EXACTECH SPINE Operative Technique Cervical Spacer System Surgeon focused. Patient driven. TM
ACAPELLA ONE Acapella One Cervical Spacer System is an anterior cervical discectomy and fusion device with integrated anchors. It is offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions and features single-step implantation with an integrated locking mechanism. The Acapella One Cervical Spacer system features an enclosed chamber intended to be filled with autogenous bone graft material and is intended to be used with supplemental fixation. TABLE OF CONTENTS OPERATIVE TECHNIQUE OVERVIEW...1 DETAILED OPERATIVE TECHNIQUE...2 SURGICAL APPROACH...2 DISTRACTION...2 DISCECTOMY...2 IMPLANT SIZE SELECTION...2 IMPLANT CONNECTION TO INSERTER...3 IMPLANT INSERTION...4 DEPLOYMENT OF INTEGRATED ANCHORS...4 IMPLANT REMOVAL...4 IMPLANT LISTING...5 INSTRUMENT LISTING...6 INDICATIONS FOR USE...9 CONTRAINDICATIONS FOR USE...9 WARNINGS AND PRECAUTIONS...9
OPERATIVE TECHNIQUE OVERVIEW 1 Prepare the Endplates 2 Trial Sizing 3 Attach Implant to Inserter 4 Insert Implant 5 Deploy Anchors 6 Final Locking Tool 1
DETAILED OPERATIVE TECHNIQUE SURGICAL APPROACH Identify the affected level radiographically. Using a standard surgical approach, expose the vertebral bodies to be fused. Prepare the fusion site following the appropriate technique for the given indication. Figure 1 Preparing the Endplates DISTRACTION Use the surgeon s preferred distraction method. If using a caspar distractor, place one distraction pin in the vertebral body superior to the affected level and the other distraction pin in the vertebral body inferior to the affected level. Place the pin distractor over the pins and open as needed to distract the vertebral bodies, using caution not to over distract the vertebral segment. Graft Width Figure 2 Overall Dimensions Graft Depth Width DISCECTOMY Use the surgeon s preferred discectomy instruments and procedure to remove the intervertebral disc and osteophytes as needed. Use the Rasps and Curettes to prepare the endplates just enough to create a surface that will encourage vascularization between the endplates and the graft without weakening cortical bone (Figure 1). Caution: Aggressive preparation of the endplate may remove excessive bone and weaken the endplate. Anchor Height Depth Anterior Height Lordosis Posterior Height IMPLANT SIZE SELECTION Choose a Parallel, Lordotic or Convex Trial Spacer of the appropriate height and footprint. The selection of the Trial Spacer size is dependent upon the height and depth of the intervertebral space and the individual patient anatomy and disc preparation (Figure 2). Figure 3 Anchor Orientation The anchors on the implant are located in the same configuration for the Parallel and Convex version, and in an opposite orientation for the Lordotic version to allow this to be used in a revision procedure if necessary (Figure 3 & 4). Lordotic Parallel Convex A B Figure 4 Anchor Heights A B Lordotic Parallel Convex A B ANCHOR HEIGHTS Implant Heights Dimension Location Lordotic Parallel Convex 5-7mm Superior A 4.4 4.2 4.5 Inferior B 4.4 4.2 4.2 8-10mm Superior A 4.3 4.4 4.2 Inferior B 4.3 4.4 4.4 2
Figure 5 Trial Sizing Insert the appropriate sized Trial into the disc space and check for a secure fit. If necessary, use incrementally larger sizes until a tight fit is obtained. Use radiographic imaging to confirm the implant depth and height as well as endplate coverage (Figure 5). Trials are available with and without depth stops. The stops allow for a maximum of 2mm of countersink into the disc space. Note: The Trials are color coded to indicate whether it is a small or large footprint, and whether it is parallel, lordotic or convex. Figure 6 Attach Implant to Inserter IMPLANT CONNECTION TO INSERTER The implant can be introduced into the disc space by using the Inserter in conjunction with the Double Impactor. Select the appropriate implant size as determined in the Trialing step. Ensure that the Inserter Shaft is removed from the Inserter. Attach the distal tip of the Inserter into the rectangular opening in the anterior face of the implant (Figure 6 & 7). Place the Inserter Shaft into the Inserter to lock