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FitboneTM Trochanteric is indicated for limb lengthening of the femur. FitboneTM Trochanteric is indicated for adult and pediatric (greater than 12 through 21 years of age) patients.

FitboneTM Trochanteric is a fully implantable intramedullary lengthening nail and accessories. The subject Fitbone Trochanteric consists of the implantable intramedullary lengthening nail and accessories (Locking screws, Trial nails K-wire and Convenience kits). The subject device is implanted into the medullary canal of the femur and connected to the primary predicate intracutaneous Receiver (K203399) by a bipolar feed line. The external FITBONE Control Set is the same as previously cleared for the reference device Fitbone TAA (K203399) and consists of a control electronics station and transmitter. The power required for the distraction process is controlled by hermetically enclosed motor which draws the telescope apart. The electro-magnetic field sent from the Transmitter to the Receiver is converted in the Receiver into DC-Voltage to supply the motor of the subject Fitbone Trochanteric Nails with voltage, when actioned. The subject Fitbone Trochanteric Nails are available in two different diameter models (D09mm, D11mm), different lengths and lengthening capabilities. The subject nail is anchored to the bone by locking screws. The locking screws to be used with the subject nails are the same as cleared for the primary predicate Fitbone Trochanteric (K233867). Trial nails accessories are available for each variant of the Fitbone Trochanteric nails and are used to simulate the shape of the implant. The Fitbone Trochanteric nail and K-wire are provided in sterile conditions only. The trial nails are provided in non-sterile version only. The locking screws are available in both sterile and non-sterile versions. The subject Fitbone Trochanteric Nails and their accessories are made from implant grade stainless steel 1.4441 (AISI 316LVM) and Silicone Nusilmed.

The OrthoNext™ Platform System is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery and post-operative planning of orthopedic treatment. The device allows for overlaying of Orthofix Product templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgments and experience are required to properly use the software.

The subject OrthoNext™ Platform System is a web-based modular software system, indicated for assisting healthcare professionals in planning of orthopedic surgery and treatment both preoperatively and postoperatively, including deformity analysis and correction with several Orthofix products. The subject software system is intended for use by Healthcare Professionals (HCP), with full awareness of the appropriate orthopedic procedures, in the operating theatre only. The subject software functions are intended to inform the HCP on orthopedic procedure treatment planning when the Orthofix external or internal fixation systems are used. These functions are evidence-based tools that support HCP when considering treatment digital planning options for a patient. The software functions do not treat a patient or determine a patient's treatment. The software enables the HCP to import radiological images, display 2D views (frontal and lateral) of the radiological images, overlay the positioning of the template and simulate the treatment plan option, and to generate parameters and/or measurements to be verified or adjusted by the HCP based on their clinical judgment.

TrueLok Elevate is intended for treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities. The TrueLok Elevate is indicated for adult and pediatric (greater than 2 through 21 years of age) patients.

The subject TrueLok Elevate is an external fixation component system (including its accessories) to be used with the Orthofix TrueLok family, for which Orthofix identified as a predicate device TrueLok Hexapod System (TL-HEX) V2.0 (K170650). The subject device consists in a further series of elements for external fixation added to the Orthofix TrueLok family with the aim of supporting the Orthofix TrueLok external fixator systems family falling within the indications for use of the more extensive, cleared indications for use of the chosen predicate device, for the specific use in bone transport treatment. The subject TrueLok Elevate is intended for treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities. The TrueLok Elevate is indicated for adult and pediatric (greater than 2 through 21 years of age) patients. The subject device is constituted by an external fixator and related accessories (half pins, k-wires, drill positioning guide, template and template inserts and convenience kits). The technique for the use of the subject device consists in fixing two half pins on the first cortical of the bone segment that the surgeon decided to transport, and two half pins on both cortexes of the bone. The positioning of the half pins is driven by a template. During the treatment, through the knob present on the device, the bone segment is gradually pulled outward by the patient/caregiver to laterally transport the bone segment. The subject device, as the predicate, will be implanted only by Healthcare Professionals (HCP), with full awareness of the appropriate orthopedic procedures (including application and removal), in the operating theatre only. The distraction of the limb will be activated in home by the patient/caregiver or in clinic theatre by the HCP. Treatment activation for pediatric patients in the home environment may require the assistance of a caregiver.

The M6-C™ Single Use, Disposable Instrumentation are intended for the placement and positioning of the M6-C Artificial Cervical Disc.

