718-05-30_RevA_Equinoxe_FxPlate_OpTech

8/4/2019 718-05-30_RevA_Equinoxe_FxPlate_OpTech

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ANATOMICAL.

REDEFINED.

Operative Technique

Fx PLATE


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Table o ConTenTs

INTRODUCTION.....................................................................................1

OVERVIEW TECHNIQUE ........................................................................2DETAILED OPERATIVE TECHNIQUE .....................................................4

INDICATIONS ..................................................................................4

PRE-OPERATIVE PLANNING ..........................................................4

PATIENT POSITIONING ..................................................................4

SURGICAL APPROACH ...................................................................4

Deltopectoral Approach ..........................................................4

Superolateral Approach .........................................................4

FRACTURE REDUCTION ................................................................5

INITIAL PLACEMENT OF Fx PLATE ...............................................6

SETTING F PLATE HEIGHT ..........................................................7

SCREW AND BLADE PLACEMENT ................................................7

PREPARING FOR CANCELLOUS LOCKING SCREWS ..................8

IMPLANTING LOCKING BLADE .....................................................9

PLACING DISTAL CORTICAL LOCKING SCREWS ......................10

APPLYING SUTURES TO F PLATE.............................................. 11

WOUND CLOSURE ....................................................................... 11

POST-OPERATIVE REHABILITATION ........................................... 11

IMPLANT REMOVAL ..................................................................... 11

sysTEm sPECIfICATIONs ..................................................................12

EQUINOXE ImPLANT sCOPE .............................................................13

EQUINOXE fx PLATE INsTRUmENT LIsTING...................................15

EQUINOXE INsTRUmENT LIsTING ...................................................16


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1

The Equinoe Shoulder System redenesanatomical.The primary stem allows

independent adjustability o all ouranatomic parameters in situ. The reverse

shoulder is an optimized design that

minimizes both scapular notching andtorque on the glenoid while seamlessly

integrating with the primary stem. Theplatorm racture stems oset anterior-

lateral n and asymmetric tuberosity

beds dene the net generation incomple racture reconstruction. The F

Plate provides multiple congurations oblades and screws to address a myriad

o classications o proimal humerus

ractures.

Throughout the development process, our

team has collaborated on every acet o the

Equinoe Shoulder System including thisoperative technique. We began the product

development process by identiyingconcerns our team had with the treatment

options or comple ractures o the

proimal humerus as well as the specialsurgical challenges that nonunions provide.

Our goal was to develop solutions to thoseconcerns, and we believe the Equinoe F

Plate helps address the challenges you acein the O.R. every day. In general, we sought

the ollowing improvements:

anaToMIC. ReDeIneD.

The contoured plate is asymmetricproimally to align with the bicipital groove

and greater tuberosity, and to respect thedeltoid insertion. The suture holes are

anatomically oriented allowing surgeons

to more easily pass the suture ater theplate is secured to the bone.

MInIMIZe HUMeRal HeaD CollaPseUnique modular blades can be inserted

to urther buttress the reconstructionwhile locking screws diverge to support

the humeral head. The large central hole

allows or either a 6.5mm locking screw

or deployment o bone-void ller ater theplate is secured.

leXIbIlITYMultiple screw/blade congurations enablea surgeon to treat a spectrum o proimal

humeral ractures. Robust instrumentation

options are included to address a widearray o surgical technique preerences.

Thank you or considering the Equinoe F

Plate. We hope you come to agree, basedon your eperiences with the Equinoe in

the O.R., that we have accomplished ourgoals.

