(127 days)
The indications for the OrthoFlex Rod include:
- Semi-rigid or rigid hammertoe deformity associated with degenerative arthritis
- Semi-rigid or rigid hammertoe deformity associated with rheumatoid arthritis
- Revision of a failed arthroplasty or arthrodesis
The OrthoFlex Rod design is a double-stemmed flexible implant designed for the proximal interphalangeal joint of the lateral toes. It is made of silicone elastomer, and is constructed in a rod-shaped design with a thicker mid-section spacer or collar.
This OrthoFlex Rod 510(k) summary explicitly states that "No clinical studies were performed" and therefore no acceptance criteria or studies proving device performance against such criteria are provided in the document.
The submission focuses on establishing substantial equivalence to predicate devices based on intended use, design, material, and function, rather than demonstrating performance through clinical studies and predefined acceptance criteria.
Therefore, the requested tables and information cannot be generated from the given text.
§ 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.