the implant in place (Figure 8). Figure 7 Implant Attached to Inserter Turn the green dial clockwise to cinch and lock the implant to the inserter (Figure 9). Once the implant is locked on the inserter, the depth stop on the Inserter can be adjusted from 0mm to 5mm by rotating the blue dial (Figure 10). The depth stop can be oriented in either a cephalad or caudal configuration depending on the anatomical constraints. Note: The Convex Implant version has a pronounced radial dome on the superior side. There is an arrow on the implant to indicate which side is domed. Once the implant is attached to the Inserter, fill the center graft window with autograft. The Graft Loading Base and Graft Impactor can be used if necessary. Figure 8 Insert Shaft to Secure Implant Figure 9 Turn Green Dial to Lock Implant to Inserter Figure 10 Set Depth Stop 3
Figure 12 Radiographic Markers Figure 11 Insert Implant 4mm 2mm 0.5mm 4mm Figure 13 Insert Double Impactor IMPLANT INSERTION Insert the implant into the disc space until the depth stop rests on the anterior surface of the vertebral body (Figure 11). If the implant position is too anterior, the position can be adjusted by changing the depth stop. Rotate the numbered knob by 1mm increments, then advance the implant until the depth stop rests on the anterior surface of the vertebral body. Confirm the final position of the implant under radiographic imaging. Radiographic markers are incorporated in the implant to enable accurate assessment of implant position (Figure 12). DEPLOYMENT OF INTEGRATED ANCHORS Slide the Double Impactor around the Inserter until the Impactor contacts the integrated anchors of the implant (Figure 13). To deploy the integrated anchors, use the Mallet to strike the end of the Double Impactor (Figure 14). To confirm that the anchors are fully deployed, verify that the indicator on the Inserter lines up with the indicator on the Double Impactor (Figure 15). Remove the Double Impactor. Remove the Inserter Shaft from the Inserter to disengage it. Then remove the Inserter from the implant. Note: It is important to ensure that the vertebral bodies are not distracting when deploying the anchors. If this is detectable, un-deploy the anchors and re-deploy. Figure 14 Anchor Deployment 4
FINAL LOCKING OF ANCHORS To confirm that the anchors have been deployed and that the internal locking mechanism is engaged, insert the Final Locking Tool into the center opening of the anterior face of the implant and squeeze the handle to lock. (Figure16). Figure 15 Confirm Final Position IMPLANT REMOVAL If it becomes necessary to remove the Acapella One implant, carefully observe the implant position and the presence of any scar tissue, which can make exposure more challenging compared to the un-operated spine. To remove the Implant, use the Anchor Removal Tool to grasp the anterior end of the anchor and pull back to disengage the anchor from the vertebral body. Once the anchors are disengaged, remove the implant anteriorly using a standard operating instrument like a Kocher. If the implant cannot be easily removed, a Cobb Elevator or Osteotome should be used to loosen the bone to implant interface. Figure 16 Final Locking Tool 5
IMPLANT LISTING Catalog Number 05-090-01-1405 05-090-01-1406 05-090-01-1407 05-090-01-1408 05-090-01-1409 05-090-01-1410 05-090-02-1405 05-090-02-1406 05-090-02-1407 05-090-02-1408 05-090-02-1409 05-090-02-1410 05-090-03-1405 05-090-03-1406 05-090-03-1407 05-090-03-1408 05-090-03-1409 05-090-03-1410 05-090-01-1605 05-090-01-1606 05-090-01-1607 05-090-01-1608 05-090-01-1609 05-090-01-1610 05-090-02-1605 05-090-02-1606 05-090-02-1607 05-090-02-1608 05-090-02-1609 05-090-02-1610 05-090-03-1605 05-090-03-1606 05-090-03-1607 05-090-03-1608 05-090-03-1609 05-090-03-1610 Part Description Lordotic Interbody, 12x14, 5mm Lordotic Interbody, 12x14, 6mm Lordotic Interbody, 12x14, 7mm Lordotic Interbody, 12x14, 8mm Lordotic Interbody, 12x14, 9mm Lordotic Interbody, 12x14, 10mm Parallel Interbody, 12x14, 5mm Parallel Interbody, 12x14, 6mm Parallel Interbody, 12x14, 7mm Parallel Interbody, 12x14, 8mm Parallel Interbody, 12x14, 9mm Parallel Interbody, 12x14, 10mm Convex Interbody, 