(116 days)
The Sequel Ring Fixation System is indicated for both adults and pediatric patients for:
- Open and closed fracture fixation
- Pseudoarthrosis or non-union of long bones
- Limb lengthening by epiphyseal or metaphyseal distraction
- Correction of bony or soft tissue deformities
- Correction of segmental or nonsegmental bony or soft tissue defects
- Post-Traumatic joint contracture which has resulted in loss of range of motion
The Sequel® External Fixation System is a single-use modular external fixator consisting of implantable half pins and fixation wires and non-patient contact rings, struts, telescoping rods, threaded rods, posts, hinges, connection plates, twisted plates, threaded sockets, bolts, washers and nuts that are combined by the health care professional to construct different frame configurations based on patient anatomy and indicated use. The frame forms the support metalwork for the torsion wire used in fracture fixation and several other indications for long bone fixation procedures. The Subject device includes additional components (tabbed rings and struts) compared to the primary predicate. The tabbed rings and struts are substantially equivalent to the tabbed rings and struts in the secondary predicates. Special wrenches and accessories are included for the proper assembly of the components. The components of the frame are manufactured from titanium, stainless steel, and aluminum.
The provided FDA 510(k) summary for the Sequel External Fixation Device (K202833) does not describe acceptance criteria for an AI/CADe device or a study demonstrating such criteria.
This document pertains to a medical device (external fixation system), not an AI or CADe product. The information included in the summary focuses on demonstrating substantial equivalence to predicate devices through comparisons of:
- Intended Use and Indications for Use
- Technological Characteristics (materials, operating principle, components)
- Performance Testing (biocompatibility and bench testing in accordance with ASTM F1541-17, sterilization validation in accordance with ISO 17665-1:2006 and ISO/TS 17665-2:2009).
Since this is a filing for a physical medical device and not an AI/CADe system, the requested information regarding AI/CADe acceptance criteria, study details, ground truth, sample sizes for test/training sets, experts, and MRMC studies is not applicable and therefore not present in the provided text.
§ 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.