(30 days)
The Medline UNITE® REFLEX® Nitinol Staples are intended to provide fixation for fractures of the bones of the hand and foot such as: First metatarsalcunerform arthrodesis, First metatarsophalangeal arthrodesis, Talo-Navicular Fusion, LisFranc arthrodesis, Akin osteotomy, Scarf and Chevron osteotomies. Staples are intended for single use only.
The Medline UNITE® REFLEX™ Nitinol Staples are manufactured from nickel titanium alloy (Nitinol). The staples utilize chemical etching and passivation to form a protective oxidation layer on the outer surface. Chemical etching and passivation are common processes to create a uniform oxidation layer on the surface of the implant. The kits includes staples offered in a range of sizes from 8mm x 8mm to 25mm x 25mm. The Medline UNITE® REFLEX® Nitinol Staples are offered in three different bridge widths. The MINI features a 1.5mm bridge width, the MAX has a 4.0mm bridge width and the ULTRA has a 5.0mm bridge width. The MAX and ULTRA staples have a chamfer on the bridge that is not present on the MINI version of the staples.
The requested information about the acceptance criteria and study proving the device meets them is not available in the provided text. The document is an FDA 510(k) clearance letter for a medical device (Medline UNITE® REFLEX® Nitinol Staple Kit), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for clinical or standalone performance.
The provided text only mentions:
- Summary of Non-Clinical Testing (Bench):
- Elastic Static Bend and Constant Amplitude Bending Fatigue Testing per ASTM F564
- Pullout Strength Testing per ASTM F564
- Corrosion Susceptibility Testing per ASTM F2129
- Bacterial endotoxin testing using the Limulus Amebocyte Lysate (LAL) kinetic chromogenic assay, demonstrating the device meets the recommended maximum endotoxin level of 20 EU per device.
- Performance Testing (Animal): This section does not apply. No animal testing was performed.
- Performance Testing (Clinical): This section does not apply. No clinical testing was performed.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the given document.
§ 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.