PRODUCT CATALOG SPINE

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1 SPINE 08/09 PRODUCT CATALOG SPINE

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3 GMReis Quality for Life - this is GMReis business vision, a company that, since 989, has been: developing, producing and marketing its product line, classified in the following categories: Ÿ Spine; Ÿ Locking plates and cannulated screws, for traumatology of: upper limb, lower limb and pelvis ; Ÿ Intramedullary nails for traumatology of: upper and lower limbs, and ankle arthrodesis; Ÿ External fixators for traumatology and limb resconstruction; Ÿ Extremities: foot and hand; Ÿ Orthopediatrics; Ÿ Bioresorbable suture anchors and, Ÿ Biologics. GMReis constantly pursues technological innovations and quality products in order to meet customers, surgeons and patients expectations and needs. GMReis is located in Campinas/São Paulo Brazil, with an area of m², in a modern Technology Park. It has high-tech equipments, for quality control and production, an ISO Class 8 Cleanning Room of 600 square meters, where bone graft, spine PEEK cages and bioreabsorbable implants are manufactured.

4 INDEX PEEK CERVICAL SPACERS Atrium C-Lock PEEK Atrium C-PEEK ANTERIOR CERVICAL PLATING SYSTEM Sophira Plates OCCIPITOCERVICAL FIXATION OCCIFIX II - Occipitocervical Fixation System CORPECTOMY SPACERS ROM Mesh - Vertebral Spacer THORACIC, LUMBAR AND SACRAL FIXATION - POSTERIOR APPROACH EXACTO - Pedicular Internal Fixation System With Polyaxial Schanz Pins Pedimax II - Polyaxial Pedicle Screws System Percutaneous Spondylolisthesis Porous PEEK LUMBAR SPACERS Plifix PEEK - Posterior Lumbar Interbody Fusion Spacer Tlifix PEEK - Transforaminal Lumbar Interbody Fusion Spacer INTERSPINOUS SPACER Dynafix PEEK - Interspinous Spacer SPINE CABLE Gama Cable KYPHOPLASTY Restore Set VERTEBROPLASTY BPS-A Set BPS-P Set BIOLOGICALS Sponjosa - Beta-Tricalcium Phosphate (â-tcp) Synthetic Bone Graft New Osteo - Calcium Sulfate Synthetic Bone Graft Cimentech - Radiopaque Bone Cement

5 PEEK CERVICAL SPACERS Atrium C-Lock PEEK PEEK cervical intervertebral spacer with anti-migration locking system and anatomical shape Atrium C-Lock PEEK was developed for discectomy and arthrodesys anterior approach procedures, up to levels, to restore intervertebral height and support axial weight on treated level, with no need of plates and screws. 6 mm (small) mm (medium) mm (large) h 6 Anatomical design to fit perfectly on the intervertebral space and having maximum contact between the implant and the vertebral surface; Wide central canal for bone graft; "Toothed" surfaces increases implant fixation; The titanium identification pin allows to assess the exact positioning of the implant by x-ray visualization; Arrow Sign for positioning orientation from caudal to cranial spine region prevents placement mistakes and, The titanium alloy locking system, offers immediate stability and prevents the implant from shifting after placement without any plates and screws, reducing surgery time. Made of PEEK conform ASTMF06 COD 6--P 6-0-P 6-60-P 6-70-P 6--M 6-0-M 6-60-M 6-70-M 6--G 6-0-G 6-60-G 6-70-G Atrium C-Lock PEEK Small, mm Small,0 mm Small 6,0 mm Small 7,0 mm Medium, mm Medium,0 mm Medium 6,0 mm Medium 7,0 mm Locking system for Atrium C-Lock PEEK 6-0 h Large, mm Large,0 mm Large 6,0 mm Large 7,0 mm GMReis 0

