EXCELLA ll. Spinal System

EXCELLA ll Spinal System

Excella II Spinal System INDICATIONS FOR USE The Innovasis Excella II Spinal System is intended for use in the non-cervical area of the spine. WARNING: The safety and effectiveness of pedicle screw systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grade 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The safety and effectiveness of these devices for any other conditions are unknown. Note: The Excella II Spinal System has not been evaluated for safety and compatibility in the MR environment. The Excella II Spinal System has not been tested for heating or migration in the MR environment. The safety of the Excella II Spinal System in the MR environment is unknown. CAUTION: Federal Law (U.S.A.) restricts these devices to sale by or on order of a physician. PRODUCT OVERVIEW The Excella II Spinal System is a thoracolumbar system composed of pedicle screws, rods, locking caps and transverse cross links. All implants are manufactured from biocompatable materials and are color coded for visual identification. The system is designed with multiple options to address complex, multi-level cases and accomodate various patient anatomies. INNOVASIS Excella ll Guide / PG 2

IMPLANT OVERVIEW PEDICLE SCREWS Implant Sizes Screw Diameter Length (5mm incremenets) Color 4.75 mm 25-45 mm Lavender 5.5 mm 25-55 mm Green 6.5 mm 25-60 mm Platinum 7.5 mm 30-60 mm Blue 8.5mm 30-60mm Gray EXCELLA II HEAD DESIGN Head is polyaxial, giving 360 of rotation Top loading for easy rod insertion 30 angulation about axis of screw Provides maximum interface contact between the rod and screw head EXCELLA II THREAD DESIGN Aggressive, coarse thread Double lead thread speeds insertion time Self-tapping Tapered tip to ease insertion Tapered transition of minor diameter Available in solid or cannulated versions 1.2mm k-wire for 4.75mm screws 1.5mm k-wire for 5.5mm and larger screws LOCKING CAP Buttress thread ensures proper clamp strength and resists backout WARNING: Locking cap MUST be installed top side up. This is identified by the tapered hexalobe and by the part and lot numbers etched on the top surface. INNOVASIS Excella ll Guide / PG 3

IMPLANT OVERVIEW RODS RODS Curved rods reduce the need to contour Rods are 5.5mm in diameter Both straight and curved rods are provided in a variety of lengths from 35mm to 500mm CROSS CONNECTORS Implant Sizes Type Length Color Fixed 30mm Grey Fixed 35mm Grey Variable 39-45mm Grey Variable 45-57mm Grey Variable 57-81mm Grey INNOVASIS Excella ll Guide / PG 4

INSTRUMENTS OVERVIEW SCREW INSTRUMENTS LA-184 Universal Ratchet Handle LS-170 Pedicle Screw Driver LS-160 Locking Cap Starter Driver LS-129 Locking Cap Driver LA-183 Anti-Torque LA-T100 Torque Wrench, 100 in-lbs. INNOVASIS Excella ll Guide / PG 5

INSTRUMENTS OVERVIEW ROD MANIPULATION INSTRUMENTS LS-153 Implant Rocker LS-045 Rod Peruader LS-150 Rod Bender LS-151 Compressor LS-152 Distractor INNOVASIS Excella ll Guide / PG 6

APPROACH A preoperative plan should be developed to determine the optimum approach and implant construct. The appropriate implants must be selected based on patient anatomy and method of correction. Before the procedure the patient is placed under general anesthesia and positioned prone. The operative area is carefully cleaned and an incision is made at the appropriate levels. A standard posterior approach to the spine is preferred. PEDICLE SCREW HOLE PREPARATION Locate pedicles and remove bone and/ or soft tissue, as needed, using standard instruments. Mark the entrance to the pedicle using the Awl. Insert the Gear Shift Probe into the prepared hole created by the Awl. Insert the Gear Shift Probe to the appropriate depth. Note: Depth markings on the Gear Shift Probe can be used to confirm depth. Confirm the integrity of the pedicle wall using a wire ball feeler probe. Using pedicle markers or probes confirm pedicles with Fluoroscopy or X-ray. INNOVASIS Excella ll Guide / PG 7