12x14, 5mm Convex Interbody, 12x14, 6mm Convex Interbody, 12x14, 7mm Convex Interbody, 12x14, 8mm Convex Interbody, 12x14, 9mm Convex Interbody, 12x14, 10mm Lordotic Interbody, 14x16, 5mm Lordotic Interbody, 14x16, 6mm Lordotic Interbody, 14x16, 7mm Lordotic Interbody, 14x16, 8mm Lordotic Interbody, 14x16, 9mm Lordotic Interbody, 14x16, 10mm Parallel Interbody, 14x16, 5mm Parallel Interbody, 14x16, 6mm Parallel Interbody, 14x16, 7mm Parallel Interbody, 14x16, 8mm Parallel Interbody, 14x16, 9mm Parallel Interbody, 14x16, 10mm Convex Interbody, 14x16, 5mm Convex Interbody, 14x16, 6mm Convex Interbody, 14x16, 7mm Convex Interbody, 14x16, 8mm Convex Interbody, 14x16, 9mm Convex Interbody, 14x16, 10mm 6
INSTRUMENT LISTING Catalog Number 05-099-05-1405 05-099-05-1406 05-099-05-1407 05-099-05-1408 05-099-05-1409 05-099-05-1410 05-099-06-1405 05-099-06-1406 05-099-06-1407 05-099-06-1408 05-099-06-1409 05-099-06-1410 05-099-07-1405 05-099-07-1406 05-099-07-1407 05-099-07-1408 05-099-07-1409 05-099-07-1410 05-099-05-1605 05-099-05-1606 05-099-05-1607 05-099-05-1608 05-099-05-1609 05-099-05-1610 05-099-06-1605 05-099-06-1606 05-099-06-1607 05-099-06-1608 05-099-06-1609 05-099-06-1610 05-099-07-1605 05-099-07-1606 05-099-07-1607 05-099-07-1608 05-099-07-1609 05-099-07-1610 Part Description Lordotic Trial 12x14, 5mm Lordotic Trial 12x14, 6mm Lordotic Trial 12x14, 7mm Lordotic Trial 12x14, 8mm Lordotic Trial 12x14, 9mm Lordotic Trial 12x14, 10mm Parallel Trial 12x14, 5mm Parallel Trial 12x14, 6mm Parallel Trial 12x14, 7mm Parallel Trial 12x14, 8mm Parallel Trial 12x14, 9mm Parallel Trial 12x14, 10mm Convex Trial 12x14, 5mm Convex Trial 12x14, 6mm Convex Trial 12x14, 7mm Convex Trial 12x14, 8mm Convex Trial 12x14, 9mm Convex Trial 12x14, 10mm Lordotic Trial 14x16, 5mm Lordotic Trial 14x16, 6mm Lordotic Trial 14x16, 7mm Lordotic Trial 14x16, 8mm Lordotic Trial 14x16, 9mm Lordotic Trial 14x16, 10mm Parallel Trial 14x16, 5mm Parallel Trial 14x16, 6mm Parallel Trial 14x16, 7mm Parallel Trial 14x16, 8mm Parallel Trial 14x16, 9mm Parallel Trial 14x16, 10mm Convex Trial 14x16, 5mm Convex Trial 14x16, 6mm Convex Trial 14x16, 7mm Convex Trial 14x16, 8mm Convex Trial 14x16, 9mm Convex Trial 14x16, 10mm 05-099-01-1200 Inserter 05-099-41-1200 Inserter Shaft 05-099-02-1200 Double Impactor 7
INSTRUMENT LISTING Catalog Number Part Description 05-099-44-2000 Single Impactor 05-099-09-0000 Anchor Removal Tool 05-099-37-0000 Final Locking Tool 05-099-10-0000 Straight Rasp 05-099-14-0000 Straight Ring Curette 05-099-16-0001 Graft Loading Base 05-099-16-0002 Graft Loading Cap 05-099-17-0000 Graft Impactor 05-099-30-0000 Mallet 8
(OPTIONAL) INSTRUMENT LISTING 05-099-39-0000 Cup Curette 2/0 05-099-27-1405 to 1410 Lordotic Trial Spacer with Stop, 12x14, 5mm-10mm 05-099-28-1405 to 1410 Parallel Trial Spacer with Stop, 12x14, 5mm-10mm 05-099-29-1405 to 1410 Convex Trial Spacer with Stop, 12x14, 5mm-10mm 05-099-27-1605 to 1610 Lordotic Trial Spacer with Stop, 14x16, 5mm-10mm 05-099-28-1605 to 1610 Parallel Trial Spacer with Stop, 14x16, 5mm-10mm 05-099-29-1605 to 1610 Convex Trial Spacer with Stop, 14x16, 5mm-10mm 05-099-04-1400 05-099-04-1600 05-099-04-1401 05-099-04-1601 Distractor, 12x14 Footprint Distractor, 14x16 Footprint Short Distractor, 12x14 Footprint Short Distractor, 14x16 Footprint 05-099-31-1405 to 1410 Lordotic Trial Rasp 12x14, 5mm-10mm 05-099-32-1405 to 1410 Parallel Trial Rasp 12x14, 5mm-10mm 05-099-33-1405 to 1410 Convex Trial Rasp 12x14, 5mm-10mm 05-099-31-1605 to 1610 Lordotic Trial Rasp 14x16, 5mm-10mm 05-099-32-1605 to 1610 Parallel Trial Rasp 14x16, 5mm-10mm 05-099-33-1605 to 1610 Convex Trial Rasp 14x16, 5mm-10mm 05-099-11-0000 05-099-11-0001 05-099-12-0000 05-099-12-0001 Angled Rasp Angled Rasp with Stop Convex Rasp Convex Rasp with Stop 05-099-10-0001 Straight Rasp with Stop 05-099-15-0000 Angled Ring Curette 9
