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The ARTFX Trauma Bone Plate and Screw System is indicated for fixation of upper extremity (humerus, olecranon, radius, ulna, metacarpals, phalanges), lower extremity (femur, tibia, fibula, tarsals, metatarsals, phalanges), pelvis, and clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The ARTFX Trauma Bone Plate and Screw System is not intended for use in the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine, nor for fixation of the sacroiliac joint. The system is intended for single use and for adult patients only.

The ARTFX 3.5 System is indicated for the fixation of upper extremity (humerus, olecranon, radius, ulna, metacarpal, phalangeal), fibula, foot (tarsal, metatarsal, phalangeal), pelvis, and clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions.

The ARTFX 4.5 System is indicated for fixation of lower extremity (femur, tibia, fibula) and foot (tarsal, metatarsal, phalangeal) fractures, fusions, osteotomies, non-unions and reconstructions.

The ARTFX Mini-Plate System is indicated for fixation of hand (metacarpal, phalangeal) and foot (tarsal, metatarsal, phalangeal) fractures, fusions, osteotomies, malunions and reconstructions.

The subject ARTFX Trauma Bone Plate and Screw System is submitted as a bundled submission and consists of four sub-systems: the ARTFX 3.5 System, the ARTFX 4.5 System, the ARTFX Mini-Plate System, and the ARTFX Bone Screw System. The subject system consists of bone plates and screw that are used in the treatment of fractures, fusions, osteotomies, non-unions, malunions, and reconstructive surgeries of the upper extremity (humerus, olecranon, radius, ulna, metacarpals, phalanges), lower extremity (femur, tibia, fibula, tarsals, metatarsals, phalanges), pelvis, and clavicle. After fracture reduction, these devices provide stability and maintain the alignment of bone fragments throughout the healing process. Compression is used whenever possible to increase the contact area and stability between the fragments and reduce stress on the implant. Compression is achieved by using non-locking screws that are placed in compression slots or holes of the plate, allowing for compression of the bone fragments as the screws are tightened. The locking screws do not provide compression, as they are designed to lock into the plate and stabilize the bone fragments through fixed-angle constructs. The special feature of the subject devices is the free choice of screw placement. The user is able to set any desired screw in any hole (either using a locking or non-locking screw). The free choice of screw angulation provides an advantage in fracture treatment, especially in the case of complex fractures.

Generally, the subject plates are designed to the contour of their intended anatomical location and used with cortical, cancellous, non-locking, and cancellous subject screws. The subject bone plates and bone screws are manufactured from Titanium (Ti6Al4V-ELI) per ASTM F136. The subject devices are supplied non-sterile and must be steam-sterilized prior to use.

The subject plates of the ARTFX 3.5 System consist of the clavicle shaft locking plate combi hole, clavicle distal locking plate combi hole, clavicle hook locking plate combi hole, tubular locking plate, olecranon locking plate, olecranon hook locking plate, humerus distal medial locking plate, humerus distal posterolateral locking plate, humerus distal lateral locking plate, distal ulna locking hook plate, radius distal styloid plate, radius distal dorsal L locking plate, radius distal dorsal T locking plate, proximal radius locking plate, radius distal volar locking plate, radius distal volar locking plate small, radius distal volar locking plate TP2, distal ulna locking plate, small 3.5 compression plate combi hole, small 3.5 TP2 compression plate combi hole, humerus proximal locking plate combi hole, reconstruction shaft locking plate, pelvic reconstruction curving locking plate, pelvic reconstruction straight locking plate, pelvic symphyseal plate. The plates of this system range in thickness from 1.4mm to 4.0mm and in width from 6.0mm to 13.0mm.

The subject plates of the ARTFX 4.5 System consist of the tibia distal medial locking plate, tibia distal lateral locking plate, tibia distal lateral locking plate TP2, large broad T locking plate, large broad L support locking plate, small proximal femur plate, tibia proximal medial plate, large broad T support locking plate, tibia high osteotomy plate, large narrow locking plate, tibia proximal lateral locking plate, femur distal locking plate, femur proximal locking plate, large broad locking plate, fibula locking plate, fibula distal locking plate, calcaneus locking plate. The plates of this system range in thickness from 2.0mm to 5.5mm and in width from 9.5mm to 18.0mm.

The subject plates of the ARTFX Mini-Plate System consist of the 1.5mm system, 2.5mm system, and 2.7mm system. The 1.5mm system consists of the 1.5mm hand/foot mini locking strut plate, hand/foot mini H plate, hand/foot mini locking T plate head 3 holes, hand/foot mini locking straight plate, hand/foot mini straight plate non-locking, hand/foot mini locking Y plate, hand/foot mini locking condylar plate, hand/foot mini non-locking T plate, mini non-locking mallet finger plate, and mini locking T plate head 4 holes. The 2.0mm system consists of the 2.0mm hand/foot mini locking straight plate, hand/foot mini locking T plate, hand/foot mini locking condylar plate, hand/foot mini adaptation locking straight plate, and hand/foot mini adaptation locking T plate. The 2.5mm system consists of the 2.5mm hand/foot locking H plate, hand/foot mini locking straight plate, hand/foot mini locking condylar plate, foot locking X plate, hand/foot mini locking L plate oblique, hand/foot mini locking L plate, hand/foot mini adaptation locked straight plate, and hand/foot mini locking T plate 3 holes. The 2.7mm system consists of the 2.7mm hand/foot locking H plate, hand/foot mini locked straight plate, hand/foot mini locked T plate, hand/foot mini locking condylar plate, foot locking X plate, hand/foot mini locked L plate oblique, hand/foot mini locking L plate. The plates of the ARTFX Mini-Plate System range in thickness from 0.8mm to 2.5mm.

The subject screws of the ARTFX Bone Screw System consist of the locking self tapping cortical screw, non-locking self-tapping cortical screw, non-locking self tapping cancellous screw full thread, nonlocking self tapping cancellous screw half thread, non-locking self tapping spongiose screw half thread, cannulated compression screw, locking cannulated full thread screw, locking self tapping cancellous screw, headless cannulated full thread screw, cannulated cancellous Herbert screw stamps. The screws in this system ranges in major diameter from 1.5mm. The screw stamps have a thickness of 1.5mm and range in outer diameter from 6.0mm and inner diameter from 3.0mm to 7.8mm.

This is a 510(k) premarket notification for a medical device called the ARTFX Trauma Bone Plate and Screw System. This document does not contain information on acceptance criteria for an AI/ML device or a study proving that the device meets those criteria. The ARTFX Trauma Bone Plate and Screw System is a hardware device used for orthopedic trauma fixation and is not an AI/ML powered medical device. Therefore, the requested information points, such as sample size for test set, data provenance, expert qualifications, adjudication methods, MRMC study, standalone performance, training set sample size, and ground truth establishment are not applicable.

The document describes the device, its indications for use, and establishes substantial equivalence to predicate devices based on similarities in design, dimensions, performance criteria, materials, and sterilization methods. Non-clinical performance testing was conducted according to ASTM F382-17 and ASTM F543-23, and the device met the performance criteria outlined in FDA guidance for bone screws and plates. Biocompatibility was established by demonstrating the device's identity in formulation, processing, sterilization, and geometry to a previously cleared device (K212220 – ARTFX Spinal Fixation System).

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