(108 days)
The OSSIOfiber™ Hammertoe Fixation System/ OSSIOfiber™ Hammertoe Fixation Implant is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).
The OSSIOfiber™ Hammertoe Fixation Systems\OSSIOfiber™ Hammertoe Fixation Implants include implants that have a ribbed design that is inserted between the proximal and middle phalanges, so the ribs fixate on the phalangeal canal of the toe. The OSSIOfiber™ Hammertoe fixation implants are made of OSSIOfiber™ material which is degradable poly (L-lactide-co-D,Llactide) (PLDLA) reinforced with continuous mineral fibers. OSSIOfiber™ implants have been shown to be biocompatible. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made from minerals that are found in natural bone. As the OSSIOfiber™ implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.
The OSSIOfiber™ Hammertoe Fixation Implants are supplied sterile, pre-mounted on an implant inserter, offered in straight and 10-degree variations, and are available in several sizes: 16-21 mm long and 2.5-3.2 mm nominal diameter.
The OSSIOfiber "" Hammertoe Fixation System is a sterile kit which includes, in addition to the implant pre-mounted on an inserter, a drill bit and a k-wire which are the instrumentations required for the procedure.
The provided text is a 510(k) summary for the OSSIOfiber™ Hammertoe Fixation System. It explicitly states that the device is substantially equivalent to a predicate device (K190652) and that "There have been no changes to the device and the technological characteristics remain identical."
Therefore, the document does not describe acceptance criteria for this specific device (K201803) or any new study that proves it meets acceptance criteria.
Instead, it relies on the previous clearance of the predicate device (K190652) and confirms that the current device (K201803) has the "same intended uses, indications of use, material composition technological characteristics and principles of operation". The only new information mentioned is "Additional chemical characterization has been completed, and together with a toxicological risk assessment provide the basis for the labeling revision."
Consequently, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, as this document does not contain that level of detail for K201803. The focus of this 510(k) is on demonstrating substantial equivalence, not on presenting new performance studies for the device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.