(74 days)
The SURFIX® Knee Osteotomy System is intended for open and closed wedge osteotomies of the proximal tibia and the distal femur, treatment of bone and joint deformities, and malalignment caused by injury or disease such as osteoarthritis.
The SURFIX® Knee Osteotomy System is indicated for knee osteotomies including high tibial osteotomy and femoral osteotomy in the cases of osteoarthritis of the medial tibiofemoral compartment with genu varum and lateral gonarthrosis on genu valgum. Examples include:
- Fixation of opening wedge high tibial osteotomy,
- Fixation of fracture of the medial tibial plateau,
- Osteoarthritis of the medial tibiofemoral compartment with genu varum,
- Fixation of closing wedge high tibial osteotomy,
- Fixation of fracture of the lateral tibial plateau,
- Distal femoral varus osteotomy,
- Lateral gonarthrosis on genu valgum.
The SURFIX® Knee Osteotomy System consists of seven different Stainless Steel plates with a locking system between the threaded sockets of the plates and the lock screws. There are six plates for the proximal tibia and one plate for the distal femur. Their fixation is provided by Titanium alloy or Stainless Steel SURFIX® screws and lock screws available in two versions: cancellous bone screws diameter 6.5 mm and cortical bone screws diameter 4.5 mm. The SURFIX® system fixation creates a single implant/screw unit fixed into the bone thanks the lock screw.
The provided document describes a medical device, the SURFIX® Knee Osteotomy System, and its substantial equivalence to predicate devices, but does not contain information related to acceptance criteria, a study proving device meeting acceptance criteria, or any of the detailed study parameters requested in the prompt.
The document is a 510(k) summary for premarket notification to the FDA. It details:
- Sponsor Identification
- Device Name, Classification, and Product Code
- Device Description: Consists of Stainless Steel plates with a locking system and Titanium alloy or Stainless Steel screws.
- Intended Use and Indications for Use: For open and closed wedge osteotomies of the proximal tibia and distal femur, treatment of bone and joint deformities, and malalignment caused by injury or disease such as osteoarthritis. Specific examples are given.
- Predicate Devices: Synthes TomoFix™ Osteotomy System (K023941) and Arthrex Modified Osteotomy System (K014155).
- Comparison of Characteristics: Mentions material differences between the SURFIX system and predicate devices (e.g., SURFIX uses Stainless Steel plates with Titanium alloy/Stainless Steel screws, while predicates use Stainless Steel or Titanium alloy for both).
- Summary of Studies: "Dynamic tests determining fatigue strength indicate the good mechanical resistance of the SURFIX® Knee Osteotomy System. Static tests determining bending strength in flexion and twisting of bone plates indicate the similar mechanical behavior of the SURFIX® Osteosynthesis System with a common plate."
Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone studies, or detailed ground truth information because this information is not present in the provided text.
The 'studies' mentioned are physical/mechanical tests (fatigue and bending strength) to ensure the device's structural integrity and similar mechanical behavior to a "common plate," but no specific quantitative acceptance criteria or detailed study results are provided beyond a general statement of "good mechanical resistance" and "similar mechanical behavior." There is no mention of clinical studies, human readers, AI, or diagnostic performance metrics.
§ 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.