacing device is designed to replace the outer surface of the femoral head while preserving as much natural bone as possible. The device retains the diameter of the natural femoral head and articulates aqainst the natural acetabulum (hemi-hip).

The device is manufactured from cobalt alloy (Co-Cr-Mo) conforming to ASTM F-75. It has a highly polished outer surface and a grit blasted (roughened) inner surface identical to the predicate device. A central post has been added for stabilization. The modified device is available in diameters of form 38mm to 60mm, in one-millimeter increments.

AI/ML Overview

The provided submission for the "Cemented Femoral Head Resurfacing Device" (K021799) states clearly in the "Non-Clinical and Clinical Testing" section:

"None provided"

Therefore, based on the information given, there is no study described that establishes acceptance criteria or demonstrates the device meets such criteria. All the questions regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be answered from the provided document as no such testing was presented.

The device's clearance via 510(k) was based on its substantial equivalence to a legally marketed predicate device (Nelson resurfacing Head cleared by K983452), not on new clinical or non-clinical performance data. The current device is described as a modification of the predicate device, with the addition of a central post for stabilization, and similar materials, surface finishes, and processing.

Regulation Number and Section

§ 888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metallic resurfacing 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 resurfacing component made of alloys, such as cobalt-chromium-molybdenum.(b)
Classification. Class II.