EFSPINE CERVICAL COMBINED SET DISC PROTHESIS ORGANIZER BOX

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1 EFSPINE CERVICAL COMBINED SET INSTRUMENTS CERVICAL CAGE & DISC PROTHESIS ORGANIZER BOX

2 Cervical Thoracic Thoraco - Lumbar Sacral EFSPINE CERVICAL COMBINED SET

3 CERVICAL IMPLANTS

4 INTRODUCTION Cervical Disc Prothesis Efspine Cervical Disc Prostheses are designed to preserve motion, avoid limitations of fusion, and allow patients to return quickly to routine activities. The primary goals of these disc prostheses in the cervical spine are to restore disc height and segmental motion after removing local pathology that is deemed to be the source of a patient s index complaint and to preserve normal motion at adjacent cervical levels, which may be theorized to prevent later adjacent level degeneration. Cervical Expandable Cage For providing easy fixation to the cervical vertebra. Efspine cervical expandable cage have threaded surfaces and expand pin with expandig motion. Cervical Bladed Cage EFSPINE Cervical bladed peek cage has a unique design and is available in various heights to restore the interbody space. Cervical Expandable Bladed Cage Expandable cervical bladed peek cage is available in a variety of sizes to allow the surgeon to choose what is best suited to the patient s anatomy and pathology. Cervical Cage Efspine Cervical peek cage is designed to provide structural support as an interbody spacer for anterior cervical fusions.

5 CERVICAL DISC PROTHESIS Cervical Disc Prothesis 360 o EFSPINE Cervical Disc Prosthesis is a single use device for cervical intervertebral disc replacement at one level or two contiguous levels from C3 to C7 in order to maintain/restore segmental motion and disc height. Two different types of cervical disc prosthesis which are made of titanium and peek materials. Anodized and TIN coated surface options are available for the titanium type. CERVICAL TITANIUM DISC PROTHESIS Ti6AL4V-ELI pin material in the middle of the mechanism, provides a perfect motion capability. Special design for 360 O movement ability. Physical capability of Flexion Extension - Lateral Bending Rotation. Minimizing the scratching by TIN coating. Both types have threaded surfaces for easy fixation to the cervical vertebra. CERVICAL PEEK DISC PROTHESIS Made of implantable grade titanium alloy (Ti6AL4V-ELI) material which is congruent with ISO and ASTM-F 136 standards. Made of implantable grade polyetheretherketone (PEEK) material which is compatible with ASTM-F 2026 and USP IV standards and the rod markers are made of Ti6AL4V-ELI material which is compatible with ISO and ASTM-F 136 standards. Both materials are biocompatible. Indications EFSPINE Cervical Disc Prosthesis is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following discectomy at one level or two contiguous levels for intractable radiculopathy (arm pain and/or neurological deficit) with or without neck pain, or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions confirmed by radiographic imaging: herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height compared to adjacent levels. EFSPINE Cervical Disc Prostheses are implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment or demonstrated progressive signs or symptoms despite non-operative treatment prior to implantation of the prosthesis. One step insertion, with no additional exposure or operative steps required for keel or screw placement

6 CERVICAL PEEK CAGE Cervical Peek Cage Efspine Cervical peek cage is designed to provide structural support as an interbody spacer for anterior cervical fusions. The superior and inferior surfaces allow for intimate contact with the endplate surfaces for optimum stability and to resist subsidence. Windows allow bony growth to form a biological fusion. Radiopaque titanium-eli rod markers for improved positioning and easy MR imaging. - Anatomical and convex shape - The teeth structure helps secure placement and prevents migration. - Wide range of sizes - Simple Instrument design for easier and faster surgery - Radiopaque markers allows for MR imaging Made of implantable grade polyetheretherketone (PEEK) material which is compatible with ASTM-F 2026 and USP IV standards and the rod markers are made of Ti6AL4V-ELI material which is compatible with ISO and ASTM-F 136 standards. Both materials are biocompatible. Indications EFSPINE Cervical PEEK Cage system is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. EFSPINE Cervical PEEK Cage implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using with bone substitutes. Efspine Cervical peek Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