Respectully,

Kenneth A. Egol, mD

Pierre-Henri flurin, mD

Gregor Gilot, mD

Howard D. Routan, DO

Thoa W. Wright, mD

Joeph D. Zuckeran, mD

InTRoDUCTIon


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2

oVeRVIeW TeCHnIQUe

Pcmt x Pt

A

Prprig/Pcig Cmpri scrw

B

Prprig r Ccu lckig scrw

E

scrw Dpth Vrifcti

F

Pcig Ccu lckig scrw

G

sttig Pt Hight

C

scrw/bd opti

D


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3

Prprig Crtic lckig scrw

M

Pcig Crtic lckig scrw

N

Pcig sutur

O

Prprig Ctr H r lckig scrw

H

Prprig r lckig bd

I

Pcig lckig bd

J

Pcig bd lckig scrw

K

iig Vid with Grt (pti)

L


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4

DeTaIleD oPeRaTIVe TeCHnIQUe

InDICaTIonsThe Equinoe Proimal Humerus Fracture Plate

System is indicated or Open Reduction InternalFiation (ORIF) procedures o the proimal

humerus. The decision to proceed with ORIFshould refect careul consideration o both injury

and patient actors. Clinical indications include

ractures, racture dislocations, osteotomies andnon-unions o the proimal humerus.

PRe-oPeRaTIVe PlannInGAter a careul history and physical eamination,

including identication o the dominant hand and anassessment o activities o daily living, radiographs

should be obtained. A standard shoulder trauma

series should be obtained, including an AP view,scapular lateral view and an aillary view. A CT

scan may provide additional inormation aboutinvolvement o the humeral head and tuberosity

displacement. Although not routinely required,

reormatted reconstruction views can be obtained

to provide additional inormation about ractureanatomy.

Other things to consider during the eaminationare the length o time since the injury occurred,

conditions predisposing the patient to seizure andneurologic and vascular actors.

PaTIenT PosITIonInGIt is recommended that the patient be placed on anoperating table in a supine position. The head o the

operating table should be elevated approimately30 to 60 degrees in a modied beach chair position.

It is recommended that the image intensier is

placed above the patients head to acilitate biplanefuoroscopy. It is critical to ensure that positioning

will allow live AP and aillary view images priorto draping. A small bolster should be placed

laterally behind the involved shoulder. The patientshould be moved to the side o the table so that

the upper etremity can be placed in maimum

etension without obstruction by the operatingtable. Alternatively, a Captains chair or similar

positioning device can be used or proper patientpositioning. The patient should be secured to the

operating table to minimize any changes in position

intra-operatively. The entire upper etremity shouldbe prepped and draped to allow complete access

to the operative area and ull mobility during theprocedure. Either a deltopectoral or a superolateral

approach may be used depending on the surgeons

preerence and clinical parameters.

sURGICal aPPRoaCHDeltopectoral Approach

A straight deltopectoral incision is made beginning

just lateral to the tip o the coracoid process andetending distally and laterally to the insertion o

the deltoid. The subcutaneous tissues are dividedand medial and lateral faps are elevated to epose

the deeper muscular layers.

The deltopectoral interval is identied bylocalization o the cephalic vein. The cephalic vein is

usually retracted laterally with the deltoid muscle.

In some instances the cephalic vein is more easilyretracted medially with the pectoralis major. In

either case, care should be taken to preserve thecephalic vein throughout the procedure.

The subdeltoid space is mobilized, as is the pectoralis

major. The conjoined tendon muscles are identiedand the clavipectoral ascia is divided at the medial

edge o the conjoined tendon muscles. The racture

hematoma is usually evident ater dividing theclavipectoral ascia. The conjoined tendon muscles

and the pectoralis major are retracted medially andthe deltoid is retracted laterally. This can be most

easily accomplished with the use o a sel-retaining

type o retractor. Depending on plate length, aportion o the deltoid insertion should be released.

Ater the racture hematoma has been evacuated,the deeper structures can be visualized. The biceps

tendon should be identied as it provides an

orientation to the greater and lesser tuberosities.The humeral shat may be internally or eternally

rotated to provide access to the greater or lessertuberosities.

superolateral Approach

A deltoid splitting approach to the lateral aspect othe proimal humerus can also be used. The skin

incision can be either a vertical incision starting at

the lateral aspect o the acromion or an ellipticalincision that faps down to epose the deltoid.

