CROSS -FUSE P E E K V B R / I B F SYST E M

S U R G I C A L T E C H N I Q U E CROSS -FUSE P E E K V B R / I B F SYST E M S U R G I C A L S Y S T E M O V E R V I E W

2 CROSS-FUSE P E E K V B R / I B F S Y S T E M

S U R G I C A L T E C H N I Q U E Table of Contents INTRODUCTION Indications, Warnings, Precautions, Contraindications 1 System Overview 3 SURGICAL TECHNIQUE OVERVIEW Step 1 EMG Monitoring 5 Step 2 Disc Space Access 5 Step 3 Visualization of the Operative Space 5 Step 4 Discectomy/End Plate Preparation 5 Step 5 Trial Spacers 5 Step 6 Implant Selection 6 Step 7 Implant Insertion 7 Step 8 Radiographic Verification 7 PRODUCT INFORMATION Parts List 8 3

CROSS-FUSE P E E K V B R / I B F S Y S T E M Introduction I N D I C A T I O N S Cross-Fuse PEEK implants are indicated as both Interbody Fusion Devices (IBFs) and Vertebral Body Replacements (VBRs). Pioneer VBRs are intended for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. Pioneer VBRs are also indicated for treating fractures of the thoracic and lumbar spine. Pioneer VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. Pioneer VBRs must be used with the Pioneer Quantum Spinal Fixation System or supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5). Additionally, Pioneer VBRs are intended to be used with bone graft. Pioneer IBFs are indicated for intervertebral body fusion of the spine in skeletally mature patients. Pioneer IBFs are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. Pioneer IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as the Quantum System. Lumbar IBFs are also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Lumbar IBFs are to be used in patients who have had six months of non-operative treatment. W A R N I N G S One of the potential risks identified with this system is death. Other potential risks which may require additional surgery, include: device component fracture loss of fixation non-union fracture of the vertebrae neurological injury vascular or visceral injury The components of this device are manufactured from a radiolucent polymer and include either Titanium or Tantalum (Ta) radiographic markers. Mixing of implant components with different materials is not recommended, for metallurgical, mechanical and functional reasons. P R E C A U T I O N S The implantation of IBFs, VBRs and supplemental internal fixation should be performed only by experienced spinal surgeons with specific training in the use of this system as this is a technically demanding procedure presenting a risk of serious injury to the patient. Preoperative planning and patient anatomy should be considered when selecting implant size and supplemental internal fixation. IBFs and VBRs (regardless of the indication for which they are designated) are designed to withstand both full load bearing and the loads associated with long-term use which could result from the presence of non-union or delayed union. To ensure load-bearing ability and the loads associated with long-term use, supplemental fixation is required with the use of this device. Please refer to the product specific insert for these types of device systems for additional information, (i.e., descriptions, indications, etc.). 1

S U R G I C A L T E C H N I Q U E While proper selection can help minimize risks, the size and shape of human bones present limitations on the size, shape, and strength of implants. Internal fixation devices cannot withstand activity levels equal to those placed on normal healthy bone. These devices can break when subjected to the increased loading associated with delayed union or nonunion. Typically, internal fixation appliances are load-sharing devices which hold a fracture in alignment until healing occurs. If healing is delayed, or does not occur, an implant could eventually break due to fatigue. Loads produced by weight bearing and activity levels will dictate the longevity of the implant. The patient should understand that stress on an implant could involve more than weight bearing. In the absence of solid bony union, patient weight alone, muscular forces associated with moving, or repeated stresses of apparent relatively small magnitude, can compromise the implant. Patients should be fully informed of the risks of implant failure. Correct handling of the implant is extremely important. Notches or scratches put in the implant during the course of surgery may also contribute to breakage. Alterations will produce defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant. Surgical implants must never be reused. An explanted implant should never be reimplanted. Even though the device appears undamaged, it may have small defects and internal stress patterns which may lead to early breakage. After treatment of an interbody or vertebral body fracture and identification of the presence of fusion only the supplemental fixation component of a vertebral body replacement system should be removed. Certain degenerative diseases or underlying physiological conditions such as diabetes or rheumatoid arthritis may alter the healing process, thereby increasing the risk of implant breakage. Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without a previous surgery. C O N T R A I N D I C A T I O N S Use of Pioneer IBFs is contraindicated when: An active infection is present at the operative site or with an allergy to PEEK, titanium, titanium alloy or tantalum A prior fusion at the level(s) to be treated Any condition not described in the indications for use is present Use of the Pioneer VBRs is contraindicated when: There is active systemic infection, infection localized to the site of the proposed implantation, or when the patient has demonstrated allergy or foreign body sensitivity to any of the implant materials. Severe osteoporosis may prevent adequate fixation and thus preclude the use of this or any other orthopaedic implant. Conditions that may place excessive stresses on bone and implants, such as severe obesity or degenerative diseases, are relative contraindications. The decision whether to use these devices in such conditions must be made by the physician taking into account the risks versus the benefits to the patient. Use of these implants is relatively contraindicated in patients whose activity, mental capacity, mental illness, alcoholism, drug abuse, occupation, or lifestyle may interfere with their ability to follow postoperative restrictions and who may place undue stresses on the implant during bony healing and may be at a higher risk of implant failure. *See product insert for complete labeling limitations related to this device. 2

