(90 days)
The SOLUSTAPLE® is intended to be implanted for fixation of bone fractures or for bone reconstructions.
The SOLUSTAPLE® is indicated for:
● Akin type osteotomy
The SOLUSTAPLE® is a staple with two self-drilling tips. The treatment with a Solustaple allow, after possible treatment of the second ray, to recreate a square or Greek foot. Two types of staples are available. In order to safeguard the fonction of the joint, the staple with oblique design will be used.
This submission is a 510(k) premarket notification for the SOLUSTAPLE®, a bone fixation staple, and therefore does not contain details about acceptance criteria or specific study results to prove meeting those criteria. The primary purpose of a 510(k) is to demonstrate substantial equivalence to a predicate device, not to establish new safety and effectiveness standards through comprehensive clinical trials with pre-defined acceptance criteria.
The provided documents indicate:
- Predicate Device: The SOLUSTAPLE® is substantially equivalent to the Depuy, Inc. Varisation Staple.
- Technological Characteristics Comparison: Both staples are made of stainless steel conforming to ASTM F138 & F139 for bone fixation. This comparison of material properties is the extent of the "proof" provided for the 510(k) submission.
Therefore, the requested information components related to acceptance criteria, specific study designs, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this type of regulatory submission. The FDA clearance is based on the material equivalence and intended use comparison.
No study details are provided in this 510(k) submission. The FDA's decision is based on the comparison of technological characteristics to a predicate device already legally marketed.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.