In either case, the muscle is split longitudinallybeginning at the lateral aspect o the acromion.

The aillary nerve must be identied and protectedas it passes across the split. The nerve creates two

sot-tissue windows, one above and one below

the nerve, which provide access to the displacedtuberosities and head segments (above) and

the humeral shat (below). The advantage othis approach is improved access to posteriorly

displaced greater tuberosity ragments. Thedisadvantage is potential damage to the aillarynerve and higher risk o heterotopic ossication.


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RaCTURe ReDUCTIonOnce the racture ragments have been identied

several braided, non-absorbable sutures arepassed through the tuberosity-rotator cu tendon

interace and mobilized. Under fuoroscopy, the

humeral head segment is elevated and the racturemay be reduced using a broad osteotome. Care

is taken to avoid disrupting the medial sot-tissuehinge.

During the racture reduction, sutures and K-wires

can be used to provide provisional stabilization bothbeore applying the plate and during implantation

Care should be taken with placement o K-wires

so they will not interere with the placement othe racture plate. There are three locations on the

plate that will allow a K-wire (0.062 inches) to passthrough or provisional ation.

Depending on the racture pattern, there are

two strategies to consider while implanting theProimal Humerus F Plate: provisionally reducing

the racture with sutures and/or K-wires beore

applying the F Plate or applying the F Plate andreducing the racture to it. Please consider the

ollowing pearls:

Assoonasthehumerusisexposed,immediately

tag the tendon-bone junction o the anterior,

superior and posterior cu with sutures toestablish control. Manipulating these sutures

can be helpul to reduce the racture.

Placesuturesbetweenthefragmentsandreduce

them around the humeral head to hold it in place

Whenapplyingtheplate,theCopreion screw

is usually inserted rst, ollowed by Cancellou

Locking screw, Hueral Blade/Blade Locking

screw and Cortical Locking screw.

Oncetheplateisnearlysnugtothebone,recheckthe plate height and adjust the plate by sliding it

along the Compression Screw in the shat slotWhen the proper height is determined, tighten

the Compression Screw.

Ifapplyingtheplatepriorto fracturereduction

the height does not need to be perect since the

Compression Screw slot on the shat allows or

adjustment (4.8mm).

While positioning the plate, check the plate

height using the Targeting Jig and identiy thetrajectory o the lowest screws or blade into the

humeral head using the Blade K-Wire Guide, as

this is a critical component o the stability o theracture construct.

While r edu ci ng t he fr ac ture , che ck th e

relationships between the humeral head,tuberosities and humeral shat.


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figure 1

Placement o Fx Plate

12 mm

figure 2

Placing Compression Screw

InITIal PlaCeMenT o X PlaTeA racture plate o appropriate length is selected

and the Targeting Jig (let or right) is screwed intoplace on the F Plate. The Targeting Jig Handle may

be used or placing the plate onto the humerus. The

plate is applied to the lateral aspect o the humerusand shat along the bicipital groove. The superior

tip o the plate is positioned approimately 12mmdistal to the superior greater tuberosity (Figure 1).

Note:Plate lengths o 80, 115, 150mm are oered.

A non-locking, bi-cortical Compression Screw

placed through the slotted hole o the plate shouldbe used to bring the humeral shat to the plate

(Table 1).This will also allow the plate to be adjusted

either proimally or distally along the humeralshat. First the hole is drilled using the 3.3 DrillBit. Once the depth is determined using a Depth

Gauge, the appropriately sized Compression Screw

is then inserted (Figure 2).

TABLE 1 Crtic Cmpri d lckig scrw

Dimtr (mm) lgth (mm) Cr-cd

3.8

20 Black23

26 Orange

29

32 Blue


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seTTInG x PlaTe HeIGHTThere are three options available to set the height

o the racture plate along the humerus.

