VENUS
ANTERIOR CERVICAL PLATE
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Amendia
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VENUS
ANTERIOR CERVICAL PLATE
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SURGICAL TECHNIQUE GUIDE
Features and Benefits
Implant and Instrument Guide
Surgical Technique Guide
Indications/Contraindications/Warnings
Disclaimer:
2-6
7-13
14
The surgical technique shown is for illustrative purposes only. The technique(s) actually employed
in each case will always depend upon the medical judgment of the surgeon before and during
surgery as to the best mode of treatment for each patient. Please reference the 510K or
package insert for additional information and a complete list of intended indications, warnings,
precautions, and other medical information.
Features & Benefits
• Constructed of implant grade Titanium Alloy
(Ti 6Al-4V ELI)
• Plate thickness: 2.25 mm
• Maximum plate width: 18 mm
• Plate lengths: 22 mm - 92 mm
(measured from center of distal screw holes)
• Single level up to four level plates
• Unique integrated self-locking “S-clip” system
• ø4.0 mm and ø4.4 mm blunt, sharp, and extra sharp screws
• Fixed and variable screws for rigid, dynamic or
hybrid stabilization
• Offered in self-tapping
• Variable screws allow for 20° of freedom (+/- 10°)
• Color-coded screws based on diameter of
screws and fixed/variable head identification
• Pre-lordosed with medial/lateral curve
• Large window allows for graft visualization
• Strategically designed instrument set to minimize
operating time
MM-014, Rev. 4
Amendia
Vs
VENUS
1
ANTERIOR CERVICAL PLATE
Implants - Plates
1-Level
VCP122
VENUS Cervical Plate, 1 level, 22mm L
VCP124
VENUS Cervical Plate, 1 level, 24mm L
VCP126
VENUS Cervical Plate, 1 level, 26mm L
VCP128
VENUS Cervical Plate, 1 level, 28mm L
VCP130
VENUS Cervical Plate, 1 level, 30mm L
VCP132
VENUS Cervical Plate, 1 level, 32mm L
VCP134
VENUS Cervical Plate, 1 level, 34mm L
One Level Plate
2-Level
VCP236
VENUS Cervical Plate, 2 level, 36mm L
VCP239
VENUS Cervical Plate, 2 level, 39mm L
VCP242
VENUS Cervical Plate, 2 level, 42mm L
VCP245
VENUS Cervical Plate, 2 level, 45mm L
VCP248
VENUS Cervical Plate, 2 level, 48mm L
VCP251
VENUS Cervical Plate, 2 level, 51mm L
VCP254
VENUS Cervical Plate, 2 level, 54mm L
Two Level Plate
Three Level Plate
3-Level
VCP353
VENUS Cervical Plate, 3 level, 53mm L
VCP356
VENUS Cervical Plate, 3 level, 56mm L
VCP359
VENUS Cervical Plate, 3 level, 59mm L
VCP362
VENUS Cervical Plate, 3 level, 62mm L
VCP365
VENUS Cervical Plate, 3 level, 65mm L
VCP368
VENUS Cervical Plate, 3 level, 68mm L
VCP371
VENUS Cervical Plate, 3 level, 71mm L
VCP374
VENUS Cervical Plate, 3 level, 74mm L
VCP377
VENUS Cervical Plate, 3 level, 77mm L
Four Level Plate
4-Level
VCP468
VENUS Cervical Plate, 4 level, 68mm L
VCP472
VENUS Cervical Plate, 4 level, 72mm L
VCP476
VENUS Cervical Plate, 4 level, 76mm L
VCP480
VENUS Cervical Plate, 4 level, 80mm L