PEDICLE SCREW HOLE PREPERATION (CONT.) Excella II screws are self-tapping, however pedicles may be tapped if desired, using taps from the instrument set. Determine the appropriate size tap based on the screw size being implanted. Note: Bone taps are 0.5mm undersized, and are color coded to match the head of the pedicle screw being implanted. PEDICLE SCREW INSERTION Load the Pedicle Screw Driver with the correct screw size and drive the screw into the prepared pedicle. INNOVASIS Excella ll Guide / PG 8

ROD INSERTION Once the screws are in place the appropriate size rod can be selected either by trial or utilizing the Rod Template. If necessary, contour the rod to the desired sagital alignment using the Rod Bender. The contoured rod is inserted into the screws beginning from either end of the construct. The rod should be inserted into the implants that require little or no rod reduction first. The Rod Holder may be used to hold the rod during insertion. INNOVASIS Excella ll Guide / PG 9

LOCKING CAP INSERTION Locking caps are inserted into the implant using the Starter Driver. Caps are inserted first into implants where the rod seats well in the implant and little to no reduction is required. Locking caps are typically inserted in the order of reduction needed, with the screw requiring small reduction first to the more difficult reductions last. The Rod Pusher may be used to assist in the insertion of the rod. Once a locking cap is inserted into an implant it is provisionally tightened. Final tightening will occur later in the procedure. Note: Verify the Locking Caps are oriented with the engraving upward and visible to ensure that the caps are inserted in the correction orientation. INNOVASIS Excella ll Guide / PG 10

ROD REDUCTION The Excella II Spinal System has several options for rod reduction. The rod reduction instruments are designed to seat the rod into the implant. OPTION A: IMPLANT ROCKER To use the Implant Rocker, place instrument on the implant and ratchet the handle closed. Tilt the Implant Rocker to persuade the rod into the implant until a Locking Cap can be inserted. Insert a locking cap and remove the Implant Rocker from the screw or hook. OPTION B: PERSUADER Place the Persuader over the implant head and push it down until the instrument touches the rod. Once the instrument is in place squeeze the grip handle to reduce the rod into the implant head. The instrument will provide up to 30mm of reduction. Once the rod is fully seated into the implant head a Locking Cap can be inserted through the cannula of the Persuader and provisionaly tightened. INNOVASIS Excella ll Guide / PG 11

COMPRESSION OR DISTRACTION After the rod is secured in the implants, compression and/or distraction may be performed. The Compressor or Distractor is used by tightening one of the Locking Caps, to establish a rigid point for the procedure. Once compression or distraction is completed the second Locking Cap is final tightened. INNOVASIS Excella ll Guide / PG 12

FINAL TIGHTENING Final tightening is performed once the spine is fixed in a satisfactory position. Using the anti-torque and the torque wrench tighten each locking cap until an audible click is heard. The Excella II locking caps are final tightened to 11.3 Nm (100 in-lbs.) Note: The anti-torque must be used for final tightening. Note: Gently rock the anti-torque in the cranial-caudal direction while tightening the locking cap. This will ensure the rod is seated in the tulip. Failure to seat the rod may result in loosening of the construct when the patient moves. INNOVASIS Excella ll Guide / PG 13

CROSS CONNECTOR PLACEMENT The Excella cross link is designed to be used as a construct stabilizer to increase rotational stiffness. Select a cross link of the appropriate length and place onto the rod within the construct in the desired location. The cross link is final tightened to 40 in-lbs using the Torque Limiting handle. The center screw of variable length cross links is also final tightened to 40 in-lbs. Note: If the screws have come out of the cross link body during transit or washing, replace them using the cross link driver. The cone shaped set screws go in the outer positions, and the flat set screw goes in the middle position. INNOVASIS Excella ll Guide / PG 14