1) Using fuoroscopy, the plate height can bedetermined using the central hole o the plate

A 0.062 inch K-wire is placed through this holeand should bisect the diameter o the articular

surace (Figure 3).

2) The plate height can be determined o the

greater tuberosity using a 0.062 inch K-wirethrough the superior hole o the Targeting Jig

(Figure 4).

3) Using theinerior blade location and the BladeK-wire Guide, a 0.062 inch K-wire could be

placed along the inerior aspect o the headneck junction to assess the plate height under

fuoroscopy (Figure 5).

sCReW anD blaDe PlaCeMenTOnce the F Plate height has been determined,

the surgeon may then prepare the humerus orthe placement oCancellous Locking Screws and

Blades.The F Plate provides multiple options oroptimal Screw and Blade ation (Figure 6). The

order o placement o these devices is determined

intra-operatively.

1) Using only Cancellous Locking Screws, thereare si 3.8mm ed-angle screw holes and one

6.5mm screw hole available.

2) Using the blade option, the two locationsshown can also be used or implanting a

Locking Blade with two Blade Locking Screws(Figure 6a).

Note: A Blade in the superior slot would be useul

in a valgus impacted racture while a Blade in theinerior slot would be useul to keep the humera

head rom collapsing into varus.

figure 3Setting Plate Height Using

Central Hole

figure 4

Setting Height o Greater

Tuberosity

figure 5Setting Height with

Inerior Blade

figure 6Screw/Blade Option

Note: Place either two Screws or a Blade with two Blade Locking Screws

figure 6aLocking Blade Insertion Points


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PRePaRInG oR CanCelloUs loCKInG sCReWsSurgeons can choose to prepare or the 3.8mm

screws with either 2.8mm or 3.3mm instrumentation(i.e. drills and drill guides) based on surgeon

preerence, bone quality and other relevant

actors. With the Targeting Jig attached to the FPlate, the Tapered Drill Guide Tube is connected

into position. I preerred, a Threaded Drill Guidecan be alternately threaded into the desired screw

hole. A Drill Bitis used or preparing the holes or

the 3.8 Cancellou Locking screw(Figure 7).

The depth o each hole is determined using the

color-coded drill, but they may also be veried with

the more traditional Depth Gauge(Figure 8).

The 3.8mm Cancellous Locking Screws areprovided in lengths between 20mm and 56mm, in

3mm increments (Table 2).

The Tapered Drill Guide Tube is removed and theappropriately sized 3.8mm Cancellous Locking

Screw is inserted. A Ratcheting screw Driver isincluded in the instrument set to acilitate the

placement and tightening o the screws. The Torque

Liiting Adapter should be used when tighteningthe screws (Figure 9).

The aorementioned steps are then repeated or

placing each 3.8mm Locking Cancellous Screw inthe proimal portion o the plate.

TABLE 2 Cr-cdd Ccu lckig scrw


3.8

20 Black

23

26 Orange

29

32 Blue

35

38 Red

41

44 Green

47

50 Yellow

53

56 PurpleThread the 5.5 Threaded Drill Guide Tube into

figure 9

Placing Cancellous

Locking Screw

figure 8Screw Depth Verifcation

figure 7

Preparing or Cancellous

Locking Screws


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a) With Jig

b) Without Jig

the central hole or preparation o the 6.5Cancellou Locking screw. The 5.5 Drill Bit isused and the depth is determined with the color-

coded drill or the traditional Depth Gauge. The

5.5mm Drill Bit is cannulated, so i a K-wire wasused or the central hole location, it can be let in

place to target the drill (Figure 10).

The 6.5mm Cancellous Locking Screws areprovided in lengths between 32mm and 56mm, in

3mm increments (Table 3).