VCP484
VENUS Cervical Plate, 4 level, 84mm L
VCP488
VENUS Cervical Plate, 4 level, 88mm L
VCP492
VENUS Cervical Plate, 4 level, 92mm L
Implant and Instrument Guide
2
Implants - Screws
Ø4.0 Fixed - Sharp*
Ø4.0 Variable - Sharp*
VSF4012
Cervical Screw, Fixed, Ø4.0 x 12mm L
VSV4012
Cervical Screw, Variable, Ø4.0 x 12mm L
VSF4014
Cervical Screw, Fixed, Ø4.0 x 14mm L
VSV4014
Cervical Screw, Variable, Ø4.0 x 14mm L
VSF4016
Cervical Screw, Fixed, Ø4.0 x 16mm L
VSV4016
Cervical Screw, Variable, Ø4.0 x 16mm L
VSF4018
Cervical Screw, Fixed, Ø4.0 x 18mm L
VSV4018
Cervical Screw, Variable, Ø4.0 x 18mm L
VSF4020
Cervical Screw, Fixed, Ø4.0 x 20mm L
VSV4020
Cervical Screw, Variable, Ø4.0 x 20mm L
Ø4.4 Fixed - Sharp*
Ø4.4 Variable - Sharp*
VSF4412
Cervical Screw, Fixed, Ø4.4 x 12mm L
VSV4412
Cervical Screw, Variable, Ø4.4 x 12mm L
VSF4414
Cervical Screw, Fixed, Ø4.4 x 14mm L
VSV4414
Cervical Screw, Variable, Ø4.4 x 14mm L
VSF4416
Cervical Screw, Fixed, Ø4.4 x 16mm L
VSV4416
Cervical Screw, Variable, Ø4.4 x 16mm L
VSF4418
Cervical Screw, Fixed, Ø4.4 x 18mm L
VSV4418
Cervical Screw, Variable, Ø4.4 x 18mm L
VSF4420
Cervical Screw, Fixed, Ø4.4 x 20mm L
VSV4420
Cervical Screw, Variable, Ø4.4 x 20mm L
Ø4.0 Fixed - Blunt*
Ø4.0 Variable - Blunt*
VCF4012
Cervical Screw, Fixed, Ø4.0 x 12mm L, Blunt
VCV4012
Cervical Screw, Variable, Ø4.0 x 12mm L, Blunt
VCF4014
Cervical Screw, Fixed, Ø4.0 x 14mm L, Blunt
VCV4014
Cervical Screw, Variable, Ø4.0 x 14mm L, Blunt
VCF4016
Cervical Screw, Fixed, Ø4.0 x 16mm L, Blunt
VCV4016
Cervical Screw, Variable, Ø4.0 x 16mm L, Blunt
VCF4018
Cervical Screw, Fixed, Ø4.0 x 18mm L, Blunt
VCV4018
Cervical Screw, Variable, Ø4.0 x 18mm L, Blunt
VCF4020
Cervical Screw, Fixed, Ø4.0 x 20mm L, Blunt
VCV4020
Cervical Screw, Variable, Ø4.0 x 20mm L, Blunt
Ø4.4 Fixed - Blunt*
Ø4.4 Variable - Blunt*
VCF4412
Cervical Screw, Fixed, Ø4.4 x 12mm L, Blunt
VCV4412 Cervical Screw, Variable, Ø4.4 x 12mm L, Blunt
VCF4414
Cervical Screw, Fixed, Ø4.4 x 14mm L, Blunt
VCV4414 Cervical Screw, Variable, Ø4.4 x 14mm L, Blunt
VCF4416
Cervical Screw, Fixed, Ø4.4 x 16mm L, Blunt
VCV4416 Cervical Screw, Variable, Ø4.4 x 16mm L, Blunt
VCF4418
Cervical Screw, Fixed, Ø4.4 x 18mm L, Blunt
VCV4418
Cervical Screw, Variable, Ø4.4 x 18mm L, Blunt
VCF4420
Cervical Screw, Fixed, Ø4.4 x 20mm L, Blunt
VCV4420
Cervical Screw, Variable, Ø4.4 x 20mm L, Blunt
*The VENUS® sharp screws and blunt screws are optional
Implant and Instrument Guide
3
Implants - Screws
Ø4.0 Fixed - Xtra Sharp**
Ø4.0 Variable - Xtra Sharp**
VXSF4012
Cervical Screw, Fixed, Ø4.0 x 12mm L, Xtra Sharp
VXSV4012
Cervical Screw, Variable, Ø4.0 x 12mm L, Xtra Sharp
VXSF4014
Cervical Screw, Fixed, Ø4.0 x 14mm L, Xtra Sharp
VXSV4014
Cervical Screw, Variable, Ø4.0 x 14mm L, Xtra Sharp
VXSF4016
Cervical Screw, Fixed, Ø4.0 x 16mm L, Xtra Sharp
VXSV4016
Cervical Screw, Variable, Ø4.0 x 16mm L, Xtra Sharp
VXSF4018
Cervical Screw, Fixed, Ø4.0 x 18mm L, Xtra Sharp
VXSV4018