7 CERVICAL BLADED PEEK CAGE Cervical Bladed Cage EFSPINE Cervical bladed peek cage has a unique design and is available in various heights to restore the interbody space. The anatomic design and the blade help for a secure and better placement. Locking Blade Mechanism - Threaded surface - 2 angle for easy fixation to vertebra - Ti6AL4V-ELI rod marker - Large area for bone substitute grafting - Simple Instrument design for easier and faster surgery Made of implantable grade polyetheretherketone (PEEK) material which is compatible with ASTM-F 2026 and USP IV standards and the rod markers are made of Ti6AL4V-ELI material which is compatible with ISO and ASTM-F 136 standards. Both materials are biocompatible. Indications EFSPINE Cervical bladed peek cage is indicated for Cervical disc herniation (CDH) Anterior cervical discectomy (ACD) Anterior cervical discectomy and fusion (ACDF) diseases. EFSPINE Cervical PEEK Cage implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using with bone substitutes.

8 CERVICAL EXPANDABLE CAGE CRVICAL EXPANDABLE CAGE Convex-shaped Implants are designed to fit patient anatomy and to allow more accurate sizing Teeth on the surface reduce likelihood of expulsion Self-distractible Made of implantable grade polyetheretherketone (PEEK) material which is compatible with ASTM-F 2026 and USP IV standards and the rod markers and expand pin are made of Ti6AL4V-ELI material which is compatible with ISO and ASTM-F 136 standards. Both materials are biocompatible. For providing easy fixation to the cervical vertebra. Efspine cervical expandable cage have threaded surfaces and expand pin with expandig motion. Unextended Extended Indications Herniated disc with disc compression Degenerative disorders (cervical osteoarthritis with disc compression, uncal osteoarthritis, cervico-brachial neuralgia) Post-traumatic or degenerative instability with cervical anti or retrolisthesis

9 CERVICAL EXPANDABLE BLADED CAGE CERVICAL EXPANDABLE BLADED CAGE Expandable cervical bladed peek cage is available in a variety of sizes to allow the surgeon to choose what is best suited to the patient s anatomy and pathology. Made of implantable grade polyetheretherketone (PEEK) material which is compatible with ASTM-F 2026 and USP IV standards and the rod markers, expend pin and the blade are made of Ti6AL4V-ELI material which is compatible with ISO and ASTM-F 136 standards. Both materials are biocompatible. Titanium blade is guided through the cage, engaging with the posterior and anterior aspects of the device, and lock into the bone to maximize segment stability and expand for minimize micro-motion. Unextended Extended Indications - Cervical Disc hernia - Cervical Unbalanced discoplasty degeneration - Cervical Disc height restoration diseases with anterior approach

10 CERVICAL DISC PROTHESIS CERVICAL DISC PROTHESIS L Disc Height (mm) H W Referance Code Description Size Height Material A CERVICAL DISC PROTHESIS PEEK 4.0 MM PEEK A CERVICAL DISC PROTHESIS PEEK 4.5 MM PEEK A CERVICAL DISC PROTHESIS PEEK 5.0 MM PEEK A CERVICAL DISC PROTHESIS PEEK 5.5 MM PEEK A CERVICAL DISC PROTHESIS PEEK 6.0 MM PEEK A CERVICAL DISC PROTHESIS PEEK 6.5 MM PEEK A CERVICAL DISC PROTHESIS PEEK 7.0 MM PEEK A CERVICAL DISC PROTHESIS PEEK 7.5 MM PEEK A CERVICAL DISC PROTHESIS PEEK 8.0 MM PEEK A CERVICAL DISC PROTHESIS PEEK 8.5 MM PEEK A CERVICAL DISC PROTHESIS PEEK 9.0 MM PEEK A CERVICAL DISC PROTHESIS TITANYUM 4.0 MM TITANYUM A CERVICAL DISC PROTHESIS TITANYUM 4.5 MM TITANYUM A CERVICAL DISC PROTHESIS TITANYUM 5.0 MM TITANYUM A CERVICAL DISC PROTHESIS TITANYUM 5.5 MM TITANYUM A CERVICAL DISC PROTHESIS TITANYUM 6.0 MM TITANYUM A CERVICAL DISC PROTHESIS TITANYUM 6.5 MM TITANYUM A CERVICAL DISC PROTHESIS TITANYUM 7.0 MM TITANYUM A CERVICAL DISC PROTHESIS TITANYUM 7.5 MM TITANYUM A CERVICAL DISC PROTHESIS TITANYUM 8.0 MM TITANYUM A CERVICAL DISC PROTHESIS TITANYUM 8.5 MM TITANYUM A CERVICAL DISC PROTHESIS TITANYUM 9.0 MM TITANYUM