6 PEEK CERVICAL SPACERS ATRIUM C-PEEK PEEK cervical intervertebral spacer with anatomical shape Atrium C-PEEK was developed for discectomy and arthrodesis for anterior procedures to restore intervertebral height and support axial weight on treated level. Made of PEEK conform ASTMF06 h Anatomical design to fit perfectly on the intervertebral space and better contact between the implant and the vertebral surface; Wide central canal for bone graft; "Toothed" surfaces increases implant fixation and, The titanium identification pins allow to assess the exact positioning of the implant by x-ray visualization. Atrium C-PEEK COD h 7--P,7 mm 7--P,7 mm 7-6-P 6,7 mm 7-7-P 7,7 mm 7-8-P 8,7 mm 7-9-P 9,7 mm PEEK PEEK (polyether ether ketone) is a thermoplastic material, biocompatible due to the combination of its chemical and mechanical properties: this material has higher chemical stability and mechanical properties similarly to the cancellous bone, when compared to steel or titanium alloy. The use of PEEK as raw material for surgical implants brings the advantage of its radiolucency, what allows to observe the intervertebral fusion on x-ray images. 0 GMReis

7 ANTERIOR CERVICAL PLATING SYSTEM Sophira Plates Low Profile Anterior Cervical Plate with locking system Sophira Plate was developed to treat of cervical spine pathologies by single or multi-level arthrodesis, improving the intervertebral fusion process. Placa Cervical Sophira Anterior Plates Sophira , mm 0 Holes,0 mm 0 Holes 7, mm 0 Holes 0,0 mm 0 Holes, mm 0 Holes 7, mm 0 Holes 0,0 mm 0 Holes, mm 0 Holes,0 mm 0 Holes 7, mm 0 Holes, mm 06 Holes 7, mm 07 Holes 6, mm 07 Holes 67, mm 07 Holes Placa Cervical Sophira Anterior Screws Sophira 9-6 Ø, x mm 9-7 Ø, x mm 9-8 Ø, x 7 mm 9-9 Ø,0 x mm 9-0 Ø,0 x mm 9- Ø,0 x 7 mm Low-profile (.7 mm) anatomic design for perfect adjust to the vertebra curvature and minimizes risks of soft tissue irritation; In-plate locking system provides safety for patient and prevent screws migration; Holes for temporary fixation facilitate the procedure, reducing surgical time and, Ø. and Ø.0 mm (emergency) Screws, with.0,.0 and 7.0 mm length. Made of titanium alloy (ti-6al-v) conform ASTMF6 GMReis 0

8 OCCIPITOCERVICAL FIXATION OCCIFIX II Occipitocervical Fixation System for cervical posterior fixation OCCIFIX II was developed for posterior fixation of the cervical spine, from occipital to high thoracic spine (T), with a variety of treatment possibilities Three different options for occipital fixation: rod/plate (a); and holes plates (b), and central plates (c); Ø, mm longitudinal rods (a), and long rods with dual diameter for cervicothoracic fixation (b); Lamina hooks with three size options, left and right; Connectors with three angulation options (neutral, º and º), allow laterality and convergence ajustment of the lateral mass screws; Polyaxial screws for lateral mass (a) and cancellous screws (b) which can be implanted on lateral mass or in the occipital; Lateral connector allows transverse extension for longitudinal rod; The same locking cap used for all system components and, Crosslink hooks enhances fixation rigidity and biomechanical stability. Made of titanium alloy (ti-6al-v) conform ASTMF6.a.b.b Occifix II Ø. Polyaxial Micro Screws -0- mm -0- mm mm mm -0- mm mm mm -0- mm mm -0- mm mm Occifix II Ø.0 Polyaxial Screw -0- mm -0- mm mm mm mm -0- mm -0- mm mm mm mm -0- mm -0- mm mm mm mm -0- mm mm Ø. Longitudinal Rod - 60 mm - 70 mm - 80 mm - 0 mm - 0 mm mm Rod -86 Ø. / Ø. x 00 mm -87 Ø. / Ø. x 00 mm -88 Ø. / Ø6.0 x 00 mm -89 Ø. / Ø6.0 x 00 mm Locking Cap -80 Occifix II Hook - Right Large - Left Large - Right Medium - Left Medium -09 Right Small -0 Left Small Occifix II Lateral Connector -0 0 mm -0 0 mm Occifix II Connectors -0 Neutral -0 Right Anguled -0 Left Anguled -0 Right Anguled -0 Left Anguled Occifix II Ø. Cancellous Screw mm mm mm -- mm -- mm mm mm mm -- mm mm -- mm mm Occifix Rod/Plate L Holes Holes Long Holes Holes Long Holes Holes Long 06 GMReis

