FRA Spacer Instruments. For anterior lumbar interbody fusion (ALIF) using straight anterior or anterolateral approach.

Transcription

1 FRA Spacer Instruments. For anterior lumbar interbody fusion (ALIF) using straight anterior or anterolateral approach. Technique Guide Instruments and implants approved by the AO Foundation

2 Table of Contents Introduction FRA Spacer Instruments 2 Surgical Technique Planning and Preparation 3 Straight Anterior Approach 4 Anterolateral Approach (30 Offset) 8 Product Information Instruments 10 Set List 13 Synthes Spine

3 FRA Spacer Instruments The FRA Spacer instruments are designed for use with the FRA Spacer for anterior lumbar interbody fusion (ALIF) using a straight anterior or anterolateral approach. Anterior approach The FRA Spacer instruments can be used in an ALIF procedure using a straight anterior approach to the lumbar spine. The illustration depicts an FRA Spacer being implanted at the L5 S1 junction. Anterolateral approach The FRA Spacer instruments can also be used in an ALIF procedure using an anterolateral approach, or 30 offset from straight anterior. The illustration depicts an FRA Spacer being implanted at the L4 L5 junction. 2 Synthes Spine FRA Spacer Instruments

4 Planning and Preparation 1 Determine surgical approach (anterior or anterolateral) The surgical approach, which is based on the surgeon s preference, determines the implant type. 2 Determine implant height and depth (narrow or broad) Instrument 8051 FRA Preoperative Planner mm Narrow 1 0 Inches SYNTHES Spine 1690 Russell Road, Paoli, PA To order: FRA Spacer Preoperative Planner Actual Size FRA1 FRA3 FRA5 11 mm 13 mm 15 mm NARROW AP DEPTH 23 mm Min ANTERIOR HEIGHT FRA7 FRA9 FRA11 25 mm Min 29 mm Max The FRA Preoperative Planner is designed as an aid to the preoperative planning process. Determine implant depth by comparing an axial view of the radiographic FRA Preoperative Planner with the MRI, CT scan, or x-ray of the adjacent vertebral body. Broad ANTERIOR HEIGHT 17 mm 19 mm 21 mm FRA2 FRA4 FRA6 11 mm 13 mm 15 mm FRA8 FRA10 FRA12 29 mm Min 27 mm Max BROAD AP DEPTH 27 mm Min 32 mm Max Determine implant height by comparing a lateral view on the radiographic FRA Preoperative Planner with the adjacent intervertebral discs on a lateral radiograph. 100 % actual size 17 mm 19 mm 21 mm NOTE: Please specify approach (for corresponding insertion slots), e.g. FRA 1A for anterior and FRA 1A L for anterolateral. 30 mm Max GP0952-B 4/99 J2558 The implant must be seated firmly with a tight fit between the endplates when the segment is fully distracted. It is essential to use the tallest possible implant to maximize stability. Due to variability in the degrees of magnification, the templates are only an estimate and may not always provide an exact implant measurement. Synthes Spine 3

5 Straight Anterior Approach 1 Expose the disc and prepare the endplate Expose the midline of the intervertebral disc so that the center of the implant will sit on the vertebral midline. Remove only enough disc and anterior longitudinal ligament to allow the spacer to fit properly. Note: Remove the superficial layers of the cartilaginous endplates to expose bleeding bone. Adequate preparation of the endplates is important to facilitate vascular supply to the bone graft. Excessive cleaning, however, may weaken the endplate due to removal of bone underlying the cartilaginous layers. 2 Distract Instruments Curved Distractor FRA Distractor Blades , , FRA Distractor Distracting the segment is essential to restore disc height, open the neural foramen, and stabilize the implant. Distract the disc space using the assembly of the FRA Distractor and the appropriate FRA Distractor Blades, or the Curved Distractor. Place the blades of the distractor into the disc space. To ensure that the implant is inserted symmetrically in the disc space, align the etched line on the distractor blade with the anterior midline of the vertebral bodies. 4 Synthes Spine FRA Spacer Instruments