The M6-C™ Artificial Cervical Disc is an intervertebral disc prosthesis designed to permit motion of a functional spinal unit in the cervical spine when replacing a degenerated native disc (PMA P170036). The surgical implantation of the M6-C Cervical Artificial Disc requires specific surgical instruments including: a footprint template and a trial to determine the appropriate size and position of the implant; a fin cutter to create tracks in the superior and inferior vertebral endplates; and an implant inserter to place the artificial disc into the desired position to aid in and ensure correct placement within the intervertebral space. Additionally, these are general surgical instruments to assist in the distraction and mobilization of the disc space. The single use instruments are composed primarily of reinforced polyacrylamide (PAA+50%GF) with some structural components made from surgical stainless steel and are intended to be reusable.

Reef TO/TA System: When used as an intervertebral body fusion device, the Reef TO/TA System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fission and supplemental fixation. Regatta Lateral System: Interbody Device (IBD) Implants (i.e., interbody implants used alone): The Regatta Lateral System with NanoMetalene® surface technology is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at ether one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The Regatta Lateral System is intended for use with supplemental fixation. TruProfile Interbody Implants: The Regatta Lateral System assembled with the TruProfile Lateral Plate, when used with Screws, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graff and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The Regatta Lateral System assembled with the 1 - hole TruProfile Lateral Plate, when used with Screws, is intended for use with supplemental fixation. Explorer TO System: When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in sketally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation. WaveForm C Interbody System: The WaveForm C Interbody System are interbody fusion devices intended for use in skeletally mature patient with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels. DDD is defined as discogenic 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) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. When used as a standalone system, the WaveForm C Interbody System, which includes the 2,3,4-hole TruProfile plates and 2-hole No-profile interfixated spacer, is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1) and must be used with bone screw fixation and locking covers. When the WaveForm C Interbody (excluding 2-hole No-profile interfixated spacer) is used with supplemental fixation, such as anterior cervical plates, the WaveForm C Interbody System is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1). WaveForm TO Interbody System: When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cortical, cancellous, and/or corticocancellous bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation. WaveForm TA Interbody System: When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cortical, cancellous, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation. FORZA XP Expandable Spacer: FORZA XP Expandable Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). FORZA XP Expandable Spacer System is intended for use with autograft comprised of cancellous, cortical, and/or corticocancellous bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation. Patients must have undergone a regimen of at least six months of non-operative treated with FORZA XP Expandable Spacer System. Shoreline ACS and RT Interbody System: Shoreline ACS Interbody System: The Shoreline ACS Interbody System with NanoMetalene® surface technology are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature had at least six (6) weeks of non-operative treatment. These devicesare to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion. When used as a standalone system, the Shoreline ACS Interbody System, which includes the TruProfile plates and Noprofile spacer, is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1) and must be used with bone screw fixation and locking covers. The Shoreline ACS interbody spacers with > 20° lordosis are intended to be used with supplemental fixation. When the Shoreline ACS Interbody (excluding the No-profile spacer) is used with supplemental fixation, such as anterior cervical plates, the Shoreline ACS Interbody System is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1). Shoreline RT Interbody System: The Shoreline RT Interbody System with NanoMetalene® surface technology are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels. DDD is defined as discogenic 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) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. When used as a standalone system, the Shoreline RT Interbody System, which includes the TruProfile plates, is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the (C2-T1) and must be used with bone screw fixation and locking covers. The Shoreline RT interbody spacers with ≥ 20° lordosis are intended to be used with supplemental fixation. When the Shoreline RT Interbody System is used with supplemental fixation, such as anterior cervical plates, the Shoreline RT Interbody System is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1). Meridian Interbody System: Interbody Device (IBD) Implants (i.e., interbody implants used alone): The Meridian System with NanoMetale@ surface technology when used with or without a Spin Plate, is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The interded to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The Meridian Interbody is intended for use with supplemental fixation. No-Profile Interbody Implants with Screws: The Meridian System 2-Hole No-profile Interbody, when used with Screws and with or without a No-profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion. The Meridian System 2-Hole and 3-Hole No-profile Interbody must be used with the maximum number of screws allowed. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation. The Meridian System 4-Hole No-profile Interbody, when used with or without a No-profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The Meridian System 4-Hole No-profile Interbody may be used as a standalone device only when at least two Screws are inserted with one inferior and one superior screw traiectory. If the surgeon chooses to use the 4-Hole No-profile Interbody with fewer than two Screws inserted with one inferior and one superior screw trajectory, then additional supplemental fixation system must be used. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation. No-Profile Interbody Implants with Inline Fixation Anchors: The Meridian System No-profile Interbody, when used with Inline Fixation Anchors and a No-profile Locking Cover, is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The Meridian System No-profile Interbody with Inline Fixation Anchors is intended for use with supplemental fixation. TruProfile Interbody Implants: The Meridian System TruProfile Interbody assembled with the Anterior Plate, when used with Screws, an Anterior Plate Locking Cover, and with or without a Spin Plate, is a standalone indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation. WaveForm A Interbody System: Interbody Device (IBD) Implants (i.e., interbody implants used alone): The WaveForm A System Interbody, when used with or without a Spin Plate, is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The WaveForm A System Interbody is intended for use with supplemental fixation. No-profile Interbody Implants with Screws: The WaveForm A System 2-Hole and 3-Hole No-profile Interbody, when used with Screws and with or without a No-profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed cancellous, cortical, and/or corticocancellous bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The WaveForm A System 2-Hole and 3-Hole No-profile Interbody must be used with the maximum number of screws allowed. Hyperloriosis sizes (greater than 20°) are intended for use with supplemental fixation. The WaveForm A System 4-Hole No-profile Interbody, when used with Screws and with or without a No-profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-overative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The WaveForm A System 4-Hole No-profile Interbody may be used as a standalone device only when at least two Screws are inserted with one inferior and one superior screw traiectory. If the surgeon chooses to use the 4-Hole No-profile Interbody with fewer than two Screws inserted with one inferior and one superior screw trajectory, then additional supplemental fixation system must be used. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation. No-profile Interbody Implants with Inline Fixation Anchors: The WaveForm A System No-profile Interbody, when used with Inline Fixation Anchors and with a No-profile Locking Cover, is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The WaveForm A System No-profile Interbody with Inline Fixation Anchors is intended for use with supplemental fixation. TruProfile Interbody Implants: The WaveForm A System TruProfile Interbody assembled with the Anterior Plate, when used with Screws, an Anterior Plate Locking Cover, and with or without a Spin Plate, is a standalone indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft composed of cancellous, cortical. and/ or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.