CROSS-FUSE P E E K V B R / I B F S Y S T E M Introduction SYSTEM OVERVIEW - IMPLANT 1 BULLET-SHAPED TIP Aids in ease of implant insertion. 4 2 3 BACK-CUTTING TEETH Resist migration. ANATOMICALLY DESIGNED 1mm of convexity. Parallel or 2 3 lordotic option available. 4 LARGE GRAFT AREA For maximum fusion potential. 1 6 5 5 PEEK-OPTIMA MATERIAL A material with proven clinical history which provides structural strength to support the anterior column of the spine. It is also radiolucent and biocompatible. 6 HIGHLY VISIBLE TANTALUM MARKERS Provides optimal placement verification through radiographic imaging. 6 Lordosis NOTE: Anterior is written on implant for proper orientation during implantation. Posterior Anterior 3

S U R G I C A L T E C H N I Q U E SYSTEM OVERVIEW - INSTRUMENTS 50mm 40mm Detachable Trial Spacers 35-DTRLX-Y-Z Innovative design Spacers are approximately 1mm shorter in height than the corresponding implant Detachable quick release handle for ease of use Heights: 9mm -15mm, in 2mm increments Lordosis: 0, 6 Widths: 14mm, 18mm, 22mm 55mm 45mm The innovative trial spacer design provides incremental grooves. The first indent on all trial spacers is 40mm. Each subsequent indent is 5mm. X = Width, Y = Height and Z = Lordosis T-Handle 35-THANDLE Inserter 35-INSERTER-X Slaphammer 30-T-SLAPHAMMER Tamp 35-TAMP Quick release allows for ease of use Widths: 14mm, 18mm* Efficient in removing implants or Trial Spacers, if necessary For final positioning Trial Spacer Key-Lock and Slaphammer attachment *22mm implants utilize the 18mm Inserter 4

CROSS-FUSE P E E K V B R / I B F S Y S T E M Surgical Technique STEP 1 EMG MONITORING Many surgeons choose to use EMG monitoring with the Cross-Fuse Interbody Fusion Device (IBF) and Vertebral Body Replacement (VBR) system approach. STEP 2 DISC SPACE ACCESS A lateral retractor system is necessary to gain access to the disc space area. Access the operative site and retract tissues to allow for complete exposure and visualization. STEP 3 VISUALIZATION OF THE OPERATIVE SPACE Attach a light source to the retractor for better visualization. Bipolar cautery is used to prepare disc annulus visualization. STEP 4 DISCECTOMY/ END PLATE PREPARATION Prepare the resected space by performing a discectomy. Use Pioneer s preparatory instruments provided (including Lateral Fusion Instruments) to prepare the resected space. Select the desired instruments and/or shavers to debulk disc material and to remove cartilaginous endplates or vertebra, as necessary. Remove loose tissue with pituitary rongeurs. Perforate the bony endplates to expose bleeding bone. STEP 5 TRIAL SPACERS If significant disc space collapse is present, use the 9mm spreader from the Lateral Fusion Instruments as an initiator (6mm height x 9mm width). See Figure 1. 50mm Figure 1 - Lateral Fusion 9mm width spreader 5