Cervical Screw, Variable, Ø4.0 x 18mm L, Xtra Sharp
VXSF4020
Cervical Screw, Fixed, Ø4.0 x 20mm L, Xtra Sharp
VXSV4020
Cervical Screw, Variable, Ø4.0 x 20mm L, Xtra Sharp
Ø4.4 Fixed - Xtra Sharp**
Ø4.4 Variable - Xtra Sharp**
VXSF4412
Cervical Screw, Fixed, Ø4.4 x 12mm L, Xtra Sharp
VXSV4412
Cervical Screw, Variable, Ø4.4 x 12mm L, Xtra Sharp
VXSF4414
Cervical Screw, Fixed, Ø4.4 x 14mm L, Xtra Sharp
VXSV4414
Cervical Screw, Variable, Ø4.4 x 14mm L, Xtra Sharp
VXSF4416
Cervical Screw, Fixed, Ø4.4 x 16mm L, Xtra Sharp
VXSV4416
Cervical Screw, Variable, Ø4.4 x 16mm L, Xtra Sharp
VXSF4418
Cervical Screw, Fixed, Ø4.4 x 18mm L, Xtra Sharp
VXSV4018
Cervical Screw, Variable, Ø4.4 x 18mm L, Xtra Sharp
VXSF4420
Cervical Screw, Fixed, Ø4.4 x 20mm L, Xtra Sharp
VXSV4020
Cervical Screw, Variable, Ø4.4 x 20mm L, Xtra Sharp
**The VENUS® extra sharp screws are included
Instruments
VCT4016
Bone Tap, Ø 4.0
VCFG001
Fixed Angle Screw/Drill Guide
VCT4416
Bone Tap, Ø 4.4
VCCA001
VCB2412
Conical Awl
Drill Bit, Ø2.4 x 12mm long
VCCH001
VCNC002***
Mini AO Chuck Handle
Neuro Caliper, 45° Angle, Ratcheting
VCB2414
VCB2416
Drill Bit, Ø2.4 x 14mm long
Drill Bit, Ø2.4 x 16mm long
VCPB001
VCPH001
Plate Bender
Plate Holder
VCSD001
Screw Driver
VCB2414X
VCBG001
Drill Bit, Ø2.4 x 14mm long, X-Long
Drill Bit Guide
VCSR002
VCFP001
Screw Removal Tool (Clip Pusher)
Temporary Fixation Pin
VCDG001
VCFH001
Dual-Barrel Screw/Drill Guide
Fixation Pin Holder
VCVG001
VCCS01
Variable Angle Screw/Drill Guide
VENUS Transportation Case
***VCNC001, Straight, Non-Ratcheting versions available upon request.
Amendia
Vs
Implant and Instrument Guide
VENUS
4
ANTERIOR CERVICAL PLATE
Instruments
VCT4016 Bone Tap, Ø 4.0
VCT4416 Bone Tap, Ø 4.4
VCCA001 Conical Awl
VCB2412
Drill Bit, Ø2.4 x 12mm long
VCB2414
VCB2416
VCB2414X
Drill Bit, Ø2.4 x 14mm long
Drill Bit, Ø2.4 x 16mm long
Drill Bit, Ø2.4 x 14mm long, X-Long
VCBG001
Drill Bit Guide
VCFH001
VCFP001
Fixation Pin Holder
Temporary Fixation Pin
VCDG001
Dual-Barrel Screw/Drill Guide
Implant and Instrument Guide
5
VCFG001
Fixed Angle Screw/Drill Guide
Instruments
VCNC002 Neuro Caliper, 45° Angle, Ratcheting
VCVG001 Variable Angle Screw/Drill Guide
VCPH001 Plate Holder
VCSD001 Screw Driver
VCSR002 Screw Removal Tool (S-Clip Pusher)
VCPB001 Plate Bender
VCCH001 Mini AO Chuck Handle
Implant and Instrument Guide
6
Step 1: Surgical Approach and Preparation
The patient is placed in position supine and a classic anterior approach is made from the left or
right allowing access to the anterior surface of the lower cervical vertebral column. The ventral
cortical surface must be free of osteophytes and smooth in profile prior to placement of the
VENUS® Plate.
Step 2: Plate Sizing
The Plate Caliper has a 7° lordotic footprint. Place the footprints of the Caliper to span the exact
length of the proposed level to be fused. The footprint measures from end to end-plate length.
Length is read off the window on the side of the Caliper arm.
