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IB3D™ PL Spinal System is indicated for use in lumbar spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at 1 or 2 contiguous levels from L2 to S1. DDD is defined as discogenic back pain 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 levels. When used for these indications, the IB3D™ PL Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Additionally, the IB3D™ PL Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. All patients should be skeletally mature and have had at least 6 months of nonoperative treatment. The IB3D™ PL Spinal System is intended to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone marrow aspirate when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach. When implanting via posterior approach (PLIF), a minimum of two implants is required per spinal level.

The IB3D™ PL Spinal System implants are inter-somatic spacers manufactured by additive manufacturing (Direct Laser Metal Sintering) from Titanium alloy Ti-6Al-4V ELI powder, according to ASTM F3001 and ASTM F136. The IB3D™ PL Spinal System implants are intended for insertion between two adjacent vertebrae by a posterior or a transforaminal approach on the lumbar spine only. The subject IB3D™ PL Spinal System interbody devices are available in a variety of heights and lordosis angles for treatment of lumbar interbody fusion procedure. The implant is designed with a large hollow region in the center to house autograft or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone marrow aspirate. The design incorporates hexalock macro-rough surface on the superior and inferior surfaces of the device along with angular teeth to prevent expulsion from the interbody space.

MEDICREA® INTERNATIONAL UNiD® IB3D ALIF device is designed individually for each patient and indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I Spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft. UNID® IB3D ALIF device is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

The MEDICREA® INTERNATIONAL UNiD® IB3D ALIF device consists of one single implant with specific heights, footprint, lordosis and coronal angle. Patient matched endplates can be added to the implant. It is intended for insertion between two adjacent vertebrae by an anterior approach. The MEDICREA® INTERNATIONAL implant is manufactured from titanium alloy Ti-6AI-4V ELI following ASTM F3001 standard, a radio opaque material. As any orthopaedic implants should not be reused. For a complete quide of the system, please refer to the surgical technique manual for specific instructions. The UNiD® IB3D ALIF cage is designed for a specific patient, it must not be used for another patient. MATERIALS: Components are manufactured from Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001. Function: The UNiD® IB3D ALIF was developed as an implant: - to provide immobilization and stabilization of posterior spinal segments . - to augment the development of a solid spinal fusion ● - . to provide stability to ease fusion - to be mechanically resistant to allow the fusion of the operated level

MEDICREA® INTERNATIONAL IB3D ALIF device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I Spondylolisthesis or Retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. IB3D ALIF Device is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

MEDICREA® INTERNATIONAL IB3D ALIF device consists of one single implant available in several heights, lengths, lordosis and footprints. It is intended for insertion between two adjacent vertebrae by an anterior approach. The MEDICREA® INTERNATIONAL implant is manufactured from titanium alloy Ti-6Al-4V ELI following standards ASTM F3001, a radio opaque material. As any orthopaedic implant, the lumbar interbody device must not be reused. The surgeon should strictly follow the recommendations provided in the surgical technique.

UNiD Patient-matched PLIF cage is indicated for lumbar spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels form L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I Spondylolisthesis or Retrolisthesis at the involved level(s). This device is to be used with bone graff. UNiD Patient-matched PLIF cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The UNiD patient-matched PLIF cage is an intervertebral lumbar device, designed to match the anatomy of an individual patient from patient imaging data (X-Ray, MRI, CT). The implant is manufactured in titanium alloy (Ti-6Al-4V ELI conforming to ASTM F3001 specifications) from additive manufacturing process.

UNiD Patient specific 3D printed TLIF cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft. UNiD Patient specific 3D printed TLIF cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

MEDICREA® INTERNATIONAL UNiD Patient specific 3D Printed TLIF cage consists of one single implant with specific heights, length and lordosis angle to the patient. It is intended for insertion between two adjacent vertebrae by a posterior or a transforaminal approach. The MEDICREA® INTERNATIONAL implant is manufactured from titanium alloy Ti-6AI-4V ELI following standards ASTM F3001, a radio opaque material. As any orthopaedic implant, the lumbar interbody device must not be reused. The surgeon should strictly follow the recommendations provided in the surgical technique. MATERIALS: Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001. Function: The UNiD Patient specific 3D printed TLIF cage was developed as an implant: - To provide immobilization and stabilization of posterior spinal segments ● - to augment the development of a solid spinal fusion - to provide stability to ease fusion ● - to be mechanically resistant to allow the fusion of the operated level

The PASS LP Spinal System is a pedicle screw fixation system intended for immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion. Except for rod plates and caps for sacral plates, when used for posterior non-cervical pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to treat adolescent idiopathic scollosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis and fracture caused by tumor and/or trauma. The PASS LP Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PASS LP is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine. The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rods, nuts, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 and ISO 5832-3. A subset of PASS LP components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. The PASS LP components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case. The purpose of this submission is to extend to the PASS LP range, with the addition of those new components: - TULIP GENESIS Non-cannulated Pedicle Screws - TULIP GENESIS Non-cannulated Iliac Screws - TULIP GENESIS Cannulated Pedicle Screws - TULIP GENESIS Cannulated Iliac Screws - TULIP GENESIS Breakable Setscrew

The PASS LP Spinal System is a pedicle screw fixation system intended for immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion. Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatic patients diagnosed with the following conditions: spondylolistis and fracture caused by tumor and/or trauma. The PASS LP Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PASS LP is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine. The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rods, nuts, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 or cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537. A subset of PASS LP components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. The PASS LP components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case. The purpose of this submission is to extend to the PASS LP, with the addition of new components: 'Dominoes & Iliac Connectors'.

UNiD 3D printed interbody system device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft. UNiD 3D printed interbody system device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The UNiD 3D printed cage is an intervertebral lumbar device, which consists of various implant sizes to adapt the implant to the patient anatomy. The implants are manufactured in titanium alloy (Ti-6Al-4V ELI conforming to ASTM F3001 specifications) from additive manufacturing process.

The LigaPASS is a temporary implant 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, used in sublaminar, or facet wiring techniques -Spinal reconstruction 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 kyphosis; -Spinal degenerative surgery, as an adjunct to spinal fusions; The LigaPASS system may also be used in conjunction with other medical implants made of titanium or cobalt chrome alloy whenever "wiring" may help secure the attachment of other implants.

The LigaPASS System connects a rod to a vertebral body using a specific type of connector and a flexible band. This connector can independently tighten the rod and the bone anchor. It is comprised by a connector body, a rod set screw, a locking set screw for the band and a polyester band. The purpose of this submission is to introduce the LigaPASS 2.0 Band - B08110005 and the LigaPASS 2.0 Dual Band - B08110010. MATERIALS: Components in these bands are manufactured from pure titanium that conforms to ASTM F67 and biocompatible Polyethylene Terephthalate (PET). Function: The LigaPASS spinal system was developed as an implant: • To provide temporary stabilization as bone anchor during the development of solid bony fusion. • To aid the repair of bone fracture.

IMPIX 3D Print cages are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. IMPIX 3D Print cages are to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

The IMPIX 3D Print PLIF, IMPIX 3D Print TLIF, and IMPIX 3D Print TLIF-S are intervertebral lumbar devices, which consists of a variety of shapes and sizes. The implants are manufactured in titanium alloy (Ti-6Al-4V ELI conforming to ASTM F3001 specifications) from additive manufacturing process. MATERIALS: Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001. Function: The 3D printed Lumbar cage was developed as an implant: - · To provide immobilization and stabilization of anterior spinal segments - · to augment the development of a solid spinal fusion - · to provide stability to ease fusion - · to be mechanically resistant to allow the fusion of the operated level