S U R G I C A L T E C H N I Q U E Insert a trial spacer (Figure 2) into the resected space to determine the desired implant width, height, and angle (parallel or 6 lordosis) by using radiographic images. The first groove on all trial spacers is 40mm, with subsequent grooves every 5mm. Insert a trial spacer based on preferred implant size. Figure 2 - Trial Spacer NOTE: The 40mm groove on all trial spacers is for consistency, the 40mm implants are optional and must be ordered individually. Remove the detachable quick-release handle of the trial spacer from the shaft (Figure 3). Verify the trial spacer size and placement in the resected space using fluoroscopic guidance. STEP 6 IMPLANT SELECTION Standard Implant Set There are 22 implants in the Standard Implant Set (9mm-15mm heights in 2mm increments and 45mm, 50mm and 55mm lengths). Standard implants are all parallel and available in 14mm or 18mm widths. (Please refer to the Standard Implant Set chart on Page 8 for a complete list of implant sizes.) Figure 3 - Quick Release Handle Optional Lordotic Implant Set A set that includes 19 optional lordotic implants is also available. The implants are available in 14mm and 18mm widths, with a 6 lordotic angle. (Please refer to the Optional Lordotic Implant Set chart on Page 8 for a complete list of implant sizes.) Optional Individual Implant Set There are also 53 optional individual implants available upon request. (Please refer to the Optional Loaner Sets chart on page 9 for a complete list of implant sizes.) 6

CROSS-FUSE P E E K V B R / I B F S Y S T E M STEP 7 IMPLANT INSERTION Pack the selected implant with indicated graft material. Attach the selected implant to the inserter (Figure 4). Ensure that the implant is fully seated and flush to the inserter. Insert implant across the resected space. Confirm implant placement by utilizing A/P and lateral fluoroscopy. NOTE: The 14mm width implants utilize the 14mm Inserter. Both the 18mm and 22mm width implants utilize the 18mm Inserter. Figure 4 - Implant Insertion STEP 8 RADIOGRAPHIC VERIFICATION With the patient in the lateral position, verify proper implant placement with A/P and lateral fluoroscopic images. The highly visible tantalum markers provide 3-D radiographic size and placement verification. Ensure an accurate A/P and lateral C-Arm fluoroscopic image is obtained. For lateral imaging, position the C-Arm machine such that the superior endplate of the level being imaged is parallel and looks like a flat black line. The A/P image will require parallel superior endplates of the level being imaged as well as an image positioning the spinous process in the center of the vertebral body. 1mm 2mm Figure 5-14mm and 18mm Width A/P View 14mm and 18mm Width The A/P view should show three vertical markers (Figure 5). Figure 6-14mm and 18mm Width Lateral View The lateral view should show two vertical markers. The anterior side may have two vertical pins close to one another (Figure 6). 22mm Width The A/P view should show two vertical markers at the anterior and posterior faces of the implant, with one dot in the center (Figure 7). 2mm 3mm Figure 7-22mm Width A/P View The lateral view should show one vertical marker and two horizontal markers centered vertically at the anterior and posterior faces of the implant (Figure 8). 7mm Figure 8-22mm Width Lateral View 7

S U R G I C A L T E C H N I Q U E Product Information See implant charts for measurements. A) Anterior (Max) Height B) Width C) Length STANDARD IMPLANT SET (35-LS-IMP-L) Part Number Anterior Height (A) Posterior Height Width (B) Length (C) Lordosis Graft Vol. (cc s) 35-1445-9 9 9 14 45 0 2 35-1450-9 9 9 14 50 0 3 35-1455-9 9 9 14 55 0 3 35-1845-9 9 9 18 45 0 3 35-1850-9 9 9 18 50 0 4 35-1855-9 9 9 18 55 0 4 35-1445-11 11 11 14 45 0 3 35-1450-11 11 11 14 50 0 3 35-1455-11 11 11 14 55 0 4 35-1845-11 11 11 18 45 0 4 35-1850-11 11 11 18 50 0 4 35-1855-11 11 11 18 55 0 5 35-1445-13 13 13 14 45 0 3 35-1450-13 13 13 14 50 0 4 35-1455-13 13 13 14 55 0 4 35-1845-13 13 13 18 45 0 5 35-1850-13 13 13 18 50 0 5 35-1855-13 13 13 18 55 0 6 35-1450-15 15 15 14 50 0 4 35-1455-15 15 15 14 55 0 5 35-1850-15 15 15 18 50 0 6 35-1855-15 15 15 18 55 0 7 OPTIONAL LORDOTIC IMPLANT SET (35-LS-IMP-L-F) Part Number Anterior Height (A) Posterior Height Width (B) Length (C) Lordosis Graft Vol. (cc s) 35-1445-9-6 9 7.5 14 45 6 2 35-1450-9-6 9 7.5 14 50 6 2 35-1455-9-6 9 7.5 14 55 6 2 35-1850-9-6 9 7 18 50 6 3 35-1855-9-6 9 7 18 55 6 4 35-1445-11-6 11 9.5 14 45 6 3 35-1450-11-6 11 9.5 14 50 6 3 35-1455-11-6 11 9.5 14 55 6 3 35-1850-11-6 11 9 18 50 6 4 35-1855-11-6 11 9 18 55 6 5 35-1445-13-6 13 11.5 14 45 6 3 35-1450-13-6 13 11.5 14 50 6 4 35-1455-13-6 13 11.5 14 55 6 4 35-1850-13-6 13 11 18 50 6 5 35-1855-13-6 13 11 18 55 6 6 35-1450-15-6 15 13.5 14 50 6 4 35-1455-15-6 15 13.5 14 55 6 5 35-1850-15-6 15 13 18 50 6 6 35-1855-15-6 15 13 18 55 6 7 8