9 Occifix II Occipital Plate -0-S -0-D Hole Holes Occifix II Occipital Central Plate -0-0-M Holes 0 mm M Holes 60 mm.c -0-0-L L Holes 0 mm Holes 60 mm Occifix II Occiptal Screws for Central Plate Ø. x mm Ø. x 6 mm Ø. x 8 mm Ø. x 0 mm Ø. x mm Ø. x mm Ø. x 6 mm Ø. x 8 mm Ø.0 x mm Ø.0 x 6 mm Ø.0 x 8 mm Ø.0 x 0 mm Ø.0 x mm Ø.0 x mm Ø.0 x 6 mm Ø.0 x 8 mm Occifix II Crosslink Hook Ø. Transversal Rod Made of titanium alloy (ti-6al-v) conform ASTMF6 7.a.a.b mm 0 mm 60 mm 70 mm 8 OCCIFIX Rod Connector mm Left.-. mm Right OCCIFIX Rod/Rod Connector mm Left mm Right Left Right.b GMReis 07

10 CORPECTOMY SPACERS ROM Mesh Titanium vertebral spacer developed for cervical, thoracic and lumbar corpectomy procedures ROM Mesh was developed to be used in corpectomy procedures on cervical, thoracic and lumbar spine levels to replace and to restore the height of a collapsed vertebral body. ROM Mesh is indicated for the treatment of infection, tumor and comminuted fractures. Placa Cervical ROM Anterior Mesh Sophira Four diameter options to fit on cervical, thoracic or lumbar spine; Two length options and the possibility to shorten the spacer height in according to each patient needs, by cutting the desired size; ROM Rings are placed on the spacer extremities to increase biomechanical resistance and reduce risks of implant insertion into the vertebral surfaces; 9--0-A A A A A A 9--0-A A Ø x 0 mm Ø x 60 mm Ø6 x 0 mm Ø6 x 70 mm Ø9 x 0 mm Ø9 x 70 mm Ø x 0 mm Ø x 70 mm The 8º lordosis ROM Ring is used with Ø mm spacer to adapt the implant to the curvature of the lumbar spine and, Large space for bone graft to promote intervertebral fusion. ROM Ring A Ø6 x 6 mm A Ø9 x 0 mm 9--0-A Ø x 0 mm A Ø mm 8º Lordosis ROM Ring Screws GMReis Made of titanium alloy (ti-6al-v) conform ASTMF6

11 THORACIC, LUMBAR AND SACRAL FIXATION - POSTERIOR APPROACH EXACTO Pedicular Internal Fixation System With Polyaxial Schanz Pins EXACTO fixation system was developed for treatment of pathologies of thoracic, lumbar and sacral spine. EXACTO is specifically indicated for procedures of fracture and spondylolisthesis correction. Made of titanium alloy (ti-6al-v) conform ASTMF6 Crosslink Hook Pedimax II - Exacto Connectors Standard Sacral Pedicular Pins Ø.0 mm Ø6. mm Ø7.0 mm The Schanz Pins fixation system allows using the pins upper extension to fracture reduction; The polyaxial connectors facilitates the system setting-up and helps to restore the anatomy of fractured vertebra and treated segment; Spondylo Pedicular Pins Ø.0 mm Ø6. mm Ø7.0 mm Placa Cervical Ø6.0 mm Anterior Rod Sophira The Spondylo Pedicle Pins allow spondylolisthesis correction; Connectors developed for using in the caudal extremity of the rods in sacral spine fixation; mm 70 mm 90 mm GMReis 08 0 mm 0 mm 0 mm 6 The Crosslink hook increases fixation hardness and biomechanical stability and, After the final locking, the pins are cutted off to reduce the system profile. Ø. mm Transversal Rod -6 Ø. x 60 mm -7 Ø. x 80 mm GMReis 09