Reef TO/TA System: The Reef TO/TA Interbody System featuring NanoMetalene® surface technology consists of straight, rectangular-shaped (Reef TO) and curved, banana-shaped (Reef TA), posterior lumbar intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026) with tantalum (per ASTM F560) markers for radiographic visualization and NanoMetalene, which is a one-micron thick surface laver of commercially pure titanium (per ASTM F67) that provides a microscopic roughened surface with nano-scale features. The interbody spacers are available in a variety of footprints, and lordotic options to accommodate variations in pathology and patient anatomy and include a central graft window for receiving autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical. and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The spacers are individually packaged and gamma sterilized. The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components. Regatta Lateral System: The Regatta Lateral System featuring NanoMetalene surface technology consists of lateral lumbar intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (ASTM F2026) with from tantalum (per ASTM F560) radiographic markers and a one-micron thick surface layer of commercially pure titanium (per ASTM F67). The interbody spacers are available in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy and include central graft windows for receiving autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation. The spacers are individually packaged and gamma sterilized. The Regatta Lateral interbody spacers can be used alone with supplemental fixation or in combination with fixation implants (i.e., plates, screws, and locking covers) to create the TruProfile Interbody configuration. The fixation implants are manufactured from titanium alloy (Ti-6A1-4V ELI per ASTM F136) and provided non-sterile. The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components. Explorer TO System: The Explorer TO System is a lumbar intervertebral body fusion device used to act as a disc spacer and hold bone graft to promote fusion in the lumbar spine. The system consists of non-sterile implants manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136). The system is comprised of height expandable and lordotic expandable interbody spacers, and both configurations are available in a range of lengths, widths, heights, and lordotic angles. The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as travs and caddies that mav be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components. WaveForm C Interbody System: The WaveForm C Interbody System consists of anterior cervical intervertebral body fusion devices additively manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The interbody spacers are offered in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy. The spacers, which include a central graft window for receiving autogenous bone graft and/or allogenic bone graft material, are individually packaged and gamma sterilized. The WaveForm C Interbody System can be used with supplemental fixation, such as an anterior plate, or as a standalone construct in combination with the Shoreline ACS Interbody System non-sterile fixation implants (i.e., plates, bone screws, and locking covers) to create the TruProfile and No-profile configurations. The fixation implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136). The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components. WaveForm TO Interbody System: The WaveForm TO Interbody System consists of posterior lumbar intervertebral body fusion devices additively manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The straight, rectangular-shaped interbody spacers are available in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy and include a central graft window for receiving autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The spacers are individually packaged and gamma sterilized. The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components. WaveForm TA Interbody System: The WaveForm TA Interbody System consists of posterior lumbar intervertebral body fusion devices additively manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The curved, banana-shaped interbody spacers are available in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy and include a central graft window for receiving autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The spacers are individually packaged and gamma sterilized. The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components. FORZA XP Expandable Spacer System: The FORZA XP Expandable Spacer System is comprised of an assortment of single-use spacers made from titanium alloy and PEEK polymer with height expansion capability. The implants feature a bulleted nose for ease of insertion and anti-migration ripples on both the inferior and superior surfaces to provide increased stability and help prevent anterior/posterior movement of the device. FORZA XP spacers are provided in both sterile and non-sterile configurations. The implants are offered in non-lordotic, lordotic, and hyperlordotic configurations to help restore the natural curvature of the spine. The implants can be used in single placement or pairs with typical approaches being transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF). The