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Surgical Technique Guide
Step 3: Plate Bending
The VENUS® Anterior Cervical Plate is contoured for lordosis and vertebral body diameter. In most
the Plate Bender. To modify the lordotic curve, carefully attach the VENUS® Cervical Plate inside
the Plate Bender within the “bending zones”.
Note: “Bending zone” is the area between the screw hole pairs.
STEP 4: Plate Positioning
Grasp the VENUS® Plate with the Plate Holder by opening the scissor-style locked instrument and
its desired position. Make sure the plate is not compromising the adjacent disc space.
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Surgical Technique Guide
STEP 5: Temporary Fixation Pins
VENUS®
position. To load the pin into the Pin Holder, slide the Holder Tube backward and insert the pin.
Push the tube forward to engage the pin. Pin is placed into screw hole and tapped into position.
To release the pin, slide holder tube sleeve backward to disengage the pin. Pins should be
placed diagonally for maximum fixation.
to screw placement and closure of incision.
STEP 6: (Option A.1) Drilling Screw Holes - Dual Guide
The VENUS® Fixed Angle Dual Screw/Drill Guide permits pre-drilling and screw placement all in
one step without removing the Drill Guide. The distal end of the VENUS® Fixed Angle Dual Guide
fits into the two holes of the VENUS® Plate. Place the assembled manual Drill Bit with safety stop
into the Drill Sleeve and advance to predetermined measured depth. Drill will stop at desired
depth. May advance Drill short of safety stop to minimize risk of screw stripping. To remove, gently
back out Drill from Drill Sleeve.
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Surgical Technique Guide
STEP 6: (Option A.2) Screw Placement - Dual Guide
Select a screw which corresponds to the appropriate drill depth. Place screw onto the VENUS®
Screwdriver inserting the screw into the Drill Guide Sleeve. Advance and tighten the screw until the
screw clears the Drill Sleeve. The Drill Guide will disengage from screw. Repeat the same steps on the
STEP 6: (Option B.1) Drilling Screw Holes - Variable Guide
VENUS®
the variable angle can be adjusted not to exceed 10º. Place the assembled manual drill into
the Drill Sleeve and advance the predetermined measured depth. May advance Drill Bit short of
safety stop to minimize screw stripping. To remove, gently back out drill from Drill Sleeve.
Note: Excessive angulation force on any Drill Guide should be avoided. Over angulation of the
drill hole beyond 10º may result in failure of the screw to engage the VENUS® Plate and/or locking
mechanism.
10
Surgical Technique Guide
STEP 6: (Option B.2) Screw Placement - Variable Guide
Select a screw which corresponds to the appropriate predetermined drill depth. Place the screw
onto the VENUS® Screwdriver, inserting the screw into the Drill Guide Sleeve. Advance and tighten
the screw until the screw clears the Drill Sleeve. The Drill Guide will disengage from the screw.
Complete final tightening.
STEP 6: (Option C.1) Screw Placement Free Hand Using Fixed Angle Drill Guide
Assemble/attach restricted Fixed Angle Screw/Drill Guide to manual assembly. The distal end of
the extended length free hand Drill Guide fits into the VENUS® Plate. Place the manual drill with
the safety stop into the Drill Sleeve and advance to the determined depth. Drill should stop at
predetermined measured depth. To remove, gently back out drill from Drill Sleeve.
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Surgical Technique Guide
STEP 6: (Option C.2) Screw Placement - Free Hand
Remove the Drill Guide from the VENUS® Plate. Select a screw which corresponds to the
appropriate drill depth. Place the screw onto the VENUS® Screwdriver. Adjust the screw to the
desired trajectory, not to exceed 10° in Cephalad and Caudal Screws and 0° in the intermediate
screw hole locations. Advance the screws with the plate. Complete the final tightening.
STEP 6: (Option D.1) Screw Preparation/Cortical Punch AWL Option
The distal end of the Cortical Punch AWL (8mm tip length) fits directly into the screw holes of the
VENUS® Plate. Determine the desired angle for the Punch AWL, not to exceed 10° in the
Cephalad and Caudal screw holes, and 0° in the intermediate holes. Apply gentle downward
pressure to the AWL to penetrate the anterior cortical wall of the vertebral body. The olive tip
seats in the plate hole with maximum depth at 8mm.