6 3 Determine implant size Instruments FRA Trial Spacers, anterior Trial Spacer Handle or Once the desired level of distraction is achieved, determine the implant size using the FRA Trial Spacers. Select the anterior FRA Trial Spacer that corresponds to the implant size determined during preoperative planning, and thread it onto the Trial Spacer Handle. Slide the anterior FRA Trial Spacer between the distractor blades and into the disc space. If the chosen trial spacer is too small, use incrementally larger trial spacers until a tight fit is achieved.* With the segment fully distracted, the FRA Trial Spacer must fit firmly with a tight fit between the endplates to ensure that disc height is not lost once the distractor is removed. It is essential to use the largest possible implant (height and depth) to maximize segment stability. Note: Ensure the distractor is held firmly in place while using the FRA Trial Spacers. Select the implant corresponding to the correct trial spacer. Distraction can then be temporarily relaxed. *If the chosen trial spacer is too large, smaller trial spacers should be used to achieve the proper fit. Synthes Spine 5

7 Straight Anterior Approach continued 4 Insert implant Instrument Implant Holder, slot Pack bone graft material into the hole of the implant. The FRA Implant Holder aligns with the pre-formed slots on the implant for easy insertion. Tighten the locking screw on the Implant Holder to ensure that the jaws of the instrument are secure against the implant. Distract the segment again and hold the distraction by tightening the locking screw on the handle of the distractor. Introduce the implant into the exposed disc space between the distractor blades. The implant should be inserted as far as possible or until the tip of the jaws of the FRA Implant Holder connect with the distractor blades (at least 2/3 of implant depth). 6 Synthes Spine FRA Spacer Instruments

8 Instrument Impactor, crescent Release the FRA Implant Holder by loosening the locking screw, and withdraw the instrument. Final seating of the implant is done with gentle blows of the crescent Impactor while maintaining the position of the distractor. Important: Before use, ensure that the impactor fits flush against the implant. Do not forcibly strike the impactor when tapping the implant into position as this may cause the implant to break. Finally, loosen the locking screw on the distractor handle, release the distraction, and remove the distractor. Synthes Spine 7

9 Anterolateral Approach (30 Offset) 1 Expose disc and prepare endplate For anterolateral insertion, the center of the implant will sit 30 offset to the anterior vertebral midline. Remove disc and prepare endplate according to Step 1 of the Straight Anterior Approach (see page 4). 2 Distract and size Instruments Curved Distractor Trial Spacer Handle, angled FRA Trial Spacers, anterolateral Distraction of the segment is essential to restore the disc height, open the neural foramen, and stabilize the implant. Distract prior to insertion of the implant using the distractor. Once the desired level of distraction is achieved, determine the correct implant size using the FRA Trial Spacers. Select the anterolateral FRA Trial Spacer that corresponds with the implant size determined during preoperative planning and thread it onto the Trial Spacer Handle. Continue with insertion of the anterolateral FRA Trial Spacers and determine the correct implant height as described in Step 3 of the Straight Anterior Approach (see page 5). 8 Synthes Spine FRA Spacer Instruments

10 3 Insert implant Insert the implant according to Step 4 of the Straight Anterior Approach (see pages 6 7). Synthes Spine 9

11 Instruments Curved Distractor Modified profile to clear patient vasculature Fixed-blade design Trial Spacer Handle, angled Attaches to the FRA Trial Spacer to permit accurate implant sizing Angled end allows easier access to L5 S1 by accommodating patient anatomy Angled Impactor, crescent Seats the FRA Spacer in the disc space Designed with curved, cross-hatch contact area to prevent slipping during impaction Angled tip allows easier access to L5 S1 by accommodating patient anatomy Implant Holder, angled Securely grips the FRA Spacer Angled tip allows easier access to L5 S1 by accommodating patient anatomy FRA Implant Holder Securely grips the FRA Spacer Allows maximum control during implant insertion FRA Distractor Multiple blade options angled and straight Accommodates varied length blades to address patient anatomy and access, including an angled approach to L5 S1 10 Synthes Spine FRA Spacer Instruments

12 Impactor, crescent Seats the FRA Spacer in the disc space Curved, cross-hatch contact area to prevent slipping during impaction Trial Spacer Handle Connects with FRA Trial Spacer to permit implant sizing Allows easy intraoperative detachment of trial spacer from handle FRA Distractor Blades mm, right mm, left mm, right mm, left mm, right mm, left angled, right angled, left mm, left mm, right , mm 45 mm 50 mm 55 mm FRA Trial Spacers, anterior FRA 1A, 11 mm, narrow FRA 2A, 11 mm, broad FRA 3A, 13 mm, narrow FRA 4A, 13 mm, broad FRA 5A, 15 mm, narrow FRA 6A, 15 mm, broad FRA 7A, 17 mm, narrow FRA 8A, 17 mm, broad FRA 9A, 19 mm, narrow FRA 11A, 21 mm, narrow FRA 10A, 19 mm, broad FRA 12A, 21 mm, broad Synthes Spine 11