FORZA XP Expandable Spacer System is not intended to be used as a stand-alone device and must be used with a supplemental fixation system. Shoreline ACS Interbody System: The Shoreline ACS Interbody System featuring NanoMetalene® surface technology consists of anterior cervical intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026) with tantalum (per ASTM F560) and/or titanium alloy (Ti-6Al-4V ELI per ASTM F136) markers for radiographic visualization and NanoMetalene, which is a onemicron thick surface layer of commercially pure titanium (per ASTM F67) that provides a microscopic roughened surface with nano-scale features. The interbody spacers are offered in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy. The spacers, which include a central graft window for receiving autogenous bone graft and/or allogenic bone graft material or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation, are individually packaged and gamma sterilized. The Shoreline ACS Interbody System can be used with supplemental fixation, such as an anterior plate, or as a standalone construct in combination with non-sterile fixation implants (i.e., plates, bone screws, and locking covers) to create the TruProfile configurations. The fixation implants are manufactured from titanium allov (Ti-6Al-4V ELI per ASTM F136). The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as travs and caddies that mav be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components. Shoreline RT Interbody System: The Shoreline RT Interbody System featuring NanoMetalene® surface technology consists of anterior cervical intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026) with tantalum (per ASTM F560) and/or titanium alloy (Ti-6A1-4V ELI per ASTM F136) markers for radiographic visualization and NanoMetalene, which is a onemicron thick surface layer of commercially pure titanium (per ASTM F67) that provides a microscopic roughened surface with nano-scale features. The interbody spacers are offered in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy. The spacers, which include a central graft window for receiving autogenous bone graft and/or allogenic bone graft material or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation, are individually packaged and gamma sterilized. The Shoreline RT Interbody System can be used with supplemental fixation, such as an anterior plate, or as a standalone construct in combination with the Shoreline ACS Interbody System nonsterile fixation implants (i.e., plates, bone screws, and locking covers) to create the TruProfile configuration. The fixation implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136). The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components. Meridian Interbody System: The Meridian Interbody System featuring NanoMetalene® surface technology consists of anterior lumbar intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026) with tantalum (per ASTM F560) and titanium alloy (Ti-6Al-4V ELI per ASTM F136) markers for radiographic visualization and NanoMetalene, which is a one-micron thick surface layer of commercially pure titanium (per ASTM F67). NanoMetalene surface technology provides a microscopic roughened surface with nano-scale features. The interbody spacers are available in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy and include a central graft window for receiving autogenous and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation. The spacers are individually packaged and gamma sterilized. The Meridian Interbody System spacers can be used alone with supplemental fixation or in combination with fixation implants to create the TruProfile and No-profile Interbody configurations. Fixation implants include Anterior Plates, Screws, Inline Fixation Anchors, Anterior Plate Locking Covers, and No-profile Locking Covers, all of which are manufactured from titanium alloy (Ti-6A1-4V ELI per ASTM F136) and provided non-sterile. The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as travs and caddies that mav be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components. WaveForm A Interbody System: The WaveForm A Interbody System consists of anterior lumbar intervertebral body fusion devices additively manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The interbody spacers are offered in a variety of footprints. heights, and lordotic options to accommodate variations in pathology and patient anatomy as well as with and without a sodium hydroxide (NaOH) surface treatment that provides a microscopic, roughened surface with nanoscale features. The interbody spacers, which include a central graft window for receiving autogenous and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation, are individually packaged and gamma sterilized. The WaveForm A Interbody System spacers can be used alone with supplemental fixation or in combination with fixation implants to create the TruProfile and No-profile Interbody configurations. Fixation implants include Anterior Plates, Screws, Inline Fixation Anchors, Anterior Plate Locking Covers, and No-profile Locking Covers, all of which are manufactured from titanium alloy (Ti-6A1-4V ELI per ASTM F136) and provided non-sterile. The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