12 THORACIC, LUMBAR AND SACRAL FIXATION - POSTERIOR APPROACH PEDIMAX II Titanium Pedicle Screws System for thoracic, lumbar and sacral spine posterior arthrodesis PEDIMAX II was developed for thoracic, lumbar and sacral spine posterior arthrodesis, for treating spinal pathologies: disc degenerative diseases, spondylolisthesis, trauma, tumor, stenosis, pseudarthrosis and deformities. PEDIMAX II Percutaneous Cannulated Pedicle Polyaxial Screws for minimally invasive technique PEDIMAX II Spondylolisthesis Pedicle Polyaxial Screws with extended tabs for spondylolisthesis reduction 6 PEDIMAX II POROUS Cannulated and perforated pedicle screw for bone cement injection. This product is indicated in cases of augmentation procedure in osteoporotic patients treatment Porous Pedicle Screw for osteoporotic bone 7 Syringe with Cimentech bone cement Porous cement delivery device 0 GMReis GMReis indicates Cimentech bone cement (page 7) to be used with Porous*. *Product sold separately. Made of titanium alloy (ti-6al-v) conform ASTMF6

13 The set comes with polyaxial and monoaxial screws with different diameters and lengths to supply any surgical needs; Porous - Single Use Cement Delivery Device Ø6.0 Percutaneous Rod 0.0 mm.0 mm 80.0 mm 90.0 mm 6 7 Internal locking cap provides higher stability to system fixation; Self-tapping screws that reduce surgery time; The Crosslink hook increases fixation hardness and biomechanical stability; Cannulated polyaxial screws for percutaneous implantation; Polyaxial screws with extended tabs, solid shaft and cannulated, for spondylolisthesis reduction and, Polyaxial screws, cannulated with distal hole shaft and delivery device to bone cement augmentation for treatment of osteoporotic patients. Pedimax II Crosslink Hook Pedimax II Percutaneous Polyaxial Pedicle Screw Ø. x 0 mm Ø. x mm Ø. x 0 mm Ø. x mm Ø6. x mm Ø6. x 0 mm Ø6. x mm Ø6. x 0 mm Ø7.0 x 0 mm Ø7.0 x mm Ø7.0 x 0 mm Ø7.0 x mm Ø7.0 x 0 mm Pedimax II Locking Cap 76-0 Pedimax II Spondylolisthesis Polyaxial Pedicle Screw Ø. x 0 mm Ø. x mm Ø. x 0 mm Ø. x mm Ø. x 0 mm Ø6. x mm Ø6. x 0 mm Ø6. x mm Ø6. x 0 mm Ø7.0 x 0 mm Ø7.0 x mm Ø7.0 x 0 mm Ø7.0 x mm Ø7.0 x 0 mm Pedimax II Monoaxial Pedicle Screw Ø. x 0 mm Ø. x mm Ø. x 0 mm Ø. x mm Ø. x 0 mm Ø6. x 0 mm Ø6. x mm Ø6. x 0 mm Ø6. x mm Ø6. x 0 mm Ø6. x mm Ø6. x 60 mm Ø7.0 x 0 mm Ø7.0 x mm Ø7.0 x 0 mm Ø7.0 x mm Ø7.0 x 0 mm Ø7.0 x mm Ø7.0 x 60 mm Ø8.0 x 0 mm Ø8.0 x mm Pedimax II Polyaxial Pedicle Screw Ø. x 0 mm Ø. x mm Ø. x 0 mm Ø. x mm Ø. x 0 mm Ø. x mm Ø. x 0 mm Ø. x mm Ø. x 0 mm Ø. x mm Ø. x 0 mm Ø. x mm Ø. x 60 mm Ø6. x 0 mm Ø6. x mm Ø6. x 0 mm Ø6. x mm Ø6. x 0 mm Ø6. x mm Ø6. x 60 mm Ø7.0 x 0 mm Ø7.0 x mm Ø7.0 x 0 mm Ø7.0 x mm Ø7.0 x 0 mm Ø7.0 x mm Ø7.0 x 60 mm Ø. Transversal Rod 60.0 mm 80.0 mm 00.0 mm Pedimax II Spondylolisthesis Percutaneous Polyaxial Pedicle Screw --0-E ---E --0-E ---E -6--E -6-0-E -6--E -6-0-E E -70--E E -70--E E Ø. x 0 mm Ø. x mm Ø. x 0 mm Ø. x mm Ø6. x mm Ø6. x 0 mm Ø6. x mm Ø6. x 0 mm Ø7.0 x 0 mm Ø7.0 x mm Ø7.0 x 0 mm Ø7.0 x mm Ø7.0 x 0 mm Pedimax II Porous Polyaxial Pedicle Screw E D Ø. x 0 mm Ø. x mm Ø. x 0 mm Ø. x mm Ø. x 0 mm Ø. x mm Ø. x 60 mm Ø6. x mm Ø6. x 0 mm Ø6. x mm Ø6. x 0 mm Ø7.0 x 0 mm Ø7.0 x mm Ø7.0 x 0 mm Ø6.0 Longitudinal Rod 0.0 mm 0.0 mm 60.0 mm 70.0 mm 80.0 mm 90.0 mm 00.0 mm 0.0 mm 0.0 mm 0.0 mm 80.0 mm 0.0 mm 80.0 mm 0.0 mm Rod/Rod Connector Ø. / 6.0 mm Left Ø. / 6.0 mm Right Ø6.0 /. mm Left Ø6.0 /. mm Right Ø6.0 / 6.0 mm Left Ø6.0 / 6.0 mm Right GMReis

