(29 days)
2.4 SmartNail is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.
2.4 SmartNail is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the hand), 2) Fractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection; patient conditions, including blood supply limitations, insufficient quantity or quality of bone; and where patient cooperation cannot be guaranteed, (e.g., alcoholism) 4) Treatment of physeal fractures in children, because the effect of 2.4 SmartNail upon the healing of growth plate has not been tested clinically.
The device description of the 2.4mm SmartNail implant is as follows.
- The implant is composed of poly-96L/4D-lactide copolymer. This is the very same implant raw material with SmartNail (K993074) and 1.5mm Bone Fixation Kit (K012000, K013546)
- Lengths of implant are 16, 25, 35 and 45 mm. The current product selection of SmartNail products contains 16, 20 and 25 mm long implants. The current product selection of 1.5mm Bone Fixation Kit contains 14, 16, 18, 20 and 25mm long implants
- Diameter of implant is 2.4 mm.
- Shelf life is same with SmartNail™ and 1.5mm Bone Fixation Kit (K012000, -K013546), 3 years.
- Our current packaging style of SmartNail is that aluminium pouch is inner and tyvek®-pouch is outer pouch, implant is placed into cardboard holder. This packaging method is identical for 1.5mm and 2.4 SmartNail implants.
The only modifications that were made are:
- Amendment of one new sizes, 2.4mm in diameter and lengths of 16, 25, 35 and 45 mm
- Revision of design accordingly in longer lengths, more rows of barbs than in shorter nails
- Reference numbers for new sizes. These changes are updated in labelling.
- Revision of instrumentation accordingly
- Amendment of optional silicone cover for improvement of arthroscopic surgical technique
The provided text describes a 510(k) premarket notification for a medical device (2.4 SmartNail) and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The document is a regulatory submission for premarket clearance, focusing on demonstrating substantial equivalence to existing devices rather than presenting detailed performance studies against defined acceptance criteria.
Therefore, I cannot provide the requested information. The document focuses on:
- Device Description: Material, dimensions, shelf life, packaging, and modifications compared to predicate devices.
- Intended Use and Contraindications: What the device is designed for and situations where it should not be used.
- Predicate Devices: Identifying similar devices already on the market.
- Substantial Equivalence Claim: Stating that the modifications do not raise new safety or efficacy concerns and do not affect pull-out properties (though no specific data proving this is provided in the excerpt).
- FDA Clearance Letter: Confirming the substantial equivalence determination and allowing marketing.
To answer your questions, a different type of document, such as a detailed technical report, clinical study protocol, or performance testing summary, would be needed.
§ 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.