(17 days)
Futura Biomedical Classic Great Toe Implant is indicated for:
- Hallux limitus or hallux rigidus .
- . Painful rheumatoid arthritis
- Hallux abducto valgus associated with arthritis ●
- Unstable or painful joint from previous surgery .
The Classic Great Toe Implant is a double-stemmed silicone prosthesis, intended to supplement first metatarsophalangeal joint srthroplasty. The implant is designed to act as a dynamic joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.
The provided text is a 510(k) summary for a medical device called the "Classic Great Toe Implant." It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain any information regarding clinical studies, performance data, acceptance criteria, or ground truth establishment.
The document explicitly states that the device is substantially equivalent to a predicate device based on design characteristics and intended use, rather than clinical performance data from studies.
Therefore, I cannot provide the requested information. The document focuses on regulatory equivalence, not performance evaluation through studies.
§ 888.3720 Toe joint polymer constrained prosthesis.
(a)
Identification. A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.(b)
Classification. Class II.