NuNec®

Cervical Arthroplasty System

Surgical Technique
 TABLE OF CONTENTS

INTRODUCTION
System Overview .......................................................................................................................1

SURGICAL TECHNIQUE
Step 1 - Patient Positioning........................................................................................................2
Step 2 - Disc Access...................................................................................................................3
Step 3 - Discectomy....................................................................................................................4
Step 4 - Decompression.............................................................................................................6
Step 5 - Trial Sizing.....................................................................................................................7
Step 6 - Endplate Preparation - Drilling.....................................................................................10
Step 7 - Implantation..................................................................................................................12
Step 8 - Implant Fixation.............................................................................................................14
Step 9 - Final Placement & Closure...........................................................................................15

APPENDIX A: LOADING ALTERNATIVE............................................................................16

INDICATIONS & WARNINGS

Indications, Contraindications, Precautions, Warnings ..........................................................18
 INTRODUCTION

SYSTEM OVERVIEW
Cervical spine arthroplasty is an innovative and effective means of stabilizing the spine and offering relief of the intractable symptoms and
physiological findings associated with cervical spondylosis and radiculopathy. Anterior cervical discectomy and fusion (ACDF), though
effective in managing symptomatic relief has the disadvantage of converting the operating segment of the cervical spine into an immobile
fused unit. The most pronounced disadvantage of this treatment is the overall lack of mobility and increased risk of adjacent degenerative
disc disease.

The NuNec® Cervical Arthroplasty System is intended to preserve segmental motion, offer symptomatic relief and reduce reoperation due
to pseudoarthrosis.

PATIENT SELECTION
Proper patient selection plays a critical role in the success of cervical spine arthroplasty. The NuNec Cervical Arthroplasty System is
primarily indicated for cervical soft disc disease. Ideal candidates are patients with radiculopathy and focal disc disease. Patients with
advanced spondylotic disease, especially patients with diffuse spondylosis or significant anterior/posterior osteophytes, should not be
treated with anterior cervical arthroplasty. One potential effect of these conditions, along with individual patient anatomy, may prevent ideal
engagement of the fixation cams. If sufficient engagement is not accomplished, consideration should be made for alternate treatment as
determined appropriate by the healthcare professional.

ROTATING CAMS
for superior fixation*

RADIOLUCENT HYDROXYAPATITE COATING

to reduce radiographic artifacting for improved fixation

FLEXION/EXTENSION† LATERAL BENDING† AXIAL RANGE OF MOTION

22° to 40° Min 11° 360°

Typical 22°

*As compared to press-fit and spike style fixation systems evaluated. Data on file at RTI Surgical, Inc.
†
Varies depending on device size. Data on file at RTI Surgical, Inc.

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SURGICAL TECHNIQUE

1 PATIENT POSITIONING

Place the patient in the supine position with the head and
neck supported in a neutral position. A rolled pillow may
be placed under the neck to support and maintain proper
positioning (Figure 1). Care must be taken not to place the
neck in extension.

Note: Place the occiput in a donut to allow the head to be

elevated approximately 2.5cm (1 inch) off the table. Lateral
fluoroscopy may be used as a guide to achieve neutral positioning.
Figure 1
Pull the patient’s shoulders down and confirm the targeted
disc space with a lateral x-ray. Using an anterior/posterior
(A/P) x-ray, verify the spinous processes are midway
between the facet joints.

Once positioned, tape the patient accordingly. Head halter

traction may be applied. Both the head and torso should
remain fixed throughout the procedure.

Site Identification
Identify the location of the affected operative disc level
and corresponding incision site using A/P and lateral
fluoroscopy while marking the skin with sterile ink.

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 SURGICAL TECHNIQUE

2 DISC ACCESS

Access the disc space via a transverse skin incision

creating an avascular dissection plane between the
trachea and both the esophagus (medially) and carotid
sheath (laterally). Using fluoroscopy, ensure the skin
incision is directly overlying the index level. Enter the
platysma longitudinally along the axis of its fibers,
perpendicular to the incision, allowing for more freedom of
movement in the cephalad/caudal direction.

Figure 2
After the incision is made, retract using handheld retractors
(Figure 2), to expose the anterior vertebral column and the
adjacent longus colli muscles.

