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The QUARTEX® Occipito-Cervico-Thoracic Spinal System implants are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (CI-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radior myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. These implants are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, rods may be connected to occipital cervical thoracic or thoracolumbar stabilization systems ranging in diameter from 3.2mm to 6.5mm, using corresponding connectors. The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide to be used by surgeons for navigating compatible surgical instruments in open or percutaneous provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody spacers. The ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.

QUARTEX® additional implants include monoaxial, polyaxial, and dual lead polyaxial screws manufactured from titanium alloy; MIS rods manufactured from titanium alloy, stainless steel, and/or cobalt chromium molybdenum; and, associated manual and navigated surgical instruments. ExcelsiusGPS® Instruments are nonsterile, reusable instruments that can be used with ExcelsiusGPS® or ExcelsiusHub® and may be used for a navigated surgical procedure. No changes were made to the ExcelsiusGPS® or ExcelsiusHub® systems with the addition of the subject ExcelsiusGPS® instruments.

ADIRATM Lateral Plate System The ADIRA™ 2-Hole and 4-Hole Plates, when used with screws only, are intended for use in the treatment of thoracolumbar (T1-L5) spinal instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or failed previous spinal surgery. The ADIRA™ 1-Hole Plate is intended to stabilize allograft at one level (T1-L5), aiding in spinal fusion and to provide temporary stabilization and augment of a spinal fusion. It may be used alone or with other anterior, lateral, anterolateral, or posterior spinal systems. The device is not intended for load bearing applications. ADIRA™ Plate-Spacer Assemblies ADIRA™ Plates may be assembled to a lateral lumbar interbody fusion device (HEDRON® L, TransContinental®, RISE®-L, Modulus® XLIF, CoRoent®, or Cohere® XLIF Spacers) to create a plate-spacer assembly. When assembled to HEDRON® L, TransContinental®, or RISE®-L Spacers, the plate-spacer assembly is indicated for use at one or more levels of the lumbosacral spine (L1-L5), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. When ADIRA™ Plates are assembled to Modulus® XLIF, CoRoent®, or Cohere® XLIF Spacers, the plate-spacer assembly takes on the indications of the interbody device. ADIRA™ Plate-Spacers are intended to be used with screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, the 2-Hole or 4-Hole Plate-Spacers are intended for stand-alone use in patients with DDD at one or two levels only when <20° lordotic implants are used with two or four screws, respectively. ADIRA™ Plate-Spacers are to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.

The ADIRA™ Lateral Plate System consists of 4-, 2- and 1-hole thoracolumbar plates of various sizes to accommodate varying patient anatomy and surgical needs. The ADIRA™ plates are used with bone screws to attach to the anterolateral or lateral portion of the vertebral body of the thoracolumbar spine. ADIRA™ plates may also be attached to certain lateral lumbar interbody fusion devices (HEDRON L™, TransContinental™, RISE-L™, Modulus® XLIF, Cohere® XLIF, or CoRoent®) with an alignment screw. The plate-spacer assembly is used with bone screws and/or lateral anchors.

The STRETTO™ Cable System is indicated for use in: general orthopedic trauma surgery (e.g., fractures of the olecranon, patella, femur - including periprosthetic, pelvis, acetabulum, humerus and ankle, and acromioclavicular dislocations); prophylactic banding during total joint procedures; and, temporary reduction techniques for ORIF (Open Reduction Internal Fixation) procedures. STRETTO™ Screw Anchors are indicated for fractures that may not be securely held by either a screw or a cerclage device alone, and where cerclage is used in combination with bone screws and/or plates to provide internal fixation of fractured bone. STRETTO™ Press-In Anchors are indicated for use with a cerclage cable and plate to augment long bone fracture fixation, particularly when the use of screws would be inhibited, as in the presence of intramedullary implants.

The STRETTO™ Cable System implants are comprised of cables, crimps and anchors. Anchors include a thru hole for the cables to pass through, and are available in multiple styles. Press-in anchors mate with ANTHEM fracture plates and screw anchors mate with the hex recess of ANTHEM screws. The cable is secured with the crimp and may be used with the anchors. STRETTO™ Implants are manufactured from titanium alloy, commercially pure titanium, cobalt chromium alloy, cobalt chromium molybdenum alloy, or stainless steel.