INDICATIONS FOR USE The Exactech Acapella One Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Exactech Acapella One Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. CONTRAINDICATIONS FOR USE Contraindications for the Acapella One Cervical Spacer System are similar to those of other systems of similar design, and include, but are not limited to: 1. Active infectious process in the patient, particularly in or adjacent to the spine or spinal structures 2. Morbid obesity. 3. Pregnancy. 4. Grossly distorted anatomy due to congenital abnormalities. 5. Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery. 6. Rapid joint disease, bone absorption, osteopenia, osteomalcia, or osteoporosis. Osteopenia or osteoporosis is a relative contraindication since this condition may limit the degree of obtainable correction and/or the amount of mechanical fixation. 7. Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality. 8. Suspected or documented material allergy or intolerance. 9. Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance. 10. Patients whose activity, mental capacity, mental illness, alcohol or drug abuse, occupation or life-style may interfere with their ability to follow post-operative instructions. 11. Any case not needing an autogenous bone graft and fusion. 12. Any condition not described in the Indications for Use. WARNINGS AND PRECAUTIONS The Acapella One Cervical Spacer System should only be implanted by surgeons who are fully experienced in the use of such implants and the required specialized spinal surgery techniques. Further, the proper selection and compliance of the patient will greatly affect the results. The surgeon should consider the patient conditions (e.g., smoker, malnutrition, obesity, alcohol and drug abuse, poor muscle and bone quality), which may impact system performance. The internal anchors must be deployed when using the Acapella One System. Autogenous bone grafting must be part of the spinal fusion procedure in which the Acapella One Cervical Spacer System is used. Use of this product without an autogenous bone graft may not be successful. The spinal implant cannot stand body loads without the support of bone. In this event, bending, loosening, disassembly and/or breakage of the device will eventually occur. The selection of the proper size, shape and design of the implant for each patient is crucial to the success of the procedure. Plastic polymer implants are subject to repeated stresses in use, and their strength is limited by the need to adapt the design to the size and shape of human bones. Unless great care is taken in patient selection, proper placement of the implant, and postoperative management to minimize stresses on the implant, such stresses may cause material fatigue and consequent breakage, bending or loosening of the device before the healing process is complete, which may result in further injury or the need to remove the device prematurely. Exactech, Inc. is proud to have offices and distributors around the globe. For more information about Exactech products available in your country, please visit www.exactechspine.com For additional device information, refer to the Exactech Spine Instructions for Use for a device description, indications, contraindications, precautions and warnings. For further product information, please contact Customer Service, Exactech 2320 NW 66th Court, Gainesville, Florida 32653-1630, USA. (352) 377-1140, (800) 392-2832 or FAX (352) 378-2617. Exactech, Inc. as the manufacturer of this device, does not practice medicine, and is not responsible for recommending the appropriate surgical technique for use on a particular patient. These guidelines are intended to be solely informational and each surgeon must evaluate the appropriateness of these guidelines based on his or her personal medical training and experience. Prior to use of this system, the surgeon should refer to the product package insert for comprehensive warnings, precautions, indications for use, contraindications and adverse effects. The products discussed herein may be available under different trademarks in different countries. All copyrights, and pending and registered trademarks, are property of Exactech, Inc. This material is intended for the sole use and benefit of the Exactech sales force and physicians. It should not be redistributed, duplicated or disclosed without the express written consent of Exactech, Inc. 352-377-1140 1-800-EXACTECH www.exactechspine.com 2016 Exactech, Inc. 716-14-30 Rev. A 0616