Using a self-retaining retractor system, position the

retractor blades below the longus colli muscles, creating a
symmetric exposure of the targeted disc space. Once disc
exposure is created, subperiosteally elevate the longus colli
muscles off the vertebral bodies and position the retractor
blades accordingly.

Note: Identify the midline by using the borders of the longus colli
muscles, the anterior longitudinal ligament and the natural slope
of the anterior vertebral bodies as landmarks. The vertebral body
is preliminarily marked in the midline using electrocautery or other
methods.

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SURGICAL TECHNIQUE

3 DISCECTOMY

Caspar distraction pins (Figure 3A) may be used to

facilitate posterior decompression and release, allowing
the disc space to be mobilized. Use A/P fluoroscopy
to confirm placement of the pins in the midline. The
pins should be placed in the upper half of the superior
vertebral body and the lower half of the inferior vertebral
body to ensure adequate space for trialing and final
placement. If performing multi-level arthroplasty, pins
should be placed centrally in the vertebral bodies.

Figure 3A
Verify the midline by placing distraction posts or a
localizing device in line with the spinous processes
using true A/P fluoroscopy. Equal lateral margins of the
vertebral body and uncovertebral joints confirm midline
(Figure 3B).

Complete a discectomy (Figure 3C) in the standard

fashion with curettes and pituitary rongeurs. Following
discectomy, complete a thorough and symmetric
decompression.

Figure 3B

Figure 3C

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 SURGICAL TECHNIQUE

Use a high-speed burr to remove the cartilaginous

endplates, preserving the bony endplates. Exposure of
the cancellous bone can predispose it to heterotopic
ossification and subsidence. Therefore, use of the
drill should be minimized and any drilling should
be accompanied by copious irrigation followed by
placement of bone wax over exposed cancellous bone.

Resect the proximal uncovertebral joints bilaterally and

equally until proximal foraminotomies are completed.
Bilateral decompression and relatively flat endplates
are crucial to allow for proper sizing, fit and midline
placement of the implant. Short-term stability is
dependent on proper sizing and fit in the interbody
space.

CAUTION: Avoid over-distraction with the vertebral distractor to

prevent nerve root tension or improper implant selection. Over-
distraction is considered distraction of the index level to a height
greater than that of the patient’s nominal healthy condition. This
may be assessed by evaluation of the adjacent facet joint spacing
as compared to that of the indexed level.

CAUTION: Avoid excessive endplate removal to decrease the

potential risk of implant subsidence.

CAUTION: Proper endplate removal is considered to be

removal of the cartilagenous tissue and cortical bone sufficient
for complete contact with the implant only. Cartilagenous tissue
must be removed from the endplates as its presence may reduce
fixation strength.

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SURGICAL TECHNIQUE

4 DECOMPRESSION

Decompression includes resection of the posterior

longitudinal ligament (PLL) (Figure 4) to expose the dura
and proximal nerve roots bilaterally. Remove posterior
osteophytes and hypertrophied uncal spurs using Kerrison
rongeurs and curettes and/or a high-speed drill. Mobilize
the disc space with a complete posterior release; failure to
do so will limit the motion of the disc and may predispose
it to anterior displacement.

IMPORTANT: Keep the vertebral endplates parallel to one another

with both the superior and inferior endplates angled downward. Figure 4
Care must be taken to maintain this natural orientation of the
vertebral endplates.

IMPORTANT: Remove anterior osteophytes to ensure correct

sizing with instruments and implants.

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 SURGICAL TECHNIQUE

Footprint Implant Depth (A/P) Implant Width (Lateral)

5 TRIAL SIZING
Small 12mm 14mm
Footprint Sizing Small Deep 14.5mm 14mm
Footprints are used to determine proper implant depth Medium 14.5mm 17mm
(A/P) and width (lateral) (Figures 5A and 5B). The goal is to Medium Deep 17mm 17mm
maximize vertebral endplate coverage in order to minimize Table 1 - Footprint Sizing
subsidence and the potential risk of malpositioning.

Under retraction, place the footprint sizer into the prepared

disc space to determine implant dimensions (Table 1).
Each footprint sizer is color coordinated to match the drills,
trial spacers and implant cams of the same size implant.

Surgical Tip: Start trialing with the smallest footprint and proceed
INCORRECT
to the next larger size until an appropriate footprint is determined.

The footprint sizer should fit snugly in the disc space.

Confirm via lateral fluoroscopy (Figure 5A).