IMPLANT REMOVAL Excella II implants are removed in the same manner they are installed. The locking caps should be loosened using the Anti-Torque, Universal Ratchet Handle and the Locking Cap Driver. Note: Torque Wrenches and Starter Drivers should never be used to loosen locking caps. However, after the locking cap is provisionally loosened, the Starter Driver can be used to engage the locking cap using the stab-and-grab feature retaining the cap to the driver and easing removal. Once the locking caps have been extracted, the rods should be removed. After the rods have been removed, the pedicle screws can be removed using the Pedicle Screw Driver. INNOVASIS Excella ll Guide / PG 15

IMPLANTS Solid Pedicle Screws ITEM PART NO. DESCRIPTION STD QTY 1 E2S47525 POLYAXIAL PEDICLE SCREW, 4.75mm X 25mm, EXCELLA-II, STANDARD 6 2 E2S47530 POLYAXIAL PEDICLE SCREW, 4.75mm X 30mm, EXCELLA-II, STANDARD 6 3 E2S47535 POLYAXIAL PEDICLE SCREW, 4.75mm X 35mm, EXCELLA-II, STANDARD 6 4 E2S47540 POLYAXIAL PEDICLE SCREW, 4.75mm X 40mm, EXCELLA-II, STANDARD 6 5 E2S47545 POLYAXIAL PEDICLE SCREW, 4.75mm X 45mm, EXCELLA-II, STANDARD 6 6 E2S5525 POLYAXIAL PEDICLE SCREW, 5.5mm X 25mm, EXCELLA-II, STANDARD 0 7 E2S5530 POLYAXIAL PEDICLE SCREW, 5.5mm X 30mm, EXCELLA-II, STANDARD 6 8 E2S5535 POLYAXIAL PEDICLE SCREW, 5.5mm X 35mm, EXCELLA-II, STANDARD 6 9 E2S5540 POLYAXIAL PEDICLE SCREW, 5.5mm X 40mm, EXCELLA-II, STANDARD 6 10 E2S5545 POLYAXIAL PEDICLE SCREW, 5.5mm X 45mm, EXCELLA-II, STANDARD 6 11 E2S5550 POLYAXIAL PEDICLE SCREW, 5.5mm X 50mm, EXCELLA-II STANDARD 6 12 E2S5555 POLYAXIAL PEDICLE SCREW, 5.5mm X 55mm, EXCELLA-II, STANDARD 6 13 E2S6525 POLYAXIAL PEDICLE SCREW, 6.5mm X 25mm, EXCELLA-II, STANDARD 6 14 E2S6530 POLYAXIAL PEDICLE SCREW, 6.5mm X 30mm, EXCELLA-II, STANDARD 6 15 E2S6535 POLYAXIAL PEDICLE SCREW, 6.5mm X 35mm, EXCELLA-II, STANDARD 6 16 E2S6540 POLYAXIAL PEDICLE SCREW, 6.5mm X 40mm, EXCELLA-II, STANDARD 12 17 E2S6545 POLYAXIAL PEDICLE SCREW, 6.5mm X 45mm, EXCELLA-II, STANDARD 12 18 E2S6550 POLYAXIAL PEDICLE SCREW, 6.5mm X 50mm, EXCELLA-II, STANDARD 6 19 E2S6555 POLYAXIAL PEDICLE SCREW, 6.5mm X 55mm, EXCELLA-II, STANDARD 6 20 E2S6560 POLYAXIAL PEDICLE SCREW, 6.5mm X 60mm, EXCELLA-II, STANDARD 6 21 E2S7530 POLYAXIAL PEDICLE SCREW, 7.5mm X 30mm, EXCELLA-II, STANDARD 6 22 E2S7535 POLYAXIAL PEDICLE SCREW, 7.5mm X 35mm, EXCELLA-II, STANDARD 6 23 E2S7540 POLYAXIAL PEDICLE SCREW, 7.5mm X 40mm, EXCELLA-II, STANDARD 6 24 E2S7545 POLYAXIAL PEDICLE SCREW, 7.5mm X 45mm, EXCELLA-II, STANDARD 6 25 E2S7550 POLYAXIAL PEDICLE SCREW, 7.5mm X 50mm, EXCELLA-II, STANDARD 6 26 E2S7555 POLYAXIAL PEDICLE SCREW, 7.5mm X 55mm, EXCELLA-II, STANDARD 6 27 E2S7560 POLYAXIAL PEDICLE SCREW, 7.5mm X 60mm, EXCELLA-II, STANDARD 6 28 E2S8530 POLYAXIAL PEDICLE SCREW, 8.5mm X 30mm, EXCELLA-II, STANDARD 0 29 E2S8535 POLYAXIAL PEDICLE SCREW, 8.5mm X 35mm, EXCELLA-II, STANDARD 6 30 E2S8540 POLYAXIAL PEDICLE SCREW, 8.5mm X 40mm, EXCELLA-II, STANDARD 6 31 E2S8545 POLYAXIAL PEDICLE SCREW, 8.5mm X 45mm, EXCELLA-II, STANDARD 6 32 E2S8550 POLYAXIAL PEDICLE SCREW, 8.5mm X 50mm, EXCELLA-II, STANDARD 0 33 E2S8555 POLYAXIAL PEDICLE SCREW, 8.5mm X 55mm, EXCELLA-II, STANDARD 0 34 E2S8560 POLYAXIAL PEDICLE SCREW, 8.5mm X 60mm, EXCELLA-II, STANDARD 0 INNOVASIS Excella ll Guide / PG 16