11 CERVICAL PEEK CAGE CERVICAL CAGE L Cage Height (mm) H W Referance Code Description Size Height Material A CERVICAL PEEK CAGE 12X12X4 PEEK A CERVICAL PEEK CAGE 12X12X5 PEEK A CERVICAL PEEK CAGE 12X12X6 PEEK A CERVICAL PEEK CAGE 12X12X7 PEEK A CERVICAL PEEK CAGE 12X12X8 PEEK A CERVICAL PEEK CAGE 12X12X9 PEEK A CERVICAL PEEK CAGE 12X14X4 PEEK A CERVICAL PEEK CAGE 12X14X5 PEEK A CERVICAL PEEK CAGE 12X14X6 PEEK A CERVICAL PEEK CAGE 12X14X7 PEEK A CERVICAL PEEK CAGE 12X14X8 PEEK A CERVICAL PEEK CAGE 12X14X9 PEEK A CERVICAL PEEK CAGE 14X16X4 PEEK A CERVICAL PEEK CAGE 14X16X5 PEEK A CERVICAL PEEK CAGE 14X16X6 PEEK A CERVICAL PEEK CAGE 14X16X7 PEEK A CERVICAL PEEK CAGE 14X16X8 PEEK A CERVICAL PEEK CAGE 14X16X9 PEEK

12 CERVICAL BLADED PEEK CAGE CERVICAL BLADED CAGE L Cage Height (mm) H W Referance Code Description Size Height Material A CERVICAL BLADED PEEK CAGE 14X16X4 PEEK A CERVICAL BLADED PEEK CAGE 14X16X5 PEEK A CERVICAL BLADED PEEK CAGE 14X16X6 PEEK A CERVICAL BLADED PEEK CAGE 14X16X7 PEEK A CERVICAL BLADED PEEK CAGE 14X16X8 PEEK A CERVICAL BLADED PEEK CAGE 14X16X9 PEEK A CERVICAL BLADED PEEK CAGE 14X16X10 PEEK

13 CERVICAL EXPANDABLE CAGE CERVICAL EXPANDABLE CAGE L Cage Height (mm) H W Referance Code Description Size Height Material A CERVICAL EXPANDABLE PEEK CAGE 14X4 PEEK A CERVICAL EXPANDABLE PEEK CAGE 14X5 PEEK A CERVICAL EXPANDABLE PEEK CAGE 14X6 PEEK A CERVICAL EXPANDABLE PEEK CAGE 14X7 PEEK A CERVICAL EXPANDABLE PEEK CAGE 14X8 PEEK A CERVICAL EXPANDABLE PEEK CAGE 14X9 PEEK A CERVICAL EXPANDABLE PEEK CAGE 14X10 PEEK

14 CERVICAL EXPANDABLE BLADED CAGE CERVICAL BLADED CAGE L Cage Height (mm) H W Referance Code Description Size Height Material A CERVICAL EXPANDABLE BLADED PEEK CAGE 14X4 PEEK A CERVICAL EXPANDABLE BLADED PEEK CAGE 14X5 PEEK A CERVICAL EXPANDABLE BLADED PEEK CAGE 14X6 PEEK A CERVICAL EXPANDABLE BLADED PEEK CAGE 14X7 PEEK A CERVICAL EXPANDABLE BLADED PEEK CAGE 14X8 PEEK A CERVICAL EXPANDABLE BLADED PEEK CAGE 14X9 PEEK A CERVICAL EXPANDABLE BLADED PEEK CAGE 14X10 PEEK

15 INSTRUMENT AWL Fixed tip for marking Pin Driver -Self drilling tips for stabilazing both arms of the distractor Caspar Self-Drilling Distraction Pins It is used for soft tissue retraction in anterior cervical discectomy and fusion procedures. The side loading mechanism allows for easy and fast intra-operative handling. Retractor has tilting butterfly screw, preferably used for transverse retraction.