14 PEEK LUMBAR INTERBODY SPACERS PLIFIX PEEK Posterior Lumbar Interbody Fusion Spacer "Toothed" surfaces provide resistance to implant migration; The titanium markers allow to assess the exact positioning of the implant by x-ray visualization; Wide central canal for bone graft; The set comes with seven implants height options to allow a better adaptation on patient anatomy and, Implantation by posterior approach. Plifix PEEK COD 79-0P 79-0P 79-0P 79-0P 79-0P 79-06P 79-07P h 9 mm 0 mm mm mm mm mm mm h The Plifix PEEK and Tlifix PEEK spacers were developed for discectomy and lumbar fusion on spine, to restore intervertebral height and support axial weight on treated level. TLIFIX PEEK Transforaminal Lumbar Interbody Fusion Spacer Made of PEEK conform ASTMF06 6 "Toothed" surfaces provide resistance to implant migration; The titanium markers allow to assess the exact implant positioning, by x-ray visualization; Wide central canals for bone graft; The set comes with six implants height options to allow a better adaptation on patient anatomy; COD 87-0P 87-0P Tlifix PEEK h 08 mm 09 mm h 6 Bullet nose for an easier implant insertion; Anatomical curvature and lordotic angulation to fit perfectly on the intervertebral space and having maximum contact between the implant and the vertebral surface and, 87-0P 87-0P 0 mm mm 7 Implantation by transforaminal approach. 87-0P mm 87-06P mm GMReis

15 INTERSPINOUS SPACER DYNAFIX PEEK PEEK Interspinous Space Spacer/Plate Dynafix PEEK was developed for lumbosacral spine stabilization/ decompression procedures, to restore and maintain its biomechanical properties. The device is placed in interspinous space, partially restrincting mobility on treated level and reducing tension on posterior joints. Made of PEEK conform ASTMF06 h The interspinous spacer extends the segmental extension on intervertebral foramen, treating radicular spinal stenosis; The set comes with four size options and the spacer has anatomical shape to allow better placement on interspinous process; Dynafix PEEK COD h 6-07-P 08 mm 6-0-P 0 mm 6-0-P mm 6-0-P mm The lateral wings are used for spacer fixation on spinous process, implant is designed to allow multilevel fixation; Placa Gama Cervical Cable Anterior Ø. Sophira mm The implants shape and raw matter provide physiological alike elasticity, improves implant flexibility, weight distribution and impact absorption and, 0-0 The titanium identification pin allows to assess the exact positioning of the implant by x-ray visualization. GAMA CABLE Titanium microfilament cerclage wire Gama Cable is indicated to fix Dynafix PEEK Interbody Spacer in the spinous process; The end of the cable (00 mm) is solid and can be shaped for easier cerclage; Gama Cable is 0 mm length, has high resistance and excellent biocompatibility and, GMReis Gama Cable set has its own instrumental devices for tensioning, locking and cuting off the cable excess. Made of titanium alloy (ti-6al-v) conform ASTMF6 GMReis