IMPLANTS Cannulated Pedicle Screws ITEM PART NO. DESCRIPTION STD QTY 1 E247525 POLYAXIAL PEDICLE SCREW, 4.75mm X 25mm, EXCELLA-II 0 2 E247530 POLYAXIAL PEDICLE SCREW, 4.75mm X 30mm, EXCELLA-II 0 3 E247535 POLYAXIAL PEDICLE SCREW, 4.75mm X 35mm, EXCELLA-II 0 4 ES47540 POLYAXIAL PEDICLE SCREW, 4.75mm X 40mm, EXCELLA-II 0 5 E247545 POLYAXIAL PEDICLE SCREW, 4.75mm X 45mm, EXCELLA-II 0 6 E25525 POLYAXIAL PEDICLE SCREW, 5.5mm X 25mm, EXCELLA-II 0 7 E25530 POLYAXIAL PEDICLE SCREW, 5.5mm X 30mm, EXCELLA-II 0 8 E25535 POLYAXIAL PEDICLE SCREW, 5.5mm X 35mm, EXCELLA-II 0 9 E25540 POLYAXIAL PEDICLE SCREW, 5.5mm X 40mm, EXCELLA-II 0 10 E25545 POLYAXIAL PEDICLE SCREW, 5.5mm X 45mm, EXCELLA-II 0 11 E25550 POLYAXIAL PEDICLE SCREW, 5.5mm X 50mm, EXCELLA-II 0 12 E25555 POLYAXIAL PEDICLE SCREW, 5.5mm X 55mm, EXCELLA-II 0 13 E26525 POLYAXIAL PEDICLE SCREW, 6.5mm X 25mm, EXCELLA-II 0 14 E26530 POLYAXIAL PEDICLE SCREW, 6.5mm X 30mm, EXCELLA-II 0 15 E26535 POLYAXIAL PEDICLE SCREW, 6.5mm X 35mm, EXCELLA-II 0 16 E26540 POLYAXIAL PEDICLE SCREW, 6.5mm X 40mm, EXCELLA-II 0 17 E26545 POLYAXIAL PEDICLE SCREW, 6.5mm X 45mm, EXCELLA-II 0 18 E26550 POLYAXIAL PEDICLE SCREW, 6.5mm X 50mm, EXCELLA-II 0 19 E26555 POLYAXIAL PEDICLE SCREW, 6.5mm X 55mm, EXCELLA-II 0 20 E26560 POLYAXIAL PEDICLE SCREW, 6.5mm X 60mm, EXCELLA-II 0 21 E27530 POLYAXIAL PEDICLE SCREW, 7.5mm X 30mm, EXCELLA-II 0 22 E27535 POLYAXIAL PEDICLE SCREW, 7.5mm X 35mm, EXCELLA-II 0 23 E27540 POLYAXIAL PEDICLE SCREW, 7.5mm X 40mm, EXCELLA-II 0 24 E27545 POLYAXIAL PEDICLE SCREW, 7.5mm X 45mm, EXCELLA-II 0 25 E27550 POLYAXIAL PEDICLE SCREW, 7.5mm X 50mm, EXCELLA-II 0 26 E27555 POLYAXIAL PEDICLE SCREW, 7.5mm X 55mm, EXCELLA-II 0 27 E27560 POLYAXIAL PEDICLE SCREW, 7.5mm X 60mm, EXCELLA-II 0 28 E28530 POLYAXIAL PEDICLE SCREW, 8.5mm X 30mm, EXCELLA-II 0 29 E28535 POLYAXIAL PEDICLE SCREW, 8.5mm X 35mm, EXCELLA-II 0 30 E28540 POLYAXIAL PEDICLE SCREW, 8.5mm X 40mm, EXCELLA-II 0 31 E28545 POLYAXIAL PEDICLE SCREW, 8.5mm X 45mm, EXCELLA-II 0 32 E28550 POLYAXIAL PEDICLE SCREW, 8.5mm X 50mm, EXCELLA-II 0 33 E28555 POLYAXIAL PEDICLE SCREW, 8.5mm X 55mm, EXCELLA-II 0 34 E28560 POLYAXIAL PEDICLE SCREW, 8.5mm X 60mm, EXCELLA-II 0 INNOVASIS Excella ll Guide / PG 17