CALIBER® Spacers are interbody fusion devices intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis. deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. All CALIBER® TPS coated spacers are indicated for the same use as non-coated PEEK spacers. CALIBER® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems). The RISE® Spacer is an interbody fusion device intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The RISE® Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. This device is intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). LATIS® Spacers are interbody fusion devices intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. LATIS® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems). The ALTERA® Spacer is an interbody fusion device intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The ALTERA® Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The MAGNIFY® Spacer is an interbody fusion device intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kvphosis), spinal stenosis, and failed previous fusion (pseudarthrosis), DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The MAGNIFY® Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone, and is to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). SABLE® Expandable Spacer is an interbody fusion device intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications; degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (6) months of non-operative treatment. The spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone and is to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The MONUMENT® Spacer is an interbody fusion device indicated for use at one or more levels of the lumbosacral spine (L1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). In addition, these patients may have up to Grade 2 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. All MONUMENT® TPS coated spacers are indicated for the same use as noncoated spacers. The MONUMENT® Spacer is to be used with four screws that accompany the implant. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). The MONUMENT® Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

CALIBER® Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. CALIBER® Spacers provide different shapes to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal [posterolateral] or lateral). The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. RISE® Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. RISE® Spacers are provided in different shapes to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal [posterolateral] or lateral) and can expand to the desired height. The implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. LATIS® Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. LATIS® Spacers are provided in a shape that accommodates a posterior, transforaminal, or lateral approach to the lumbar spine; after insertion the implant can be transformed to the desired footprint. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. The ALTERA® Spacer is an expandable lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The ALTERA® Spacer accommodates various surgical approaches to the lumbar spine (posterior or transforaminal [posterolateral]) and allows articulation upon insertion. The devices are available in various height ranges, allowing continuous expansion within the range, to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adiacent vertebrae to resist expulsion. MAGNIFY® Spacers are expandable anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. The devices are available in various height expansion ranges and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. SABLE® Spacers are expandable lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The devices are available in various heights and geometric options to fit the anatomical needs of a wide varietv of patients. The MONUMENT® Spacer is an anterior lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectorny. The MONUMENT® Spacer is intended to aid in reduction of a Grade 1 spondylolisthesis. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation.

The HILINE™ Fixation System consists of temporary implants for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: · Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques; · Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and spondylolisthesis; · Spinal degenerative surgery, as an adjunct to spinal fusions; · Use with a posterior spinal instrumentation construct when ligament augmentation is needed. The HILINE™ Fixation System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.

The HILINE™ Fixation System is a sublaminar fixation system consisting of bands and clamps to mate with 3.5-6.5mm diameter rods, and associated manual surgical instruments. The bands have a titanium anchor attachment on one end that is detached after insertion and is not intended to be implanted. HILINE™ implants are manufactured from polyethylene terephthalate (PET), titanium alloy, commercially pure titanium, stainless steel, or cobalt chromium molybdenum alloy.

MARVEL™ Growing Rods are indicated in patients under 10 years of age with potential for additional spine growth who require surgical treatment to obtain and maintain correction of severe, progressive, life threatening, early onset spinal deformities associated with thoracic insufficiency, including early onset scoliosis, as part of a growing rod construct.

MARVEL™ Growing Rods are posterior stabilization rods that can be surgically lengthened by manual mechanical actuation on a periodic basis as the patient grows. These rods are used as part of a growing rod construct consisting of MARVEL™ rods and screws, and are limited to a posterior approach. The rods include a tapered distal tip for a minimally invasive surgical approach. MARVEL ™ Growing Rods are manufactured from titanium alloy and PEEK.

HEDRON C® Spacers and HEDRON IC® Spacers are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with cervical disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. HEDRON C® Spacers and HEDRON IC® Spacers are intended to be used with supplemental fixation, such as an anterior cervical plate or posterior cervical fixation. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. When the HEDRON IC® Spacer is used with the COALITION AGX® Plate, the plate-spacer assembly (HEDRON IC® Plate-Spacer) is a stand-alone device intended for use at one or two levels of the cervical spine (C2-TI) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. These devices are to be used with two titanium alloy screws which accompany the implants (≥20°) must be used with supplemental fixation in addition to the two screws. HEDRON® Lumbar Spacers (HEDRON A™, HEDRON P®, HEDRON T™, and HEDRON RT™) are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T -T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be sketally mature and have had at least six (6) months of non-operative treatment. HEDRON® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation. HEDRON IA® Integrated Lumbar Spacers are integrated lumbar interbody fusion devices indicated for use at one or more levels of the lumbosacral spine (L1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DD), disc herniation (with myelopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. These devices are intended to be used with or without three screws and or anchors which accompany the implants. These devices are with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when <259 lordotic implants are used with three screws per implant. HEDRON IA® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. SABLE® Expandable Spacer is an interbody fusion device intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone and is to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems). The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for spationing and orientation of an instrument holder or guide tube to be used by surgeons for navigating compatible surgical instruments in open or percutaneous provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody spacers.

HEDRON® Cervical Spacers (HEDRON C® and HEDRON IC®) are anterior cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. HEDRONIC® Spacer may be assembled to the COALITION AGX® Plate to create the HEDRON IC® Plate-Spacer, a standalone cervical interbody fusion device. HEDRON® Spacers are additively manufactured from titanium allov. as specified in ASTM F3001. HEDRON® Lumbar Spacers are lumbar interbody fusion devices used to provide structural stability following discectomy. Each HEDRON® spacer has a different shape to accommodate various surgical approaches to the spine, including anterior, anterolateral, lateral, posterior or transforaminal approaches. All approaches are used in the lumbar spine; only anterolateral, or lateral approaches are used in the thoracic spine. HEDRON® Integrated Lumbar Spacers are integrated anterior lumbar interbody fusion devices used to provide structural stability following discectomy. They are used with or without screws and/or anchors. All HEDRON® Lumbar Spacers are additively manufactured from titanium powder. The mating screws and anchors are manufactured from titanium alloy and/or cobalt chrome alloy. Titanium screws and anchors are available with or without hydroxyapatite (HA) coating. The SABLE® Expandable Spacer is an expandable lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The device is available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. SABLE® Spacers are manufactured from titanium alloy. The endplates are additively manufactured from titanium alloy powder and an internal component is manufactured from radiolucent PEEK polymer. The drive screw is manufactured from cobalt chromium alloy. ExcelsiusGPS® Instruments are nonsterile, reusable instruments that can be operated with ExcelsiusGPS® and may be used for a freehand navigated surgical procedure.

The ONVOY™ Acetabular System is intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from: 1. Non-inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis, 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. The ONVOY™ Acetabular System is used in conjunction with Globus/Stelkast hip systems. The acetabular components of this system are intended for cementless fixation.

The ONVOY™ Acetabular System consists of shells, liners, and bone screws that are used as part of a complete total hip system in conjunction with a femoral head and femoral stem in total hip arthroplasty. Implants are available in various configurations and sizes to fit a wide variety of patient anatomy. Shells are available in a cluster hole design, liners are available in hooded and non-hooded designs used in conjunction with the shells, and bone screws provide additional fixation when inserted through the shell. ONVOY™ acetabular shells are manufactured from titanium alloy, with a commercially pure titanium vacuum sintered coating. The liners are manufactured from ultra-high molecular weight polyethylene (UHMWPE) with Vitamin E. Bone screws are manufactured from titanium alloy.

AUTOBAHN® EVO Femoral Nails are indicated for long bone fracture fixation in skeletally mature patients, specifically femoral fracture fixation, which may include the following: open and closed femoral fractures, pseudoarthrosis and correction osteotomy, pathologic fractures, impending pathologic fractures, tumor resections, supracondylar fractures, including those with intra-articular extension, ipsilateral hip/shaft fractures, ipsilateral femur/tibia fractures, fractures proximal to a total knee arthroplasty, fractures distal to hip joint, nonunions and malunions, poly trauma patients, fractures in the morbidly obese, fractures involving osteopenic and osteoporotic bone, compound and simple shaft fractures, proximal, metaphyseal, and distal shaft fractures, segmental fractures, closed supracondylar fractures, fractures involving femoral condyles, comminuted fractures with bone loss, and periprosthetic fractures. In addition, the AUTOBAHN® EVO Antearade Nails are intended for use in adolescents (12-21 years) in which the growth plates have fused.

The AUTOBAHN® Nailing System is a family of intramedullary nails, screws and washers designed to be used for internal bone fixation. The AUTOBAHN® EVO implants include femoral nails (antegrade and retrograde) and locking screws available in various lengths and diameters to accommodate a wide range of patient anatomy; the nails are secured with locking screws. Washers and nuts are also available. Devices are manufactured from titanium allov, cobalt chrome allov, and stainless steel.

The InstaFill™ Graft Delivery System is intended to be used for the delivery of allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

The InstaFill™ Graft Delivery System consists of a delivery device with an actuating handle, loading plunger, conical tip, and empty and pre-filled cartridges, designed to deliver graft material to an orthopedic surqical site. Cartidges are pre-filled with DBM or SIGNIFY® Gel. The delivery device and associated instruments are reusable, and the cartridges are provided sterile for single use. InstaFill™ components are manufactured from stainless steel, aluminum and PEEK, with polypropylene cartridges.