Note: Insert the footprint sizer at an angle parallel to the inferior

vertebral endplate (Figure 5A).

Trial Spacer Sizing CORRECT DEPTH

Once a footprint size is determined, remove the distraction
system (leaving pins in place) and begin trialing with the Figure 5A

trial spacers to determine proper implant height.

Note: Trial spacers should match the color of the selected

footprint sizer and be oriented with two superior drilling channels
and one inferior channel.

INCORRECT

CORRECT WIDTH

Figure 5B

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SURGICAL TECHNIQUE

Trial Spacer/Inserter Assembly

Squeeze the handle of the trial inserter and place its
leading edge into the bottom hole of the appropriate trial
spacer located in the caddy (Figure 5C). Release the
handle to lock the inserter to the spacer (Figure 5D). Trial
sizes and configurations are shown below (Table 2).

Figure 5C

Figure 5D

Trial Spacer Height (X)

71-TRL-S-(X)-F 5, 6 or 7mm

71-TRL-SD-(X)-F 5, 6 or 7mm

71-TRL-M-(X)-F 5, 6 or 7mm

71-TRL-MD-(X)-F 5, 6 or 7mm

Table 2 - Trial Spacer Sizing

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 SURGICAL TECHNIQUE

Assess trial spacers using lateral fluoroscopy to verify

appropriate height.

Gently tap trial spacer into the targeted disc space starting
with the smallest height first and increasing in size until the
spacer fits snugly in the disc space (Figure 5E). Oversizing COR Marker

the device will limit disc motion and may lead to instability.
INCORRECT

Using the indicator on the trial spacer, verify that the center
of rotation (COR) will be placed approximately at the
midline of the inferior vertebral body (Figure 5E). Perform
additional discectomy as necessary to achieve proper
position.

CORRECT HEIGHT
Once the trial spacer size and position have been
determined, leave the trial spacer attached to the inserter
Figure 5E
and prepare the site for implantation. Prior to drilling, verify
the trial spacer is parallel in a transverse plane to both
the superior and inferior endplates (Figure 5F) and that
distraction has been removed.

Figure 5F

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SURGICAL TECHNIQUE

6 ENDPLATE PREPARATION (DRILLING)

Three progressively-sized drills are provided. Each drill’s

shaft is etched with a band to indicate its shaft length
(one band indicates the shortest shaft and thus the first
drilling instrument).

With the trial inserter still connected to the trial spacer,

begin drilling with the shortest drill (identified by a single
etch mark and attached to the “quick-connect” driver) in
either superior hole of the trial spacer until the drill has
reached the safety shoulder of the drill guide and can no
Figure 6A
longer advance into the vertebral body (Figure 6A).

Proceed in sequential order, shortest drill to longest, until

all three holes are made (Figure 6B). Insert the third drill
into the bottom hole after removing the trial inserter but
leaving the spacer in place (Figure 6C).

Leave each drill in the trial spacer after use.

Note: The trial spacer is not secure until two drills are bored into
the vertebral body, therefore, it is important not to remove the trial
inserter until after the two superior drills have been bored into the
superior vertebral body.

Figure 6B

Figure 6C

10
 SURGICAL TECHNIQUE

After all three drills have been used, remove them by

rotating clockwise. Begin with the longest drill (three etch
marks), followed by the medium (two etch marks) and
finally, the shortest (one etch mark). Once the drills are
removed, re-insert the trial inserter into the trial spacer and
remove the trial spacer from the disc space (Figure 6D).

A nerve hook should be used to confirm adequate scoring

of the endplates as well as to remove any bone debris.
Drilling should be followed by copious irrigation.

Note: Drilled channels allow for minimal hammering and minimal

effort to insert the NuNec implant (Figure 6E). Figure 6D

IMPORTANT: Apply distraction to maintain disc height to that of

the selected implant height.

Surgical Tip: Keep the trial spacer in the affected disc space until
after the NuNec implant is selected and loaded onto the implant
inserter.