IMPLANTS Cross Links ITEM PART NO. DESCRIPTION STD QTY 59 UCL3030 5.5/6.0mm CROSS LINK ASSEMBLY, 30mm 1 60 UCL3535 5.5/6.0mm CROSS LINK ASSEMBLY, 35mm 1 61 UCL3945 5.5/6.0mm CROSS LINK ASSEMBLY, 39-45mm 2 62 UCL4557 5.5/6.0mm CROSS LINK ASSEMBLY, 45-57mm 2 63 UCL5781 5.5/6.0mm CROSS LINK ASSEMBLY, 57-81mm 1 Locking Caps ITEM PART NO. DESCRIPTION STD QTY 64 E2002 LOCKING CAP 24 Rods ITEM PART NO. DESCRIPTION STD QTY 65 SR5535 ROD, STRAIGHT, 5.5mm X 35mm 3 66 SR5540 ROD, STRAIGHT, 5.5mm X 40mm 3 67 SR5545 ROD, STRAIGHT, 5.5mm X 45mm 3 68 SR5550 ROD, STRAIGHT, 5.5mm X 50mm 3 69 SR5555 ROD, STRAIGHT, 5.5mm X 55mm 3 70 SR5560 ROD, STRAIGHT, 5.5mm X 60mm 3 71 SR5570 ROD, STRAIGHT, 5.5mm X 70mm 3 72 SR5580 ROD, STRAIGHT, 5.5mm X 80mm 3 73 SR5590 ROD, STRAIGHT, 5.5mm X 90mm 3 74 SR55100 ROD, STRAIGHT, 5.5mm X 100mm 3 75 SR55110 ROD, STRAIGHT, 5.5mm X 110mm 3 76 SR55120 ROD, STRAIGHT, 5.5mm X 120mm 3 77 SR55460 ROD, STRAIGHT, 5.5mm X 460mm 3 78 PR5535 ROD, PRE-BENT, 5.5mm X 35mm 3 79 PR5545 ROD, PRE-BENT, 5.5mm X 45mm 3 80 PR5555 ROD, PRE-BENT, 5.5mm X 55mm 3 81 PR5565 ROD, PRE-BENT, 5.5mm X 65mm 3 82 PR5575 ROD, PRE-BENT, 5.5mm X 75mm 3 83 PR5585 ROD, PRE-BENT, 5.5mm X 85mm 3 84 PR5595 ROD, PRE-BENT, 5.5mm X 95mm 3 85 PR55105 ROD, PRE-BENT, 5.5mm X 105mm 3 86 PR55115 ROD, PRE-BENT, 5.5mm X 115mm 3 87 PR55125 ROD, PRE-BENT, 5.5mm X 125mm 3 INNOVASIS Excella ll Guide / PG 18