16 INSTRUMENT Cervical Cage Implant Holder Efspine implants are convenient to use with Efspine and FX brand instruments. FX or Efspine implant holder and driver are designed as ergonomic for hand, compact and functional hand tool to prevent various hand tool usage. Redundant tools are eliminated with Cervical combined set instruments by excellent design. The excellent design of EFSPINE set can able to reduce the operation time. Expandable Cervical Cage Holder Cervical Disc Prosthesis Holder Cervical Cage Driver Cervical cage driver with three different tips Mallet The Mallet is used for at the end of the implant insertion for placing the cage or disc prosthesis tightly.

17 INSTRUMENT CAGE ORGANIZER BOX CERVICAL BOX All cervical cage and prosthesis types are presented in a single set.

18 INSTRUMENT Curette After decompressing the spinal cord and nerve roots, the surgeon prepares the endplates using the curette without damaging the underlying cortical bone. The curette has three different head sizes. Implant Trail Rod The implant trail rod with two different functions; one side is the trial cage and the other one is used as the rasp. This feature provides the operational time is reduced. Slicone body handle provides easy to grip. 5 mm, 5,5 mm, 6 mm, 6,5 mm, 7mm, 8mm,

19 SURGICAL TECHNIQUE AWL Preparing the screw hole Pin Driver Provide to create a pilot hole in the cervical vertebral body

20 SURGICAL TECHNIQUE Caspar The disc space can be prepared by turning the knob prior to discectomy

21 SURGICAL TECHNIQUE Curette Preparing the endplates using the curette without damaging the underlying cortical bone.

22 SURGICAL TECHNIQUE Implant Trial Rod To assist in determining the appropriate cage, the trial should fit and produce a tight fit in the disc space. Also rasp side of the trail can be used for creating the appropriate distance. Rasp side Trial side

23 SURGICAL TECHNIQUE Bladed Cervical Cage Blue impactor works as the blade stabilizer. Blade can be rotated up to 90 o. Expandable Cervical Cage Red impactor provides the expandable motion o 2 Expandable Bladed Cervical Cage 1. Step Red impactor provides the expandable motion. 2. Step Black impactor rotates the blade up to 90 o and works as the blade stabilizer. Load the implant onto the Inserter. Turn the proper impaction knob on the Inserter until the impactor holder tip is completely stabilized onto, and just in contact with the Implant Inserter. Implant inserter is suitable to use with different impactors which are congruent to the varied cages. During the implantation, implant inserter is immobilized; only impactors are changed.

24 SURGICAL TECHNIQUE Cervical Cage Efspine cervical peek cage is attached to the implant Inserter Tip, the assembly should be carefully impacted into the disc space with a mallet. Into the disc space in the midline of the vertebra and release the Implant Holder.

25 CERVICAL CAGE SURGICAL TECHNIQUE Cervical Disc Prothesis Efspine cervical disc prosthesis is attached to the implant Inserter Peek Tip, the assembly should be carefully impacted into the disc space with a mallet. Insert the cervical disc prosthesis into the disc space in the midline of the vertebra and release the Implant Holder.

26 SET Cervical Expandable / Bladed Cage Implant Inserter Cervical Disc Prothesis Implant Inserter Cervical Cage Implant Inserter Implant Trial Rod 6x Size Curette 3x Size Mallet Pin 2X Caspor Cervical Cage Driver 3x Size Pin Driver AWL

27 SET Referance Code Description Size Piece Material Cervical Expandable / Bladed Cage Implant Inserter Cervical Disc Prothesis Implant Inserter Cervical Cage Implant Inserter Implant Trial Rod Implant Trial Rod Implant Trial Rod Implant Trial Rod PEEK PEEK PEEK PEEK PEEK PEEK PEEK Implant Trial Rod Implant Trial Rod Curette Curette Curette AWL Pin Driver Cervical Cage Driver Cervical Cage Driver Cervical Cage Driver Caspor Pin 2 Malet

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