Figure 6E

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SURGICAL TECHNIQUE

Implant Foorprint (D x W) Implant Height (X)

7 IMPLANTATION
71-S-X or 73-S-X Small (12 x 14mm) 5, 6 or 7mm

Select the appropriate implant based on the footprint size 71-SD-X or 73-SD-X Small Deep (14.5 x 14mm) 5, 6 or 7mm
and disc height indicated by the trial spacer used in the 71-M-X or 73-M-X Medium (14.5 x 17mm) 5, 6 or 7mm
procedure. Select the cam whose color matches both the 71-MD-X or 73-MD-X Medium Deep (17 x 17mm) 5, 6 or 7mm
trial spacer and drills used in the prior step. Table 3 - Implant Sizing

Table 3 may be used as a guide to select the appropriate

implant.

With the locking arm up, align the posts of the implant
inserter with the bores in the implant and push the
leading edge of the implant inserter into the NuNec
implant (Figure 7A). Verify engagement (Figure 7B).
Once in position, flip the locking arm down to lock the Figure 7A

implant onto the implant inserter (Figure 7C).

Verify all four posts of the inserter are engaged with the
implant (Figure 7D).

Verify:

1) Alignment (Figures 7A and 7B)

2) Engagement (Figure 7C)

3) Attachment (Figure 7D) Figure 7B

Note: If implant has been removed from original packaging, see

Appendix A for alternative loading method.

Figure 7C

Figure 7D

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 SURGICAL TECHNIQUE

Align the cams of the NuNec implant (two superior, one

inferior) with the pre-drilled channels (Figure 7E) and
insert the implant into the vertebral body.

With the implant on the implant inserter, verify posterior

location via lateral fluoroscopy and midline position via
A/P fluoroscopy. Figure 7F is a visual representation of a
“73-” implant under fluoroscopy.

Note: “71-” implants do not have COR markers.

The posterior aspect of the NuNec implant should be

approximately 2mm from the posterior vertebral body on Figure 7E
lateral fluoroscopy.

Remove the distraction system (leaving pins in place).

COR
Markers
Release the implant from the implant inserter by flipping
the locking arm up (Figure 7G).

Adjustment tools are available if the implant needs to be

repositioned.

Surgical Tip: The NuNec implant may be gently tapped into

position under lateral fluoroscopy to verify proper positioning and
advancement of the device..
5mm Only 6 & 7mm

Note: If manual manipulation is insufficient, the provided mallet

Figure 7F
should be used.

Figure 7G

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SURGICAL TECHNIQUE

8 IMPLANTATION FIXATION

Use the implant spacer to position the NuNec implant

and correctly align the upper and lower components of
the implant to the superior and inferior endplates of the
vertebral body.

With the implant spacer in place, use the Implant driver to

affix (lock) the two superior cams into the vertebral body
by turning the driver 180 degrees.

Implant Spacer
Turn the superior cams from medial to lateral, i.e. turn
Figure 8A
the right cam clockwise (Figure 8A). Turn the left cam
counterclockwise (Figure 8B). Always turn the cams
slowly to ensure complete engagement into the vertebral
endplates and prevent over-rotation.

Note: Unlocked cams appear with the black portion of the cam
heads facing toward the implant. When locked, the black portion
of the cam heads should face outward (toward the vertebral
bodies) (Figure 8C). Use lateral fluoroscopy for final verification
of complete implant engagement.

Figure 8B

Figure 8C

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 SURGICAL TECHNIQUE

9 FINAL PLACEMENT & CLOSURE

Verify proper implant depth, height and cam orientation

via lateral and A/P fluoroscopy. Figures 9A & B are visual
representations of a “73-” implant under fluoroscopy.

Note: “71-” implants do not have COR markers.

Re-approximate the platysma and subcutaneous layer of

the skin with suture followed by skin closure. Patients can
be mobilized out of bed without bracing on the day of
surgery.
Figure 9A
Post-op Care Note: Patient may experience “squeaking” of the
implant during initial post-op care until the body naturally lubricates
the device.

Figure 9B

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 APPENDIX A:
LOADING ALTERNATIVE

If removed from the original packaging, the following method

may be used to attach the implant inserter to the implant.

The selected implant should be loaded into the appropriate slot

on the underside of the caddy. The appropriate implant slot
corresponds with the final trial spacer used during trialing.

Using the implant inserter with locking arm up, align the posts Figure A1
with the bores in the implant and push the leading edge of
the implant inserter into the NuNec implant (Figure A1). Verify
engagement (Figure A2). Once in position, flip the locking arm
down to lock the implant onto the implant inserter (Figure A3).
Verify all four posts of the implant inserter are engaged with the
implant (Figure A4).

