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Moldable Bone Void Filler and Moldable Bone Void Filler + CCC is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Moldable Bone Void Filler and Moldable Bone Void Filler + CCC can be used with autogenous bone marrow. Moldable Bone Void Filler and Moldable Bone Void Filler + CCC resorbs and are replaced with bone during the healing process. Moldable Bone Void Filler and Moldable Bone Void Filler + CCC are for single patient use only.

Moldable Bone Void Filler and Moldable Bone Void Filler + CCC are bone void fillers composed of processed demineralized bone matrix (DBM), a synthetic macromer hydrogel, and cortical cancellous bone chips (CCC) for Moldable Bone Void Filler + CCC only. Both are provided with an accessory kit containing pre-measured hydrating solution and a spatula to mix the components. After the implant is hydrated, the resultant putty can then be handled and placed in the appropriate bone voids or gaps. Moldable Bone Void Filler and Moldable Bone Void Filler + CCC gradually resorb and are replaced with new bone during the healing process. At the 12 week timepoint, animal study data demonstrated new bone formation averages of 16.21% in the Optecure group, 13.8% in the Optecure + CCC group, 15.75% in the Exactech Optecure + CCC predicate group, and 12.08 % in the empty defect negative control group.

The EVOS Cabling System is intended to be used in general orthopaedic repair procedures including patellar fractures, general cerclage, trochanteric reattachment, femoral and tibial fractures, prophylactic banding, olecranon fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nail and screw fixation techniques.

The EVOS Cabling System is used in orthopedic trauma and reconstructive surgeries to reduce and stabilize fractures and osteotomies. The EVOS Cabling System may be used for supplementary fracture fixation when used with bone plates or screws. The EVOS Cabling System includes a sterile, stainless-steel cable implant (ASTM F1314) packaged together with a stainless-steel crimp (ASTM F138). Non-sterile, reusable instruments are also provided to facilitate proper implantation of the cable-crimp implant.

Streamline Navigated Instruments are intended to be used during the preparation and placement of screws from the Streamline TL and MIS Systems and preparation of screws from the Streamline OCT System during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT- or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Streamline Navigated Instruments are non-sterile, reusable instruments for use with the Medtronic StealthStation Navigation System to assist surgeons in precisely locating anatomical structures in either open or minimally invasive (MIS) procedures for preparation and placement of screws from the Streamline TL Spinal Fixation System and Streamline MIS Spinal Fixation System and preparation of screws from the Streamline OCT Occipito-Cervico-Thoracic System. The Streamline Navigated Instruments include pedicle finders, modular handle, taps, drills, and screw inserters designed for use with Streamline TL, Streamline MIS, and Streamline OCT Systems. The instruments are manufactured from stainless steel (ASTM F899).

The Tritium® Sternal Cable Plate System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures.

The Tritium® Sternal Cable Plate System includes implants of various sizes; plates and cable plugs comprised of commercially pure titanium, Grade IV (ASTM F67), and cables and screws comprised of Titanium 6AI 4V Alloy (ASTM F136). The system also includes needles comprised of Custom 470 stainless steel, 420 stainless steel (ASTM F899, Custom 470 SST) and leader comprised of Titanium 3AI/ 2.5V Alloy (ASTM F2146). The system is designed to enhance the stability and strength of traditional sternal closure techniques. Utilizing a unique load sharing concept, the device can be implanted to distribute lateral force across the osteotomy. The system can be used with traditional monofilament wire or Pioneer Sternal Cable. The device system should be implanted using only the manual surgical instruments designed specifically for this system of implants, which may be implanted via an open or minimally invasive approach.

The Streamline TL Spinal Fixation System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw (T1-S2), posterior hook (T1-L5) or sacral/iliac screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudarthrosis, and failed previous fusion.

The Streamline TL Spinal System consists of a variety of rods, screws (poly-axial, fixed, and reduction), rod connectors, crosslinks, set screws, hooks and other connecting components used to build a spinal construct. The implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The Streamline TL Spinal System includes Class I manual instrumentation to facilitate implantation of the device components.

When the Fortlink-A is used as a lumbar interbody fusion (IBF) implant, it is indicated for intervertebral body fusion of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This IBF device is used to facilitate interbody fusion in the lumbar spine from L1-L2 to L5-S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF device is intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) months of non-operative treatment with an interbody fusion device. Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation. When Fortilink-C is used as cervical interbody fusion (IBF) implants, these devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the cervical spine and are placed via an anterior approach from C2-C3 to C7-T1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The IBF devices are intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) weeks of non-operative treatment with an interbody fusion device. When Fortilink-TS and Fortilink-L are used as lumbar interbody fusion (IBF) implants, these devices are indicated for intervertebral body fusion of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L1-L2 to L5-S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF devices are intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an interbody fusion device.

The Fortilink® interbody fusion (IBF) devices are designed to be inserted into the intervertebral body space of the spine and are intended for intervertebral body fusion. These implants are manufactured from a radiolucent polymer (PolyEtherKetone (PEKK)) (ASTM F2820) which should support radiographic imaging inside the implant to evaluate fusion status and are assembled with radiographic markers composed of tantalum (ASTM F560) to facilitate proper implant position. The implant is provided sterile by gamma irradiation and is intended to be used with supplemental fixation cleared for the implanted level. The implant is supplied with instrumentation necessary to facilitate the insertion and removal of the implant, as well as qeneral manual surqical instruments. The implant is provided in different footpring heights to provide implant options best suited to an individual's pathology and anatomical condition.

When Fortilink®-C is used as cervical interbody fusion (IBF) implants, these devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the cervical spine and are placed via an anterior approach from C2-C3 to C7-T1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The IBF devices are intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) weeks of non-operative treatment with an interbody fusion device. When Fortilink®-TS and Fortilink®-L are used as lumbar interbody fusion (IBF) implants, these devices are indicated for intervertebral body fusion of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L1-L2 to L5-S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF devices are intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) months of non-operative treatment prior to treatment with an interbody fusion device.

The Fortilink® interbody fusion (IBF) devices are designed to be inserted into the intervertebral body space of the spine, and are intended for intervertebral body fusion. The purpose of this 510(k) is to seek marketing clearance for modifications to the straight and angled inserter tools for the Fortilink®-L device. The modifications include the following: Straight Inserter: Improve opening mechanism and disassembly prevention features Angled Inserter: - Apply an offset and angle to the inserter handle to align it with the Fortilink®-L . implant - Apply the same design changes (improved opening mechanism and disassembly ● features) as applied for the straight inserter

The CervAlign Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion.

The CervAlign Anterior Cervical Plate System is designed to promote cervical fusion by providing temporary resistance to flexion, extension, lateral bending, and axial rotation with strength and stiffness in the cervical spine (C2-C7). The system includes implants of various sizes of screws and plates to accommodate varying patient anatomies. The plates have integrated cover-style locking mechanisms that actuate to cover each screw. Implants are manufactured from titanium alloy, Ti-6Al-4V ELI instrumentation necessary to facilitate the insertion and removal. The implants and instruments are provided non-sterile and must be sterilized before use. Sterilization cases and trays are provided to facilitate proper sterilization and storage.

When Fortilink-C is used as cervical interbody fusion (IBF) implants, these devices are indicated for use in skeletally mature patients with degenerative disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the cervical spine and are placed via an anterior approach from C2-C3 to C7-T1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The IBF devices are intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) weeks of non-operative treatment with an interbody fusion device. When Fortilink-TS and Fortilink-L are used as lumbar interbody fusion (IBF) implants, these devices are indicated for intervertebral body fusion of the spine in sketally mature patients with degenerative disc disease (DD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L1-L2 to L5-S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF devices are intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an interbody fusion device.

The interbody fusion (IBF) devices are designed to be inserted into the intervertebral body space of the spine, and are intended for intervertebral body fusion. These implants are manufactured from a radiolucent polymer (PolyEtherKetoneKetone (PEKK)) (ASTM F2820) which should support radiographic imaging inside the implant to evaluate fusion status and are assembled with radiographic markers composed of tantalum (ASTM F560) to facilitate proper implant position. The implants are provided sterile by gamma irradiation and are intended to be used with supplemental fixation cleared for the implanted level. The implants are supplied with instrumentation necessary to facilitate the insertion and removal of the implants, as well as general manual surgical instruments. These implants are provided in different footprints and varying heights to provide implant options best suited to an individual's pathology and anatomical condition. The following designs are included in the Fortilink IBF System : - Fortilink-C IBF System - Fortilink-TS IBF System - Fortilink-L IBF System

The Streamline OCT Occipito-Cervico-Thoracic System is intended to provide immobilization of spinal segments as an adjunct to fusion when using autograft for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/ or traumatic dislocations; instabilitity of deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The system is 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, the Streamline OCT System may be connected to the Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System using connectors and/or transition rods.

The Streamline OCT System consists of a variety of rods, hooks, polyaxial screws, high-angle screws, locking caps, occipital plates, occipital screws, and connecting components used to build an occipito-cervico-thoracic spinal construct. System components are manufactured from ASTM F136 medical grade titanium alloy and ASTM F1537 medical grade cobalt chromium molybdenum alloy. Medical grade titanium alloy and medical grade cobalt chromium molybdenum alloy may be used together. The system should be implanted using only the surgical instruments designed for the system. Cases and caddies are supplied for sterilization and transport of the implants and instruments. The purpose of this submission is to modify and add components to the system.