(21 days)
The intended use of the Ortho Solutions UltOS Plating System fixation device(s) is to draw two or more aligned small bone fragments together to facilitate healing.
The Ortho Solutions UltOS Plating System is Indicated for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones in the feet, ankles, and toes skeleton.
This implant should only be used with the Ortho Solutions UltOS Plating System. Combination with other implants or instrumentation is not permissible.
The Ortho Solutions UltOS Plating System is not intended for spinal use.
The Ortho Solutions UltOS Plating System is designed to address a variety of indications in rearfoot, midfoot, and forefoot reconstuctive fixation surgery. The overall system is composed of Twelve(12) Plate Types that accept both a smaller 2.7mm and larger 3.5mm Locking/ Non-locking Screw ( in various lengths of 8mm thru 50mm) with all screw heads of uniform size to fit any plate type. The UltOS System 'Twelve(12) Plate Types' consist of the following:
1). A Arthrodesis Wedge Plate (AWP) in 5 sizes of 0, 2, 4, 6 & 8mm. plate wedge widths,
2). A General Fusion Straight Plate (GFS) in 2 sizes of a 2 & 4 screw hole plate.
3). A General Fusion "T" Plate (GFT) in 3 sizes of a 2, 4 & 6 screw hole plate.
4). A Metatarsophalangeal Plate (MTP) in 3 sizes, Left & Right, of a Small, Medium & Large plate size,
5). A Opening Wedge Locking Plate (OWL) in 6 sizes of 0, 3, 4, 5, 6 & 7mm plate wedge widths,
6). A Opening Wedge Plate (OWP) in 6 sizes of a 0, 2.5, 3, 4, 5 & 7mm plate wedge widths.
7). A Calcaneal Step Plate (CSP) in 3 sizes of 8, 10 & 12mm plate step heights.
8). A General Fusion "X" Plate (GFX) in 4 sizes of a Extra Small, Small. Medium & Large plate size,
9). A Lapidus Plate (LAP) in 4 sizes, Left & Right, of a 0, 2, 4 & 6mm plate offset heights,
10). A Rearfoot Reconstruction Plate (RRP) in 3 sizes of a 6, 8 & 14 screw hole plate.
11). A Tarsal Fusion Plate (TFP) in 3 sizes of a 12, 14 & 16mm plate length, and
12). A Universal Locking Plate (ULP) in 5 sizes of a 12, 16, 20, 24 & 30mm plate length.
Screw diameters of 2.7mm and 3.5mm with either Locking or Non-Locking features and Cannulated 3.5mm self tapping screws in various lengths are also included in the UltOS Plating System.
Associated instrumentation such as compression and distraction pliers, disposable drills & wires/guide wires, drill guides, T8 torx screwdrivers and ancillary instrumentation is available. All plates and screws are manufactured from Alloyed Titanium Ti-6Al-4V to ASTM F136. All plates, screws, drills and K-wires are offered both 'Sterile' and 'Non-Sterile' to the customer.
The provided text is a 510(k) summary for the Ortho Solutions UltOS Plating System, a medical device for orthopedic fixation. It discusses the device's description, intended use, and argues for its substantial equivalence to currently marketed devices.
However, the document states: "No nonclinical testing was used in the determination of substantial equivalence." This means that the submission does not contain any data from a study that proves the device meets specific acceptance criteria. The basis for regulatory clearance is substantial equivalence to predicate devices based on material, geometry, and indications, not on performance data from a specific study demonstrating compliance with acceptance criteria.
Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. The document explicitly states that no such testing was performed for this submission.
§ 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.