MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION

• K Number: K070052
• Device Name: MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION
• Manufacturer: VILEX, INC.
• Date Cleared: 2007-03-28 ( 83 days)
• Product Code: KWD
• Regulation Number: 888.3730
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K023684 , K031859

Intended Use

Hallux Limitus or Rigidus
Resurfacing of Arthritic /Metatarsal joint
To fixate, use cement or press fit without cement

Device Description

The implant is a fixation metal device, machined from implant quality cobalt-chrome alloy. The implant is cannulated to allow proper positioning. The stem is threaded and functions as a selfreaming and self-tapping screw for easy insertion. The shaft design is a duplicate of Vilex Cannulated Hemi Implant, K023684. The head is spherical and mirror-polished. The outside appearance resembles the STD Great Toe Resurfacing Hemi-Arthroplasty Implant, K031859. Use Only with Approved Bone Cement
Auxiliary instruments for implanting, aligning, countersinking come with "The Met-head."

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, the Vilex™ Met-Head™, by the FDA. It details information about the device, its indications for use, and a comparison to predicate devices, but it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided document.

To be clear, the document is a 510(k) clearance letter from the FDA, which means the device was found to be "substantially equivalent" to a legally marketed predicate device. This process typically relies on demonstrating equivalence in design, materials, indications for use, and technological characteristics, rather than requiring new clinical studies with defined acceptance criteria for device performance. While the manufacturer would have internal testing to ensure the device meets its own specifications, these details are not part of this specific FDA clearance document.

Regulation Number and Section

§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.

(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.