INSTRUMENTS ITEM PART NO. DESCRIPTION STD QTY 1 LS-171 #25 HEXALOBE, DRIVER, SOLID 1 2 LS-062 STRAIGHT GEAR SHIFT, TEARDROP 1 3 LS-063 CURVED GEAR SHIFT, TEARDROP 1 4 LA-184 UNIVERSAL RATCHET HANDLE, CUSTOM 2 5 LS-170 PEDICLE SCREW DRIVER, SOLID 2 6 LS-129 LOCKING CAP DRIVER 2 7 LS-165 BONE TAP, 4.75mm, SOLID 1 8 LS-166 BONE TAP, 5.5mm, SOLID 1 9 LS-167 BONE TAP, 6.5mm, SOLID 1 10 LS-168 BONE TAP, 7.5mm SOLID 1 11 LS-169 BONE TAP, 8.5mm, SOLID 1 12 LS-050 BONE AWL 1 13 LA-183 ANTI-TORQUE 1 14 LS-160 STARTER DRIVER, LOCKING CAP 2 15 LS-072 STRAIGHT PROBE 1 16 LS-073 CURVED PROBE 1 17 LS-045 ROD PERSUADER 1 18 LS-147 FORCEPS, CROSS LINK INSERTER 1 19 LS-153 IMPLANT ROCKER 1 20 LS-010 ROD HOLDER 1 21 LA-T100 TORQUE WRENCH, 100 in-lb 1 22 LA-T40 TORQUE WRENCH, 40 in-lb 1 23 LS-131 DRIVER, CROSS LINK 1 24 LS-150 ROD BENDER, 6.35mm 1 25 LA-153 UNIVERSAL RATCHET HANDLE 1 26 LS-040 ROD PUSHER 1 27 LS-025 DISTRACTOR PLIERS 1 28 LS-030 COMPRESSOR PLIERS 1 29 LS-011 ROD PLIER 1 30 LS-012 POWER GRIP ROD HOLDER 1 INNOVASIS Excella ll Guide / PG 19

INSTRUMENTS Accessories ITEM PART NO. DESCRIPTION STD QTY 1 LS-152 DISTRACTOR, PARALLEL, 1.5 RANGE 0 2 LS-151 COMPRESSOR, PARALLEL, 1.5 RANGE 0 3 LS-157 ROD WRENCH, 4.5mm HEX 0 4 LS-161 ROD REDUCER 0 5 LS-130 STARTER DRIVER, LOCKING CAP 0 6 LS-159 IN SITU BENDER, 5.5mm 0 7 LS-164 HEAD POSITIONER, EXCELLA II 0 8 LS-148 K-WIRE, 1.2mm 0 INNOVASIS Excella ll Guide / PG 20

M Innovasis, Inc. 614 East 3900 South Salt Lake City, UT 84107 Tel: +1 801.261.2236 Tel: 1 877.261.2236 Fax: +1 801.261.0573 Info@Innovasis.com LX202 REV J : Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands