bnjs 795 nexus st2 - zimmer biomet15 productinformation implants catalog# nexusimplants 1000-3000...

Surgical Technique

Contents

Introduction ........................................................ 1

System Design Features ...................................... 2

Instruments ........................................................ 3

Surgical Technique .............................................. 5

Indications For Use ............................................ 14

Product Information ............................................ 15

Further Information ............................................ 16

Introduction

1

The Nexus Spacer utilizes a curved, open, three-dimensional

design, matching the anatomical shape of the anterior column

and enabling placement such that compressive loads are

focused on the strongest portion of the endplate may help

resist subsidence. Fusions can infiltrate porous implant walls

in all directions, encouraging a comprehensive fusion.

The instrumentation and spacers are designed so that

endplates can be preserved, reducing a surgical step since

the endplates do not need to be cut or reamed. The implant’s

superior/inferior surfaces engage the bony endplates, to help

resist sheer and rotational forces.

The Nexus Spine System offers an array of instruments

that are simple and intuitive to use. Implants and instruments

are color-coded to provide easy identification when

determining the appropriate implant size intraoperatively.

Sleek curved, straight, and angled pushers facilitate proper

placement on the endplate’s strongest cortical bone, while

enabling visualization of implant manipulation.

The Nexus Spacer is indicated for use in the thoracolumbar

spine (i.e., T1 to L5) to replace 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. The Nexus Spacer is also indicated for

treating fractures of the thoracic and lumbar spine.

The Nexus™ Spinal System is designed to restore the

biomechanical integrity of the anterior, middle and posterior

spinal column even in the absence of fusion for a

prolonged period.

Product Overview

The Nexus Spacer was designed with the objective of

providing a stable environment for a fusion to take place.

To accomplish this, the spacer is constructed of titanium

monofilaments. This novel application of cast titanium into

small strands of metal allows a design that minimizes metal

content, enabling maximal bone graft material volume and

surface area.

The monofilaments form three-dimensional tetrahedrons,

utilizing the same structural support originally devised by

Buckminster Fuller for innovative architectural designs. By

decreasing the amount of metal required to provide strong

structural support, radiographic interference with fusion

confirmation is minimized. The titanium-reduced construction

also significantly increases the bone graft packing volume

within the spacer.

Biomet engineers have taken the design of the Nexus Spacer

one step further, however, by contouring the filaments to

provide excellent endplate contact. This greater surface area

contact with the endplates, helps to minimize subsidence by

disbursing loads across a broader cross-section of the

cortical endplate, while providing openings through which

vascularization can take place.

System Design Features

Unique Monofilament Cast Titanium Design

• Minimizes Titanium to enable:

- Radiographic visualization and assessment of thefusion progression

- Optimized bone graft packing volume

- Balanced design with maximum surface contact whileproviding vascularization

- Highly stable structure with excellent endplate coverage

2

Implant lengths available in 22mmand 28mm

Heights measured from themiddle of implant and availablefrom 9mm to 15mm

Open Design

• Enables bony infiltration throughout the fusion site

• Lack of solid walls provides stable environment forcomprehensive bone growth in all three dimensions

Endplate Sparing

• Preserving endplate resists subsidence

• Reduces a surgical step by eliminating endplate cuttingand reaming

Available In A Wide Range Of Sizes

Trials are .5mm undersized to ensure a proper implant fit

Implantwidthsavailable in9mm and11mm

Instruments

3

Trial Handle

Slap Hammer

Nerve Root Retractors

Bone Mold

Paddle Scrapers

Paddle Scraper Handle

Slotted Hammer

Trial

4

Instruments (Continued)

Removal Hook Tool

Tamp

Pusher

Inserter

Bone Mold Base

Curved Pusher

Straight Pusher

Angled Pusher

Surgical Technique

1. Nerve Root Retraction

The Dura Retractor and Nerve Root Retractor (Figure 1) can

be used to carefully retract the nerve roots during surgery.

A Left and a Right oriented Retractor are included in the

Nexus System. The Retractor blades (Figure 2) have a length

of 13mm and a width of 9mm.

A standard surgical approach is utilized.

Discectomy instrumentation is available from the Biomet

Spine Posterior Discectomy Prep Kit System.

5

Figure 1

Figure 2

13mm

9mm

Figure 4

New In This Step:

2. Disc Space Preparation

The Paddle Scrapers (Figure 3) are used to disrupt the disk

material by rotating in the disk space. The Scrapers feature

cutting flutes which allow for cutting when rotated in both

directions. To accomplish this tissue removal, insert the

paddle into the disc space and rotate the instrument back

and forth until all disc material has been freed. Paddle

Scrapers are used with the Paddle Scraper Handles.

The Paddle Scraper Handles utilize a simple but effective

locking mechanism to securely connect to the paddle

scrapers. (Figure 4) Pull back on the enlarged throat of the

handle, while inserting the shaft of the paddle scraper. Rotate

the paddle scraper until the scraper shaft tab properly mates

with the slot in the handle. (Figure 5)

6

Surgical Technique (Continued)

Paddle Scraper Handle

Figure 3

Paddle Scrapers

Figure 5

7

3. Implant Selection

The Trials can be used to identify the desired implant while

providing distraction within the space. (Figure 6) The Trials

are color coded for easy size identification when determining

implant height of the corresponding implant. The Trials are

attached to the Trial Handle, which can be integrated with the

Slap Hammer.

The Trials are available in sizes that match the available

implants. Note that in many sizes, the Nexus Spacer is

available in two different lengths, 22mm and 28mm, and so

trials exist for two different lengths.

Trials are .5mm undersized when compared to the

Nexus Spacer.

After the appropriate Trial has been determined, select the

matching Nexus implant.

Figure 6

New In This Step:

Trial

Handle

Slap Hammer

8


3. Implant Selection (Continued)

The Nexus Trial Handle has a special Hudson Locking

quick-connect mechanism designed to attach to the Nexus

Trials. (Figure 7) When attaching the shaft of the Trial to the

Handle, (Figure 8) the following steps are recommended:

a. Rotate the outer sleeve of the Hudson quick-connect

approximately 90° counterclockwise.

b. Pull back on the enlarged throat of the handle’s outer

sleeve, while inserting the shaft of the paddle scraper.

c. Insert the shaft of the trial into the Hudson quick-

connect and rotate until the shaft tab mates with the

handle’s slot. IMPORTANT – Be sure that there is an

audible click when the shaft of the trial is fully seated

into the Hudson quick-connect mechanism. This

ensures that the trial shaft is fully engaged into the

locking mechanism. (Figure 9)

d. Release the outer sleeve of the Hudson connector and

rotate it approximately 90° clockwise to ensure that the

shaft is securely locked into the handle prior to impaction

of the trial. This ensures that in the event that the Trial

becomes lodged within the vertebral space, the Slap

Hammer Tool can be utilized for safe removal.

e. Thread the Slap Hammer into the back of the Trial

Handle. (Figure 10 & Figure 11) TIP – Always confirm

that the trial shaft is securely locked into the Hudson

quick-connect mechanism prior to striking the handle.

Figure 7

Figure 8

Figure 10

Figure 11

Rotate Trialuntil it properlymates with slotin handle

Figure 9

Tamp

4. Packing Nexus Implant

After implant selection, bone graft material should be

packed into the implant.

A tamp and pusher are provided to facilitate tight

packing of graft material into the Nexus implant prior

to implantation. These instruments are used in conjunction

with the packing molds.

9

New In This Step:

Pusher

Bone Mold And Base

4. Packing Nexus Implant (Continued)

The Implant Molds are designed to facilitate packing of

graft material into the cage prior to insertion. Molds are

available for each implant height and are to be used

with their corresponding base (22mm - Blue or 28mm -

Green). One end of the implant is used for attachment

to the Inserter instrument and the other end is wide

open to accommodate packing of bone graft material

into the implant.

To load the implant into the mold, insert the open end

of the implant into the mold cavity from the bottom

side. Insert the corresponding base to the mold. Flip

the mold over to its funneled side and load the graft

material using the tamp and pusher as desired. After

the implant is tightly packed, flip the mold back to its

bottom or non-funneled side, remove the base and

attach the Inserter to the implant. Approximately 2-5cc

of bone graft material is needed to tightly pack the

implant depending on its size.

10


New In This Step:

11

5. Implant Insertion

The Inserter rigidly attaches to the implant to provide

maximum control of the implant during insertion.

The Inserter’s lever arm, located near the Inserter’s

blue handle, should be almost perpendicular to the

shaft of the Inserter when in the open position.

Match the tabs of the Inserter to the slots on the

implant and press the Inserter into the implant.

(Figure 12) The implant locks onto the Inserter by

pushing the lever arm all the way forward, until it is

almost parallel with the Inserter shaft.

Insert the implant into the created implant channel.

(Figure 13 & Figure 14) To unlock the implant from

the Inserter, simply pull back on the lever arm and

return it to its perpendicular position.

Inserter

Lever arm shownin open position

Figure 12

Figure 13

Figure 14

New In This Step:

12


6. Final Positioning

Three pusher options are available to assist in

positioning the Nexus implant after it has been

removed from the Inserter.

a. The Curved and Straight Pushers were created for

surgeons who want to position the implant without

the use of a “rounded post” impactor.

b. The Angled Pusher has a “rounded post” at the tip

of the instrument. The tip fits into the Inserter end of

the implant. The tip is intended to provide direction

control during final placement of the implant. The

Nexus Angled Pusher features depth indicators to

indicate depth of the implant

Straight Pusher

Angled Pusher

Curved Pusher

New In This Step:

13

Closure And Postoperative Care

A routine wound closure is then performed.

• Routine monitoring of the vital signs, and of thehemodynamic and neurologic status of the patient

• Pain medication

• NG tubes and/or Foley catheters are discontinued within24 - 48 hours

• Diet is restricted to small amounts of liquids until returnof bowel function is completed

• The patient is encouraged to ambulate as soon aspossible. The individual surgeon determinesactivity level

• Braces are to be used at each surgeon's discretion

Implant Removal

Should it become necessary to remove the Nexus Spacer,

the following steps should be utilized:

1. The Hook Removal Tool should be used if the Insertercannot be reengaged on the implant.

2. Insert the tip of the hook into the opening of the Nexusinserter key.

3. Rotate the hook 90° to allow for secure engagement ofthe implant.

4. Use the Slotted Mallet to impact the plate located underthe handle of the Hook instrument until adequaterepositioning or removal is achieved.

New In This Step:

Hook Remover Tool

Indications For Use

14

The Nexus Spine System is indicated for use in the

thoracolumbar spine (i.e., T1 to L5) to replace 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. The Nexus Spine System

is also indicated for treating fractures of the thoracic and

lumbar spine. The Nexus Spine System is designed

to restore the biomechanical integrity of the anterior,

middle and posterior spinal column even in the absence

of fusion for a prolonged period.

For information on:

• Indications For Use

• Contraindications

• Precautions

• Sterilization

Please refer to the Nexus Spine System Package Insert.

CAUTION: Federal Law (USA) restricts this device to sale by

or on the order of a physician.

15

Product Information

Implants

Catalog # Nexus Implants

1000-3000 Spacer, 9 x 9 x 22mm

1000-3001 Spacer, 9 x 10 x 22mm

1000-3003 Spacer, 11 x 11 x 22mm

1000-3004 Spacer, 11 x 12 x 22mm

1000-3005 Spacer, 11 x 13 x 22mm

1000-3010 Spacer, 9 x 9 x 28mm

1000-3011 Spacer, 9 x 10 x 28mm

1000-3013 Spacer, 11 x 11 x 28mm

1000-3014 Spacer, 11 x 12 x 28mm

1000-3015 Spacer, 11 x 13 x 28mm

1000-3016 Spacer, 11 x 15 x 28mm

1000-3017 Spacer, 11 x 17 x 28mm

Instruments

Catalog # Description

1000-9051M Trial, 9 x 9 x 22mm

1000-9052M Trial, 9 x 10 x 22mm

1000-9054M Trial, 11 x 11 x 22mm

1000-9055M Trial, 11 x 12 x 22mm

1000-9056M Trial, 11 x 13 x 22mm

1000-9057M Trial, 9 x 9 x 28mm

1000-9058M Trial, 9 x 10 x 28mm

1000-9059M Trial, 11 x 11 x 28mm

1000-9060M Trial, 11 x 12 x 28mm

1000-9061M Trial, 11 x 13 x 28mm

1000-9062M Trial, 11 x 15 x 28mm

1000-9063M Trial, 11 x 17 x 28mm

1000-9065 Trial Handle

1000-9050 Slap Hammer Tool

1000-9609-1 Mold Top, Right - 9mm

1000-9609-2 Mold Top, Left - 9mm


1000-9610-2 Mold Top, Left - 10mm


Instruments (Continued)

Catalog # Description

1000-9611-2 Mold Top, Left -11mm


1000-9612-2 Mold Top, Left - 12mm


1000-9613-2 Mold Top, Left - 13mm


1000-9615-2 Mold Top, Left - 15mm


1000-9617-2 Mold Top, Left - 17mm

1000-9622 Mold Base - 22mm

1000-9628 Mold Base - 28mm

1000-9303 Curved Pusher

1000-9300 Straight Pusher

1000-9600 Angled Pusher

1000-9304 Hook Removal Tool

1000-9007 Slotted Hammer

1000-9010 Tamp

1000-9011 Pusher

1000-9014 GEO Inserter

1000-9903 Base, Lid, and Mold Insert

1000-9004 Quick Connect T-Handle Z-Style

1000-9537 Nerve Root Retractor - Right

1000-9538 Nerve Root Retractor - Left

1000-9500 9mm Paddle Scraper









Notes:The Nexus Spine System Surgical Technique is presented

to demonstrate the surgical technique utilized by Hyun Bae,

M.D. Biomet Spine, as the manufacturer of this device,

does not practice medicine and does not recommend this

product or any specific surgical technique for use on any

individual patient. The surgeon who performs any implant

procedure is responsible for determining the appropriate

product(s) and utilizing the appropriate technique(s) for

said implantation in each individual patient.

For further information, please contact the Customer

Service Department at:

Biomet Spine

100 Interpace Parkway

Parsippany, NJ 07054

(973) 299-9300 - (800) 526-2579

www.biometspine.com

Further Information

16

100 Interpace ParkwayParsippany, NJ 07054www.biometspine.com800-526-2579

All trademarks are the property of Biomet, Inc.,or one of its subsidiaries, unless otherwise indicated. Rx Only.

Copyright 2008 Biomet, Inc. All rights reserved. P/N 228024L 06/08

bnjs 795 nexus st2 - zimmer biomet15 productinformation implants catalog# nexusimplants 1000-3000...

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