FITBONE® Trochanteric is indicated for limb lengthening of the femur. FITBONE® Trochanteric is indicated for adult and pediatric (greater than 12 through 21 years of age) patients.

The FITBONE® Trochanteric is a fully implantable intramedullary lengthening nail and accessories. The subject FITBONE® Trochanteric consists of the implantable intramedullary lengthening nail and accessories (Locking screws, Trial nails, K-wire and Convenience kits). The Subject device is implanted into the medullary canal of the femur and connected to the primary predicate intracutaneous Receiver (K163368) by a bipolar feed line. The external FITBONE Control Set is the same as previously cleared for the primary predicate Fitbone TAA device (K203399) and consists of a control electronics station and transmitter. There are no changes to the previously cleared Control Sets and Receiver as a result of this submission. The power required for the distraction process is controlled by hermetically enclosed motor which draws the telescope apart. The electro-magnetic field sent from the Transmitter to the Receiver is converted in the Receiver into DC-Voltage to supply the motor of the subject Fitbone Trochanteric Nails with voltage, when actioned. The subject Fitbone Trochanteric Nails are available in two different diameter models (D09mm, D11mm), different lengths and lengthening capabilities. The subject nail is anchored to the bone by subject locking screws. The locking screws are available in two variants (standard locking screws and revision locking screws), in two diameters, D4.5mm and D4mm, and in multiple lengths. The energy needed for the distraction process is transmitted from the outside by placing the external transmitter over the implanted receiver, which is placed in the subcutaneous tissue during surgery. There is no transcutaneous contact between the implanted intramedullary nail and the outer surface of the patient's body. The subject trial nails accessories are available for each variant of the Fitbone Trochanteric nails and are used to simulate the shape of the implant. The subject Fitbone Trochanteric nail and K-wire are provided in sterile conditions only. The trial nails are provided in non-sterile version only. The bone screws are available in both sterile and non-sterile versions. The subject Fitbone Trochanteric Nails and their accessories are made from, as follows: Nail: implant grade stainless steel 1.4441, according to ASTM F138-13 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)", and Silicone Nusilmed (NuSil MED-4870, NuSil MED-1511, Nusil MED 4750, NUSIL MED1-161, NUSIL MED2-4502). Trial nail: implant grade stainless steel 1.4441, according to ASTM F138-13 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)" and ASTM F899-20 Standard Specification for Wrought Stainless Steels for Surgical Instruments. Locking screws: implant grade stainless steel 1.4441, according to ASTM F138-13 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)" K-wire: implant grade stainless steel 1.4441, according to ASTM F138-13 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)" The Subject, as the primary predicate, will be implanted only by Healthcare Professionals (HCP), with full awareness of the appropriate orthopedic procedures

The PILLAR SA Ti Spacer System when used with screws is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The The PILLAR SA Ti Interbody may be used as a standalone device only when at least two Screws are inserted with one inferior and one superior screw trajectory. If the surgeon chooses to use the PILLAR SA Ti Interbody with fewer than two Screws inserted with one inferior and one superior screw trajectory, then additional supplemental fixation system must be used. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.

The PILLAR SA Ti Spacer System is an integrated in ody fusion device for use in anterior lumbar interbody fusion (ALIF) procedures. The PILLAR SA TI Spacer System is compised of 3D printed titanium interbody spacers with porous titanium end plates and a functional gradient porous structure, and bone screws. The implants are offered in multiple footprints and lordotic options to accommodate individual patient anatomy. Each porous interbody has a large central window for graft material and a threaded hole with a zero-step locking mechanism for screw retention. The PILLAR SA TI Spacer System implants are provided sterile. PILLAR SA TI Spacer System implants are designed to be used with PILLAR SA TI Spacer System instrumentation and are not compatible with components from any other manufacturer's system.

