INDEPENDENCE MIS Anterior Lumbar Interbody Fusion System

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At Globus, we move with a sense of urgency to deliver innovations that improve the quality of life for patients with spinal disorders. We are inspired by the needs of these patients and also the needs of the surgeons and health care providers who treat them.

the techniques and outcomes of spine surgery so patients can resume their lives as quickly as possible. We extend our reach beyond our world class implants, instrumentation, and service by partnering with researchers and educators to advance the science and knowledge of spine care.

This passion combined with Globus’ world class engineering transforms clinical insights into tangible spine care solutions. We are driven to provide the highest quality products to improve

The energy and enthusiasm each of us bring everyday to Globus is palpable. We are constantly in the pursuit of better patient care and understand that speed is critical because life cannot wait.

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INDEPENDENCE MIS Anterior Lumbar Interbody Fusion System

®

INDEPENDENCE MIS® is an integrated lumbar plate-spacer designed to deliver anchor fixation in fewer procedural steps through a less invasive surgical corridor than traditional integrated spacers.

INDEPENDENCE INDEPENDENCE MIS MIS®® ALIF ALIF System System || 11

INDEPENDENCE MIS

®

ANTERIOR LUMBAR INTERBODY FUSION SYSTEM

Confident Blocking Helps prevent screw and anchor backout

Anchor Design Provides purchase and strength

Staggered Fixation Position Eliminates interference with adjacent level implant Intraoperative Versatility Allows for screws or anchors

 In-line Integrated Fixation Innovative instruments facilitate simple implantation even with challenging patient anatomy.

 Biomechanical Stability Biomechanically comparable with a traditional stand-alone ALIF system when used with screws.

 Intraoperative Versatility Compatible with anchors and screws, providing multiple options for securing the spacer to the vertebral bodies.

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CONTENTS Implant Overview Instrument Overview Surgical Technique 1. Approach 2. Preparation 3. Implant Sizing Use with Anchors 4. Anchor Loading 5. Spacer Insertion 6. Anchor Insertion 7. Anchor Blocking 8. Final Position Use with Screws 4. Spacer Insertion 5. Screw Hole Preparation 6. Screw Insertion 7. Screw Blocking 8. Final Position Use with Hybrid Screw/Anchor Fixation 9. Final Position 10. Supplemental Fixation Optional: Removal Angled Instrument Assembly Additional Specifications INDEPENDENCE MIS® Implant Sets Lumbar Anchor Set ALIF Bone Screw Set INDEPENDENCE MIS® Trial Set INDEPENDENCE MIS® 20° Set INDEPENDENCE MIS® 25° Set INDEPENDENCE MIS® 30° Set INDEPENDENCE MIS® Instrument Set ALIF Instrument Set Anterior Disc Prep I Set Anterior Disc Prep II Set INDEPENDENCE® Anterior Bone Screw Set Important Information

4 5 10 11 11 12 13 14 15 15 16 17 18 19 19 20 20 20 21 23 25 28 30 32 34 36 38 39 40 42 44 46 48 50

The Surgical Technique shown is for illustrative purposes only. The technique(s) actually employed in each case always depends on the medical judgment of the surgeon exercised before and during surgery as to the best mode of treatment for each patient. Additionally, as instruments may occasionally be updated, the instruments depicted in this Surgical Technique may not be exactly the same as the instruments currently available. Please consult with your sales representative or contact Globus directly for more information. INDEPENDENCE MIS® ALIF System | 3

IMPLANT OVERVIEW Spacer Options • Three axial footprints: 24x30, 26x34, 29x39mm • Six heights: 11, 13, 15, 17, 19, 21mm • Three sagittal profiles: 8°, 15°, 20°*, 25°*, 30°*

29mm

26mm

24mm

39mm

34mm

30mm

Fixation Options Lumbar Anchor Options • Four anchor lengths: 20*, 25, 27, and 30mm • 5.5mm diameter

Lumbar Anchor

Screw Options

Variable Angle Self-Tapping Screw

• Fixed and variable angle screws (±5)

Variable Angle Self-Drilling Screw

HA Coated Variable Angle Screw

• Five screw lengths: 20, 25, 30, 35, 40mm • 5.5mm diameter • Self-tapping, self-drilling* • Hydroxyapatite (HA) coated*

Fixation Angulation • 35° cephalad/caudal orientation • 0° medial divergence • Variable angle offers 5° conical angulation

35°

35°

35°

35° 0°

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0°

*Additionally Available

INSTRUMENT OVERVIEW Trials Small (24x30mm) Angle

11mm

13mm

15mm

17mm

19mm

21mm

8°

676.111

676.113

676.115

676.117

–

–

15°

676.211

676.213

676.215

676.217

–

–

20°*

–

676.233

676.235

676.237

–

–

25°*

–

–

676.315

676.317

676.319

676.321

30°*

–

–

676.355

676.357

676.359

676.361

Angle

11mm

13mm

15mm

17mm

19mm

21mm

8°

676.411

676.413

676.415

676.417

676.419

676.421

15°

676.511

676.513

676.515

676.517

676.519

676.521

20°*

–

676.533

676.535

676.537

676.539

676.541

25°*

–

–

676.615

676.617

676.619

676.621

30°*

–

–

–

676.667

676.669

676.671

Medium (26x34mm)

Large (29x39mm)* Angle

11mm

13mm

15mm

17mm

19mm

21mm

23mm

25mm

8°

676.711

676.713

676.715

676.717

676.719

676.721

–

–

15°

–

676.813

676.815

676.817

676.819

676.821

–

–

20°*

–

–

676.835

676.837

676.839

676.841

–

–

25°*

–

–

–

676.917

676.919

676.921

–

–

30°*

–

–

–

–

–

676.991

676.993

676.995

Trial Holders*

Trial Holder 6108.0003

Trial Sleeve 6108.0001

Trial Holder Assembly

*Available in the ALIF Instrument Set (925.905)

INDEPENDENCE MIS® ALIF System | 5

Implant Insertion Instruments

Triple Barrel Anchor Guides Size

Part Number

11mm

6135.0011

13mm

6135.0013

15mm

6135.0015

17mm

6135.0017

19mm

6135.0019

21mm

6135.0021

Threaded Rod 6135.0010

Anchor Impactor 6135.0001

Hex Driver 6135.0050

Freehold Holder 6135.0100

Hammer 603.977 6 |

Straight Instruments*

QC Handle, Small with Cap 650.105

3.5mm Hex Straight Driver 676.502

QC Handle with Cap 650.105 3.5mm Hex Straight Driver 676.502 (Assembled)

Self-Centering Straight Instruments with Retracting Front Sleeve**

Self-Centering Straight Drill 676.704**

Self-Centering Straight Awl 676.706**

Self-Centering Straight Instruments (Assembled)

5.5mm Straight Tap 676.708*

Set Screw Positioner, Torque Limiting (0.4Nm) 6108.1006

*Available in ALIF Instrument Set **Drill, awl and tap dimensions can be found on page 28

INDEPENDENCE MIS® ALIF System | 7

Angled Instruments*

Counter Torque 676.699

Angled Sleeve 676.700

Shaft 676.701

Nut 676.702

Self-Centering Bent Awl 676.705

Self-Centering Angled Drill 676.703**

5.5mm Angled Tap 676.707**

3.5mm Angled Hex Driver, Long 676.809

3.5mm Angled Hex Driver, Short 676.710

Angled Driver Body 676.700 Angled Driver Shaft 676.701 Angled Driver Nut 676.702 3.5mm Angled Hex Driver, Short 676.710 (Assembled) 8 |

*Available in ALIF Instrument Set **Drill, awl and tap dimensions can be found on page 28

Removal Instruments

Removal Tool (Disposable) 6135.0500

Slide Hammer 614.802

INDEPENDENCE MIS® ALIF System | 9

INDEPENDENCE MIS® SURGICAL TECHNIQUE Step 1 Approach Advances in minimally invasive surgery, in particular instrumentation and retractor systems, such as MARS™ Anterior, have allowed surgeons to utilize mini-open anterior retroperitoneal approaches. Without compromising surgical goals, minimally invasive surgery has been shown1,2 to: • Reduce trauma and soft tissue disruption • Reduce scarring • Shorten hospital stay

• Reduce blood loss • Reduce postoperative pain • Shorten recovery time

An anterior approach is used to implant the INDEPENDENCE MIS® Spacer. Insertion can be accomplished through a minimally invasive surgical approach. A standard mini-open anterior approach is shown. The patient is placed in the supine position, and access to the disc space is created.

