(151 days)
- A ) A press fit implant for arthritic degradation of the metatarso-phalangeal joint that has resulted in disabling pain, limited motion and loss of the normal ambulatory function of the forefoot.
- B) Degenerative arthritis
- C) Rheumetoid arthritis
- D) Bunion deformity associated with arthritis of the metatarsal-phalangeal joint
- E) The titanium version is available for use only in patients susceptible to nickel chromium allergies.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth.
The document is a 510(k) clearance letter from the FDA for the "BioPro Hemi MP Joint." It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information and indications for use. It does not contain any details about a study conducted to demonstrate the device's performance against specific acceptance criteria.
§ 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.