13 GP0952-B 4/99 J2558 Instruments continued FRA Trial Spacers, anterolateral FRA 1A-L, 11 mm, narrow FRA 2A-L, 11 mm, broad FRA 3A-L, 13 mm, narrow FRA 4A-L, 13 mm, broad FRA 5A-L, 15 mm, narrow FRA 6A-L, 15 mm, broad FRA 7A-L, 17 mm, narrow FRA 8A-L, 17 mm, broad FRA 9A-L, 19 mm, narrow FRA 11A-L, 21 mm, narrow FRA 10A-L, 19 mm, broad FRA 12A-L, 21 mm, broad FRA Sizers FRA 1/2 Sizer, 11 mm FRA 3/4 Sizer, 13 mm FRA 5/6 Sizer, 15 mm FRA 7/8 Sizer, 17 mm FRA 9/10 Sizer, 19 mm FRA 11/12 Sizer, 21 mm 8051 FRA Preoperative Planner 40 SYNTHES Spine mm Narrow 1 0 Inches 1690 Russell Road, Paoli, PA To order: FRA Spacer Preoperative Planner Actual Size FRA1 FRA3 FRA5 NARROW AP DEPTH 23 mm Min 11 mm 13 mm 15 mm ANTERIOR HEIGHT FRA7 FRA9 FRA11 25 mm Min 29 mm Max 17 mm 19 mm 21 mm 27 mm Max Broad FRA2 FRA4 FRA6 11 mm 13 mm 15 mm BROAD AP DEPTH 27 mm Min ANTERIOR HEIGHT FRA8 FRA10 FRA12 29 mm Min 32 mm Max 17 mm 19 mm 21 mm 100 % actual size NOTE: Please specify approach (for corresponding insertion slots), e.g. FRA 1A for anterior and FRA 1A L for anterolateral. 30 mm Max 12 Synthes Spine FRA Spacer Instruments

14 FRA Spacer Instrument Set ( ) Graphic Case FRA Spacer Instrument Set Graphic Case Instruments Curved Distractor Trial Spacer Handle, angled Angled Impactor, crescent, 9 mm x 20 mm head Implant Holder, angled FRA Implant Holder FRA Distractor Impactor, crescent, 9 mm x 20 mm head Trial Spacer Handle, 2 ea FRA Preoperative Planner FRA Distractor Blades mm, right mm, left mm, right mm, left mm, right mm, left angled, right angled, left mm, left mm, right FRA Trial Spacers, anterior FRA 1A, 11 mm, narrow FRA 2A, 11 mm, broad FRA 3A, 13 mm, narrow FRA 4A, 13 mm, broad FRA 5A, 15 mm, narrow FRA 6A, 15 mm, broad FRA 7A, 17 mm, narrow FRA 8A, 17 mm, broad FRA 9A, 19 mm, narrow FRA 11A, 21 mm, narrow FRA 10A, 19 mm, broad FRA 12A, 21 mm, broad Anterior FRA Trial Spacer, anterolateral FRA 1A-L, 11 mm, narrow FRA 2A-L, 11 mm, broad FRA 3A-L, 13 mm, narrow FRA 4A-L, 13 mm, broad FRA 5A-L, 15 mm, narrow FRA 6A-L, 15 mm, broad FRA 7A-L, 17 mm, narrow FRA 8A-L, 17 mm, broad FRA 9A-L, 19 mm, narrow FRA 11A-L, 21 mm, narrow FRA 10A-L, 19 mm, broad FRA 12A-L, 21 mm, broad FRA Sizers FRA 1/2 Sizer, 11 mm FRA 3/4 Sizer, 13 mm FRA 5/6 Sizer, 15 mm FRA 7/8 Sizer, 17 mm FRA 9/10 Sizer, 19 mm FRA 11/12 Sizer, 21 mm Anterolateral Synthes Spine 13

15 Synthes Spine 1302 Wrights Lane East West Chester, PA Telephone: (610) To order: (800) Fax: (610) Synthes, Inc. or its affiliates. All rights reserved. Synthes is a trademark of Synthes, Inc. or its affiliates. Printed in U.S.A. 3/07 J2995-E