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Surgical Technique Guide
STEP 6: (Option D.2) Screw Placement - Free Hand
Select a screw which corresponds to the appropriate drill depth. Adjust the screw to the desired
trajectory not to exceed 10º in the Cephalad and Caudal Screws, and 0º in the intermediate
STEP 7: Screw Removal Option
The VENUS® Plate has an S-Clip which retracts with lateral pressure. If removal of a screw is
required, place the sleeve of the Screw Removal Instrument onto the Screw Driver. Insert Screw
Driver tip over bone screw to be removed. Slide distal end of Screw Removal Tool with the distal
window straddling the S-Clip. Turn the instrument one-quarter turn to retract the Clip. Place the
Screwdriver into the sleeve of the instrument, and turn the screw counter-clockwise to remove
the Screw. This can be repeated for removal of all screws. Once all screws have been removed,
the Plate can be removed using forceps.
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Surgical Technique Guide
Indications/ Contraindications/Warnings
Indications for Use:
The Venus Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an
adjunct to fusion of the cervical spine (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the
development of cervical spinal fusion in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration
of the disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (i.e. fractures or dislocations); tumors; deformity (defined
as kyphosis, lordosis, or scoliosis); pseudarthrosis; failed previous fusion; spinal stenosis.
WARNING:
This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Contraindications include, but are not limited to:
• Overt infection or distant foci of infections
• Local inflammation, with or without fever or leukocytosis
• Pregnancy
• Diseases or conditions other than those specifically described in the Indications section
• Use in the posterior elements (pedicles) of the cervical, thoracic, or lumbar vertebrae, where attempted correction exceeds the limits of
physiological conditions
• Uncooperative patient or patient with neurologic disorders rendering the patient incapable of following instructions
• Metabolic disorders that may impair bone formation
• Inadequate bone stock to support the device
• Inability to restrict high activity level
• Obesity, poor prognosis for good wound healing (e.g. decubitus ulcer, end-stage diabetes, severe protein deficiency and/or
malnutrition)
• Failure to explant the device after bony fusion
WARNINGS:
The following are specific warnings, precautions and adverse effects that should be understood by the surgeon and explained to the patient. These
warnings do not include all adverse effects that can occur with surgery in general, but are important considerations particular to metallic internal
fixation devices. General surgical risks should be explained to the patient before surgery.
Potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of
fixation, nonunion, fracture of the vertebra, neurological injury, and vascular or visceral injury.
1. CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. The potential for satisfactory fixation is increased by the selection of the
proper size, shape, and design of the implant.
2. IMPLANTS CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNION OR NONUNION. Internal fixation
appliances are load-sharing devices that are used to obtain alignment until normal healing occurs.
3. MIXING METALS CAN CAUSE CORROSION. There are many forms of corrosion damage and several of these occur on metals surgically
implanted in humans.
4. PATIENT SELECTION. In selecting patients for internal fixation devices, the following factors can be extremely important to the eventual
success of the procedure:
A. The patient’s occupation or activity. If the patient is involved in an occupation or activity that includes heavy lifting, muscle strain,
twisting, repetitive bending, stooping, running, substantial walking, or manual labor, he/she should not return to these activities until
the bone is fully healed.
B. A condition of senility, mental illness, alcoholism, or drug abuse. These conditions, among others, may cause the patient to ignore
certain necessary limitations and precautions in the use of the appliance, leading to implant failure or other complications.
C. Certain degenerative diseases. In some cases, the progression of degenerative disease may be so advanced at the time of
implantation that it may substantially decrease the expected useful life of the appliance.
D. Foreign body sensitivity. The surgeon is advised that no pre-operative test can completely exclude the possibility of sensitivity or
allergic reaction.
E. Smoking. Patients who smoke have been observed to experience higher rates of pseudarthrosis following surgical procedures where
bone graft is used.
5. The Venus™ Cervical Plate has not been evaluated for safety and compatibility in the MR environment. The Venus™ Cervical Plate has
not been tested for heating or migration in the MR environment.
6. This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar
spine.
7. Implants that contain nitinol should not be used in patients with nickel sensitivities or allergies.
8. Mixing titanium, titanium alloy, or cobalt-chromium-molybdenum alloy with stainless steel implant components is not recommended, for
metallurgical, mechanical and functional reasons.
Indications/ Contraindications/Warnings
14
1755 West Oak Parkway
Marietta, GA 30062
Phone: 877-755-3329
Fax: 877-420-1213
www.Amendia.com
info@amendia.com
MM-014, Rev. 4