CROSS-FUSE P E E K V B R / I B F S Y S T E M OPTIONAL LOANER SETS 35-LS-OPTIONAL Part Number Anterior Height (A) Posterior Height Width (B) Length (C) Lordosis Graft Vol. (cc s) 35-1440-7 7 7 14 40 0 1 35-1445-7 7 7 14 45 0 2 35-1450-7 7 7 14 50 0 2 35-1440-9 9 9 14 40 0 2 35-1840-9 9 9 18 40 0 3 35-1845-9-6 9 7 18 45 6 3 35-1440-11 11 11 14 40 0 2 35-1840-11 11 11 18 40 0 3 35-1845-11-6 11 9 18 45 6 3 35-1440-13 13 13 14 40 0 3 35-1840-13 13 13 18 40 0 4 35-1845-13-6 13 11 18 45 6 4 35-1440-15 15 15 14 40 0 3 35-1445-15 15 15 14 45 0 4 35-1845-15 15 15 18 45 0 5 35-1845-15-6 15 13 18 45 6 5 35-LS-OPTION-LG Part Number Anterior Height (A) Posterior Height Width (B) Length (C) Lordosis Graft Vol. (cc s) 35-1850-17 17 17 18 50 0 7 35-1850-17-6 17 15 18 50 6 7 35-1855-17 17 17 18 55 0 7 35-1855-17-6 17 15 18 55 6 8 35-1860-17-6 17 15 18 60 6 8 35-1860-9 9 7 18 60 0 4 35-1860-9-6 9 7 18 60 6 4 35-1860-11 11 9 18 60 0 5 35-1860-11-6 11 9 18 60 6 5 35-1860-13 13 11 18 60 0 6 35-1860-13-6 13 11 18 60 6 6 35-1860-15 15 13 18 60 0 7 35-1860-15-6 15 13 18 60 6 7 35-LS-OPTION-22 Part Number Anterior Height (A) Posterior Height Width (B) Length (C) Lordosis Graft Vol. (cc s) 35-2245-9 9 9 22 45 0 3 35-2250-9 9 9 22 50 0 3 35-2255-9 9 9 22 55 0 4 35-2245-9-6 9 6.7 22 45 6 2 35-2250-9-6 9 6.7 22 50 6 3 35-2255-9-6 9 6.7 22 55 6 3 35-2245-11 11 11 22 45 0 4 35-2250-11 11 11 22 50 0 4 35-2255-11 11 11 22 55 0 5 35-2245-11-6 11 8.7 22 45 6 3 35-2250-11-6 11 8.7 22 50 6 4 35-2255-11-6 11 8.7 22 55 6 4 35-2245-13 13 13 22 45 0 4 35-2250-13 13 13 22 50 0 5 35-2255-13 13 13 22 55 0 6 35-2245-13-6 13 10.7 22 45 6 4 35-2250-13-6 13 10.7 22 50 6 4 35-2255-13-6 13 10.7 22 55 6 5 35-2245-15 15 15 22 45 0 5 35-2250-15 15 15 22 50 0 6 35-2255-15 15 15 22 55 0 7 35-2245-15-6 15 12.7 22 45 6 5 35-2250-15-6 15 12.7 22 50 6 5 35-2255-15-6 15 12.7 22 55 6 6 9

S U R G I C A L T E C H N I Q U E Notes 10

CROSS-FUSE P E E K V B R / I B F S Y S T E M Notes 11

S U R G I C A L T E C H N I Q U E 12

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