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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.

The ARTFX Lumbar PEEK Cages are indicated for intervertebral body fusion at one or two contiguous levels in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received at least six (6) months of prior non-operative treatment. The devices are designed to be used with supplemental fixation and autograft/autologous bone grafts to facilitate fusion for each spinal region.

The ARTFX Lumbar PEEK Cages consist of 3 different models: TLIF, PLIF and Expandable PLIF. The System implants are supplied sterile, for single use and are fabricated from PEEK Optima that conforms to ASTM F2026. Various sizes of these components are available. The Lumbar Cages are lumbar intervertebral devices to be implanted into the appropriate lumbar vertebral section to help provide stability for spinal fusion after a diseased lumbar disc producing back pain is removed during spinal decompression. ARTFX Lumbar PEEK Cages feature an open cavity to accommodate autogenous bone graft and provide stability for fusion. The height of the Expandable PLIF device, can be increased by up to 2 mm due to the expandable structure. Also, sharp teeth on the implant's surface engage the vertebral endplates to prevent cage migration.

ARTFX MEDICAL Cervical PEEK Cages are made to be implanted into the appropriate vertebral section to help provide stability for spinal fusion after a diseased cervical disc producing neck and/or arm pain is removed during spinal decompression for patients who have had six weeks of nonoperative treatment. Cervical PEEK Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Cervical PEEK Cages facilitate intervertebral body fusion in the cervical spine and are placed via the anterior approach and packed with autogenous bone. ARTFX MEDICAL Cervical PEEK Cages are to be used with supplemental fixation.

"Cervical Peek Cage" refers to a type of intervertebral cage used in spine surgery in the cervical (neck) region. ARTFX Cervical Cages cervical intervertebral devices made from PEEK Optima (per ASTM F2026) are created to be implanted into appropriate vertebral sections to help provide stability for spinal fusion after a diseased cervical disc-producing neck and/or arm pain is removed during spinal decompression for patients who have had six weeks of non-operative treatment. Cervical peek cages are often used in spinal fusion surqeries. Fusion surgeries are designed to fuse two vertebrae. The single-use implant devices feature an open cavity in the interior geometry to accommodate autogenous bone graft and maximize bone growth, with anti-migration teeth to engage the vertebral end plates and prevent expulsion. The ARTFX Cervical Cages are supplied sterile, single-use, and are fabricated from PEEK that conforms to ASTM F2026 for cages, and with markers and pins that are titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136. ARTFX En Vivo Spinal Cervical Peek Cage has a peek cage body. Components of the ARTFX En Vivo Spinal cage have two pins, which assist in the positive anchorage of the implant between the superior and inferior vertebral bodies, and three radiographic markers. ARTFX Simplex Spinal XI Cervical Locking Peek Cage has a peek cage body. Components of ARTFX Simplex Spinal XI Cervical Locking Peek Cage has two titanium screws which the system is attached to the cervical spine and a titanium locking screw. Cervical cages consist of 3 models: En Vivo Anatomical Surface, En Vivo Straight Structure, and Simplex.

ARTFX SPINAL FIXATION SYSTEM is intended for use in the noncervical spine. When used as an anterior anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the ARTFX SPINAL FIXATION SYSTEM is intended to provide additional support during fusion using autograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: -Degenerative dise disease (DDD) (defined as back pain of discogenic origin with degeneration of the dise confirmed by history and radiographic studies): . -Spondylolisthesis; - Trauma (i.e. fi acture or dislocation); -Spinal stenosis: - -Curvatures (i.e. scoliosis, kyphosis, and/or lordosis) - Tumor: - -Pseudoarthrosis; and Failed previous fusion

The Proposed system is a top-loading multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, monoaxial pedicle screws, cannulated screws , rods (Straight and pre-bent) , connectors , hooks and setscrews. The Artfx Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. ARTFX SPINAL FIXATION SYSTEM is supplied non-sterile, single use and fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136.

The Venus Cervical Plate System is intervertebral screw fixation of the cervical spine at levels C2-T 1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: -Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) -Trauma (including fractures) -Tumors -Deformities or curvatures (including kyphosis, lordosis, or scoliosis) -Pseudarthrosis -Failed previous fusion -Decompression of the spinal cord following total or partial cervical vertebrectomy -Spondylolisthesis -Spinal stenosis.

The Venus Cervical Plate System is supplied non-sterile, single use and are fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136. Various sizes of these components are available. The Venus Cervical Plate System configurations ranging in lengths from 17 mm to the one-level plates, 27 mm to 40 mm for the two-level plates, 45 mm for the three-level plates, , and 70 mm to 90 mm for the four -level plates. All of the plate levels incorporate blocking mechanism to aid in prevention of bone screw back-out. The bone screws are provided with fixed angles available in self- tapping design. The fixed bone screws are inserted at a defined angle. The bone screws are offered in 3.5 mm, 4.0 mm and 4.50 mm diameters in lengths of 12 mm – 22 mm. The implants (bone screws and cervical plates) are provided as single-use, non-sterile devices manufactured from implantable grade titanium alloy (TI6Al4V-ELI). The Venus Cervical Plate System is intended for use as an aid in cervical spinal fusion . The Venus Cervical Plate System is supplied non-sterile, single use and are fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136. Various sizes of these components are available.