(486 days)
The Cannulated Metallic Toe Implant, as designed, has the following Indications for Use: Hallux Limitus or Hallux Rigidus, Hallux Valgus, Joint Arthroplasty, Resurfacing of Arthritic M-P Joints.
The material used to manufacture this prosthesis is implant-quality cobalt-chrome alloy ASTM F75. The implant may be cemented to the phalanx or press-fit without cernent.
This document is a 510(k) clearance letter from the FDA for a medical device called the "Cannulated Metallic Hemi Toe Implant." It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed subject to general controls.
Therefore, I cannot provide the requested information based on the provided text. The document is primarily a regulatory approval notice, not a performance study report.
§ 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.