1. Lee SH, Choi WG, Lim SR, Kand HY. Minimally invasive anterior lumbar fusion followed by percutaneous pedicle screw fixation for isthmic spondylolisthesis. Spine J. 2004;4(6):664-669. 2. Kim KT, Lee SH, Suk KS, Bae SC. The quantitative analysis of tissue injury markers after mini-open lumbar fusion. Spine (Phila Pa 1976). 2006;31(6):712-716. 10 |

Step 2 Preparation Anterior Disc Preparation instruments may be used to expose the disc and remove the disc materials with rongeurs and other suitable instruments. Scrapers may be used to remove superficial layers of the cartilaginous endplates. The posterior and lateral walls of the annulus should be preserved to provide peripheral support.

3 Step

Implant Sizing

Select an appropriately sized Trial and attach it to the Trial Holder Assembly. Insert the Trial into the disc space, as shown on the right. Determine which Trial best fits the prepared disc space. A secure fit is desirable to maintain disc height and stabilize the segment, and can be confirmed by fluoroscopy and tactile feel.

Using the Trial Holder Ensure that the Trial Holder Assembly is in the unlocked position. Thread the Trial onto the holder by rotating the handle clockwise. Lock the holder by pressing the release button and compressing the lock forward. To disengage, pull the locking sleeves back and rotate the handle counterclockwise.

Locked

Unlocked

INDEPENDENCE MIS® ALIF System | 11

INDEPENDENCE MIS® may be used with three anchors, three screws, or any combination of screws and anchors. • Use with Anchors: Follow steps 4-8 on pages 12-15. • Use with Screws: Follow steps 4-8 on pages 16-19. •  Hybrid use with Anchors and Screws: For anchor fixation follow steps 4-8 on pages 12-15. For screw fixation follow steps 4-8 on pages 16-19.

Use with Anchors 4 Step

Anchor Loading

After determining the appropriately sized spacer, choose the corresponding Triple Barrel Anchor Guide. Select the desired anchor using the sizing chart on page 26. Load the selected anchors into the guide.

Loading the Anchors Align the anchor with the slot at the distal end of the Triple Barrel Anchor Guide. Push the anchor into the slot using a finger until a tactile and audible click is achieved. Repeat for the two remaining anchors. Confirm that anchors are fully seated before loading the spacer.

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Step 5

Spacer Insertion

Select an appropriately sized INDEPENDENCE MIS® Spacer and pack with bone graft material (autogenous and/or allogenic bone graft composed of cancellous and/or cortical cancellous bone graft material). Attach the spacer to the Triple Barrel Anchor Guide. Insert the spacer into the prepared disc space. The Hammer may be used to gently position the spacer within the disc space. The spacer should sit flush or recessed 1mm within the anterior portion of the vertebral bodies. Note: If using a spacer height of 23mm or greater, the Freehand Holder must be used for implant insertion.

Loading the Spacer

Hook hole

Threaded hole

To assemble the Triple Barrel Anchor Guide, insert the Threaded Rod into the small round hole at the proximal end. Insert the Hex Driver into the same hole to engage the Threaded Rod. Rotate the driver clockwise until the end of the Threaded Rod emerges from the distal end of the guide.

Threaded rod

Hex Driver Hook

To attach the spacer, connect the hook to the spacer’s hook hole. Align the Threaded Rod tip into the spacer’s threaded hole. Using the Hex Driver, rotate the Threaded Rod clockwise to secure the spacer.

INDEPENDENCE MIS® ALIF System | 13

Use with Anchors (cont’d) 6 Step

Anchor Insertion

Confirm that the anterior face of the spacer is flush or recessed 1mm within the anterior portion of the vertebral body. Insert the medial Anchor Impactor. Gently tamp the impactor with the Hammer until the rectangular portion of the impactor is flat against the holder. Repeat for the two lateral anchors.