Verify:

1) Alignment (Figure A1)

2) Engagement (Figure A2)

Figure A2

3) Attachment (Figure A3)

Figure A3

Figure A4

16
 INDICATIONS
& WARNINGS
INDICATIONS
The NuNec is indicated in skeletally mature patients with cervical
degenerative disc disease (DDD) for reconstruction of the disc
from C3-C7. DDD is defined as intractable radiculopathy and/
or myelopathy with at least one of the following conditions
confirmed via radiographic studies (e.g., CT, MRI, x-rays, etc.):
herniated nucleus pulposus, spondylosis (defined by the
presence of osteophytes), and/or the loss of disc height. Patients
should have failed six weeks of non-operative treatment prior to
receiving the NuNec Cervical Disc Replacement device. The
device is to be implanted via an open anterior approach.
CONTRAINDICATIONS
Do not apply in cases of:
• Active systemic infection or infection localized to the site of
implantation
• Osteoporosis defined as DEXA bone density measured T
score < -2.5
• Cervical instability on neutral resting flexion/extension or
lateral radiographs (indicated by translation > 3mm, and/or >
11° of rotational difference to either adjacent level)
• Allergy or sensitivity to PEEK, Titanium or Tantalum
• Severe spondylolisthesis characterized by bridging
osteophytes or a loss of disc height > 50%
• Conditions which may lead to bone formation (e.g.,
heterotopic ossification, fusion)
• Clinically compromised vertebral bodies at the affected
level due to current or past trauma (e.g., by radiographic
appearance of fracture callus, malunion, or nonunion)
PRECAUTION
The safety and effectiveness of this device has not been
established in patients with the following conditions:
• Skeletally immature patients
• Clinically significant cervical instability
• Prior fusion at adjacent cervical level
• Severe facet joint pathology of involved vertebral bodies
• Prior surgery at affected level
• Osteopenia, osteomalacia, Paget’s disease or other
metabolic bone disease (verified via DEXA T-score)
• Neck or arm pain of unknown etiology
• Spinal metastases
• Chronic or acute renal failure or history of renal disease
• Taking medications known to potentially interfere with bone/
soft tissue healing (e.g. steroids)
• Severe diabetes mellitus requiring daily insulin treatment
• Systemic disease including AIDS, HIV, and Hepatitis
• Active malignancy
18
Use care when handling the NuNec device to ensure that it does
not come in contact with objects that may damage the implant.
Use aseptic technique when removing the NuNec Cervical Disc
implant components from the innermost packaging.
Surgical implants must never be re-used or re-implanted. Even
though the device appears undamaged, it may have small defects
and internal stress patterns that may lead to early breakage.
Patients should be instructed in postoperative care procedures
and should be advised of the importance of adhering to these
procedures for successful treatment with the NuNec Cervical
Disc Replacement. This includes but is not limited to avoidance
of heavy lifting, repetitive bending, and high-impact exercise or
athletic activity for 60 days postoperative.
The NuNec Cervical Disc implant should not be used with
components or instruments of spinal systems from other
manufacturers. See surgical technique manual for step-by-step
instructions.
WARNING
The surgeon must read the physician’s surgical technique prior
to implanting the NuNec. A lack of adequate training may lead
to a higher incidence of adverse events, including neurological
complications. Correct placement of the NuNec implant is
essential to optimal performance.
Due to the proximity of vascular and neurological structures
to the implantation site, there are risks of serious or fatal
hemorrhage and risks of neurological damage with the use of
this device. Serious or fatal hemorrhage may also occur if the
great vessels are eroded or punctured during implantation
and are subsequently damaged due to breakage of implants,
migration of implants, or if pulsatile erosion of the vessels occur
because of close apposition of the implants.
This system has not been evaluated for safety and compatibility
in the MR environment. This system has not been tested for
heating or migration in the MR environment.
See insert for complete labeling limitations related
to this device.
Manufactured by Pioneer Surgical Technology, Inc.
DBA RTI Surgical.
19
 Pioneer Surgical Technology BV
Voorveste 7, 3992 DC Houten
The Netherlands
t: 31 30 693 47 20
f: 31 30 693 47 21
www.rtisurgical.com
info-houten@rtix.com

CoC Utrecht 30214021

Manufactured by:
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©2016 RTI Surgical, Inc. All rights reserved. 9485 R0 08/2016