(31 days)
The Vilex External Fixation System is intended for external fixation with the following indications:
- Stabilization of Fractures & Osteotomy
- Rear and Mid-foot Arthrodesis
- Adult and Pediatric Leg Lengthening
- Correction of Bone Deformity in Upper & Lower Extremities
The Dynex® Ring Fixation System and Diametrix® Ring Fixation System fall within the Vilex External Fixation System product line. The systems consist of the following components:
- Dynex dynamic external fixation components (rings, footplates, and arches) or Diametrix static external fixation components (rings, footplates, and arches);
- Half pins and wires (regular and HA coated);
- Ball Markers for X-Ray;
- External fixation assembly hardware (e.g. wire fixation bolts, half pin bolts, struts, plates and posts, hinges, washers, support rods, and linear distractors); and
- Instruments (e.g. drills. drivers. tensioners. cutters, and benders).
The Dynex® Ring Fixation System components can be used as an external fixation and hexapod system, when configured with two or more rings and telescoping struts. The P&C CORA software (K151881) may be used in conjunction with the Dynex® Ring Fixation System to assist in pre-operative planning.
The Diametrix® Ring Fixation System components are traditional ring fixation components with frames that utilize tensioned wires and half pins.
Both systems utilize the same external fixation assembly hardware and instruments.
The Dynex rings, manufactured from aluminum, are offered in Full, 5/8, half and 3/8 sizes with footplates. The rings are circular with concentric inner and outer holes which provides versatility for hardware fixation points.
The Diametrix rings, manufactured from aluminum, are offered in in Full, 5/8, Half, and 3/8 sizes with footplates. The rings are tabbed which allows for multiple connection points and minimizes hardware interference.
The half pins and wires are constructed from stainless steel (ASTM F138 LVM). The coated half pins and wires are coated with Hydroxyapatite (HA). The half pins (Ø 3.0, 4.0, 4.5, 5.0, 6.0 mm) are provided in multiple lengths (60 – 200 mm) and are provided in sterile and non-sterile packaging. The wires are available in multiple designs (wire sharp bayonet, pear wire sharp bayonet, and wire bayonet olive) and are provided in 1.2. 1.5. and 1.8 mm diameters and range in length from 250 – 400 mm. The HA coated wires are provided sterile.
The external fixation rings, footplates, arches, struts, and assembly accessories are manufactured from stainless steel and anodized aluminum and are provided in various sizes to accommodate variations in patient size.
These components can be combined to create various frame assemblies.
The instruments and ball markers for X-Ray are manufactured from stainless steel.
This document (K202054) describes the Dynex Ring Fixation System and Diametrix Ring Fixation System. It is a 510(k) premarket notification, which means the manufacturer is claiming substantial equivalence to existing legally marketed predicate devices.
Crucially, this document states: "As the only differences between the subject and predicate devices are the product trade names, no additional performance data was submitted to demonstrate the substantial equivalence of the subject device to the predicate device."
Therefore, the provided document does not contain any information about acceptance criteria or a study that proves the device meets those criteria, as no new performance data was generated or submitted for this specific 510(k) clearance due to the nature of the submission (trade name changes only).
The information you are asking for (acceptance criteria, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, etc.) is typically found in the documentation for the predicate devices that underwent more rigorous testing, or for novel devices that require de novo classification or PMA approval. This 510(k) is a "piggy-back" submission relying on the prior clearances of its predicates.
To answer your request, I must state that the provided text does not contain the necessary information. It explicitly says "no additional performance data was submitted."
§ 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.