(90 days)
External Fixation System components are intended to be used on adults or pediatric patients as required and are intended to be used for fracture fixation (open and closed); post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction: pseudoarthrosis or non-union of long bones; limb lengthening by epiphyseal or metaphyseal distraction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; joint arthrodesis; and management of comminuted intra-articular fractures of the distal radius.
External fixation devices, such as the external fixation bar clamps described herein, are specially designed components used in the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. The metal alloys used in their manufacture are chosen to address a wide range of applications. These devices have been designed to allow for the appropriate amount of rigidity and stability.
The provided text is a 510(k) Summary for External Fixation Systems. This type of document is for medical devices that are found to be substantially equivalent to a predicate device and typically does not include detailed studies with acceptance criteria, sample sizes, expert ground truth adjudication, or AI performance metrics.
The document states:
- "The principle of operation of these reprocessed devices is very similar to that of the predicates. There are no changes in intended use, performance specifications or method of operation. The reprocessed devices utilize similar designs, the same materials and technological characteristics when compared to the predicate devices."
- "The intended use of the reprocessed external fixation bar clamps is identical to that of the Smith & Nephew Unilateral Fixator (K994143) and the Smith & Nephew Unilateral Wrist Fixator for Distal Radius Fractures (K994143). The design and the function of the subject devices are very similar to the predicate devices and they are manufactured from the same materials."
Based on this, the device is considered substantially equivalent to existing predicate devices (Smith & Nephew Unilateral Fixator K994143 and Smith & Nephew Unilateral Wrist Fixator for Distal Radius Fractures K994143) because there are no changes in intended use, performance specifications, or method of operation. Therefore, a new study to prove device performance against specific acceptance criteria, in the way a novel AI device might, is not presented or required for a 510(k) submission of this nature.
Thus, I cannot provide the specific information requested in the format of a table of acceptance criteria, reported device performance, sample sizes, expert qualifications, or AI-related metrics because the document does not contain this type of study. The demonstration of safety and effectiveness for this device relies on its substantial equivalence to previously cleared devices.
§ 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.