The RODEO Telescopic Nail is indicated for fractures, osteotomies, malunions and non-unions in femur and tibia in pediatric patients suffering from osteogenesis imperfecta.

The subject RODEO™ Telescopic Nail is a self-extending rod intended to provide bone fixation. The nail includes the telescopic rod, which consists of two parts (male and female) and bone anchors, which could be either a cap or an epiphyseal screw suitable to the anatomical application. The nail is provided in sterile and non-sterile version and is available in five diameters (3.5mm, 4.0mm, 4.5mm, 5.0mm and 6.0mm), identified by the outer diameter of the female part of the rod, and five lengths for each diameter model (from 100 mm up to 350 mm). Application and removal are performed with Orthofix general orthopedic instrumentation. The subject RODEO™ Telescopic Nail consists of three different components which are intended to be assembled to form the implant: Male component - A solid shaft with a built-in bone anchor for bone connection; the bone anchor has the same design as the cap (described below). Female component - A hollow shaft designed to host the male component. Bone anchors - Two options are available depending on the desired application: Cap - A self-locking screw to be connected with the female component at the opposite aspect of the extremity relative to the male component. Epiphyseal Pin - A threaded pin to be inserted into the distal extremity hole to hold the female component in position and prevent migration (see Figure 3) When the male and female components are assembled, the resulting implant is a telescopic rod. Male and female components are free to move both axially and rotationally; this allows the nail to extend axially as the patient growth occurs while allowing rotation around the bone anchors. The subject implants are made from AISI 316LVM stainless steel, conforming to ASTM F138 and ISO 5832-1.

"FITBONE Transport and Lengthening system" is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, malunions, non-unions, or bone transport of the long bones. The "FITBONE Transport and Lengthening system" is indicated for adult only.

The subject “FITBONE® Transport and Lengthening System” consists of the implantable intramedullary transport or lengthening nail and its trial nail accessories. The Subject device is implanted into the medullary canal of the femur or tibia and connected to the additional predicate intracutaneous Receiver by a bipolar feed line. The external FITBONE Control Set is identical to that previously cleared for the additional predicate Fitbone TAA device (K203399) and consists of a control electronics station and transmitter. There are no changes to this previously cleared Control Sets and Receiver as a result of this submission. The power required for the distraction process is controlled by hermetically enclosed motor which draws the telescope apart. The electro-magnetic field sent from the Transmitter to the Receiver is converted in the Receiver into DC-Voltage to supply the motor of the FITBONE Transport and Lengthening Nail with voltage, when actioned. The subject nail is anchored to the bone by locking screws through medial-lateral and AP holes in the nail depending on the configuration holes in the nail. The energy needed for the distraction process is transmitted from the outside by placing the external transmitter over the implanted receiver, which is placed in the subcutaneous tissue during surgery. There is no transcutaneous contact between the implanted intramedullary nail and the outer surface of the patient's body. The subject trial nails accessories are available for each size model of the FITBONE Transport (TN) and FITBONE Transport or Lengthening (TLN) nails and are used to simulate the shape of the implant. The subject nails and trial nails are provided in sterile conditions only and are made from, as follows: • Nail: implant grade stainless steel 1.4441, according to ASTM F138- 13 "Standard Specification for Wrought 18Chromium-14Nickel- 2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)", and Silicone Nusilmed (NuSil MED-4870, NuSil MED- 1511, Nusil MED 4750). • Trial nail: implant grade stainless steel 1.4441, according to ASTM F138-13 "Standard Specification for Wrought 18Chromium-14Nickel- 2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)" and ASTM F899-20 Standard Specification for Wrought Stainless Steels for Surgical Instruments For the implantation and removal of the subject device the same instruments of the additional predicate Fitbone TAA (K203399) may be used.

The OFIX MIS App software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The app allows service providers to plan surgical procedures by making measurements for the placement of surgical implants. Clinical judgement and experience are required to properly use the software.

The OFIX MIS App will provide a novel mobile phone solution to supplement the use of calipers when selecting rods used in immobilization of pedicle screw type spinal systems. The App will rely on capturing 2D images used in spinal implant procedures through use of mobile phone camera. The App measures the difference between known Orthofix pedicle screw diameters and provides feedback useful in determining appropriate rod length with corresponding Orthofix product number.