16 KYPHOPLASTY RESTORE SET Sterile instrumental set for kyphoplasty procedures RESTORE is a minimally invasive procedure designed to repair vertebral compression fractures, normally caused by osteoporosis or tumor. RESTORE utilizes orthopedic balloons for anatomical reduction of fractured vertebra, restoring vertebral body height and correcting angular deformity; The cavities formed by the balloons, allow a safe and controlled filling of bone cement, under low-pressure, and in pre-defined quantity, reduce risk of leakage; The balloons resist up to 00 psi on first use, and the pressure growth can be monitored on a digital display; The balloons come in three length options: 0, and 0 mm and, Full instrumental set for simultaneous (bilateral) kyphoplasty with two balloons, through the fractured vertebra pedicles. Restore Set CIF-0RET 0 mm CIF-RET mm CIF-0RET 0 mm GMReis GMReis indicates Cimentech bone cement (page 7) to be used with the Restore Set*. *Product sold separately.

17 ml ml VERTEBROPLASTY BPS-A SET Sterile instrumental set for vertebroplasty procedures, with parapedicular (vertebral body) approach 0 0 Vertebroplasty procedures consist in a percutaneous injection of bone cement into the vertebral body for treating fractures caused by: osteoporosis, tumor and trauma. Simple, safe and efficient instrumental set that comes with two approach options: transpedicular and parapedicular (vertebral body); for adequating the procedure and the surgical planning to the fracture specifications; The larger diameter cannula from BPS-A set allows to make bone biopsy and, The BPS-P set, with transpedicular approach, can be used to inject bone cement into osteoporotic vertebrae in order to enhance fixation with pedicular screws. Percutaneous Single-Use Set BPS-P SET -0-0 BPS-A Set BPS-P Set Sterile instrumental set for vertebroplasty procedures, with transpedicular approach 0 0 GMReis indicates Cimentech bone cement (page 7) to be used with BPS-A and BPS-P. *Product sold separately. GMReis

18 BIOLOGICALS Sponjosa Synthetic bone graft made of beta-tricalcium phosphate (ß-TCP) Biactive, biocompatible, biodegradable, radiopaque, osteoconductive and bioresorbable. Sponjosa is indicated to fulfill bone cavities or bone deformities caused by trauma or surgical intervention. ANVISA/MS: Sponjosa Grain 0 cc Grain 0 cc Cunha 7 mm Cunha 0 mm Cunha mm Scanning Electron Microscopy: 0x Cancellous bone structure Sponjosa structure New Osteo Synthetic bone graft made of calcium sulfate. Non-toxic, biocompatible, biodegradable, radiopaque, osteoconductive and bioresorbable. ANVISA/MS: INFECTION TREATMENT New Osteo s á - hemihydrate crystalline structure New Osteo can be used with antibiotics to control and prevent local osteomyelitis New Osteo Dust cc Dust 0 cc Dust 0 cc Grain cc Grain 0 cc Grain 0 cc New Osteo New Osteo + Antibiotic Infected Bone tissue Antibiotic 6 GMReis Controlled liberation

19 Cimentech Polymerizable radiopaque bone cement, non-resorbable, made of acrylic compounds and consisting of a liquid component (methyl methacrylate - MMA) and a powder component (Polymethyl Methacrylate PMMA + Barium Sulfate BaSO ). X-Ray Cimentech is indicated for these procedures: vertebroplasty, kyphoplasty and as an anchor for restoring mechanical conditions in osteoporotic bones, using a specific implant. Radiopacity Another bone cement 0% Barium sulfate Cimentech 0% Barium sulfate Syringe with Cimentech bone cement Cimentech is developed in according to ABNT NBR ISO 8; Cimentech has initially low viscosity (what makes syringe charge easier), high intrusion (fundamental for its fixation on bone tissue) and higher radiopacity than other bone cements and, The bone cement polymerization occurs progressively between and minutes depending on the enviroment conditions. Porous Pedicle Screw for osteoporotic bone Cimentech GMReis

20 GMREIS Pierre Simon de Laplace Avenue, Lote Quadra F - Techno Park ZIP CODE: Campinas/SP - Brazil Phone: + (9) Export export@gmreis.com.br gmreis@gmreis.com.br GMReis.com.br Any information in this catalog can be changed at any moment. Please, check our website to verify them. GMReis, 08. All rights reserved. Spine Catalog JUL/08

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