Ensure all impactors are flush with the holder

Inserting the Anchor Impactor Insert an Anchor Impactor into the hole at the proximal end of the Triple Barrel Anchor Guide. Press down to advance the anchor to the vertebral endplate. Gently impact with the Hammer to advance each anchor into the vertebral body. Please note that the two lateral impactors sit 0.5mm lower than the center impactor.

Inserting the first anchor

Inserting the remaining anchors

Disengaging the Anchor Guide Following spacer and anchor insertion, remove the guide. To release the spacer, rotate the Threaded Rod counterclockwise using the Hex Driver. Gently rock the guide medial/lateral to release.

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7 Step

Anchor Blocking

Once the anchors are fully seated, insert the Set Screw Positioner, Torque Limiting into the blocking set screw and rotate clockwise approximately 90° to the final position (blocked). The positioner provides audible, visual, and tactile confirmation that the screw is blocked.

Initial Position

8 Step

Final Position (Blocked)

Final Position

The final implant position is shown below. Supplemental fixation (e.g. facet screws or posterior fixation) is required when the INDEPENDENCE MIS® Spacer is used with anchors (see Step 9, page 20).

INDEPENDENCE MIS® with Anchors

INDEPENDENCE MIS® ALIF System | 15

Use with Screws 4 Step

Spacer Insertion

Select an appropriately sized INDEPENDENCE MIS® spacer and pack with autogenous bone graft material. Attach the spacer to the Freehand Holder. Insert the spacer into the prepared disc space. A Hammer may be used to gently position the spacer within the disc space. The spacer should sit flush or recessed 1mm within the anterior portion of the vertebral bodies.

Loading the Freehand Holder To assemble the Freehand Holder, insert the Threaded Rod into the hole at the proximal end of the holder. Insert the Hex Driver into the hole at the proximal end of the holder. Engage the Threaded Rod and rotate the driver clockwise until the end of the rod emerges from the distal end of the holder. Threaded rod

Hex Driver Hook

To attach the spacer, connect the hook on the holder into the spacer’s hook hole. Align the Threaded Rod tip into the spacer’s threaded hole. Using the Hex Driver, rotate the Threaded Rod clockwise to secure the spacer.

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5 Step

Screw Hole Preparation

Insert a Self-Centering Awl to break the cortex. A Self-Centering Drill and Tap may be used to further prepare the screw hole. Fixed angle screws are used with self-centering instruments, while variable angle screws can be inserted freehand. Angled instrument assembly instructions are available on pages 23–24.

Using the Self-Centering Instruments Self-centering awls (bent and straight) and drills are available for screw trajectories of 35° cephalad/caudal. Insert a self-centering awl to break the cortex. A self-centering drill and tap may be used to further prepare the screw hole. Depending on the angle and position, a straight or angled instrument can be used.

Freehand inserter

Self-Centering Bent Awl with Retracting Front Sleeve

Aligning the Self-Centering Sleeve The self-centering sleeve ensures proper screw trajectory without use of a drill guide. The sleeve must be properly engaged with the plate before advancing any screw hole preparation instruments. Proceed to screw insertion before preparing the remaining hole.

INDEPENDENCE MIS® ALIF System | 17

Use with Screws (cont’d) 6 Step

Screw Insertion

Depending on the angle and position of the spacer, a Straight or Angled Driver may be used. If drilling is preferred, determine the desired drill depth and select the appropriate fixed length drill. Insert the drill into the screw hole and drill to the stop. Select the desired screw size using the sizing chart on page 27. Load the screw onto the driver and insert the screw. The spacer lags to the bone during screw insertion. Repeat for the second screw. Note: If inserting screws with the Freehand Holder attached, the 3.5mm Angled Hex Driver, Long will need to be used.

Disengaging the Freehand Holder Remove the Freehold Holder after spacer and screw insertion. To release the spacer, rotate the Threaded Rod counterclockwise using the Hex Driver. Gently rock the inserter medial/lateral to release.

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