TABLE 3 Cr-cdd Ccu lckig scrw


6.5

32 Blue

35

38 Red

41

44 Green

47

50 Yellow

53

56 Purple

IMPlanTInG loCKInG blaDeA Blade Oteotoe is provided to penetratethe outer corte o the humerus. As the Blade

Osteotome is inserted into the humerus, thelasermarked lines are used to determine the

depth and corresponding blade length. The Blade

Osteotome can be used with or without the HeightTargeting Jig.

Note: The Blade Osteotome has lasermarked lines

on both sides corresponding to Jig or No Jig(Figure 11).

figure 10

Preparing Central Hole or Locking Screw

figure 11

Preparing or Locking Blade

c) Laser Markings or Each


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10

figure 15

Preparing Cortical

Locking Screws

The depth and corresponding blade length canalso be determined as i placing a locking screw,

using the Drill and Drill Guide as shown in Figure 7.

The Locking Blade are provided in lengthsbetween 25mm and 55mm, in 5mm increments

(Table 4).

TABLE 4 bd lgth d Thick

Thick (mm) lgth (mm)

2

2530

35

40

45

50

55

The Locking Blade is attached to the Locking BladeInserter and then impacted into position (Figure

12).

Once the Locking Blade is in the proper position,attach the Blade Holder to provisionally hold

the Blade in place. Then insert the two Blade

Locking screw, using the Ratcheting Handle and

Screwdriver (Figure 13).

Note: The Blade Locking Screws should betightened down slowly, alternating between each

side. The Torque Limiting Adapter should be used

when tightening the screws.

Note: In some cases, it may be useul to ll themetaphyseal void with Optecure+ccc, calcium

phosphate cement or other void ller. The centralhole o the plate allows or the insertion o these

FDA-cleared products through a syringe (Figure14). It is recommended that the bone substitutes be

delivered under fuoroscopy to veriy that none o

the product is leaving the racture site. I electing todo this, do not insert a 6.5mm Cancellous Locking

Screw (See Figure 10). I a bone-void ller isdelivered into the central hole, it is recommended

this step be carried out ater the insertion o

distal Cancellous Screws or Blade/Blade LockingScrews. The Central Hole Funnel, Graft Impactor

andSyringe Attachmentare provided to assist indeploying these void llers.

PlaCInG DIsTal CoRTICal loCKInG sCReWsFor appropriate placement o the 3.8 CorticalLocking screw, screw the Threaded 2.8mm or

3.3mm Drill Guide directly to the plate (Figure 15).

The 2.8mm or 3.3mm Drill Bit is used and thedepth o each hole is determined using the color-

coded drill. The Depth Gauge may also be usedto accurately veriy the screw length. Bicortical

ation is recommended (Figure 16).

figure 12

Placing Locking Blade

figure 13Placing Blade Locking

Screws

figure 14

Filling Voids with Grat

(optional)


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aPPlYInG sUTURes To x PlaTeThere are three locations on the plate that will allow

sutures to pass through the plate. Heavy braided,non-absorbable sutures are recommended or

attaching sot tissue or bony ragments. Sutures

may be passed once the plate is ed to thehumerus (Figure 17).

WoUnD ClosUReThe wound is closed in layers over a suction drain

with braided non-absorbable sutures to preventormation o hematoma

PosT-oPeRaTIVe ReHabIlITaTIonSuction drains and antibiotic prophylais aremaintained or at least 24 hours. Most patients nd

it more comortable to sleep with the head o thebed elevated approimately 30 degrees. Shoulder

mobilization begins on post-operative day onewith passive range o motion allowed to the limits

determined at the conclusion o surgical repair

With stable anatomic restoration o the proimalhumerus, ull range o shoulder motion typically is

restored.

Active abduction, orward feion and rotationare limited until si weeks ater surgery when the

tuberosities have united. However, active motionat the elbow, wrist and hand is allowed on post-

operative day one. Isometric muscle strengthening

o the deltoid, biceps and triceps also should bestarted at this time to avoid pseudosubluation

o the glenohumeral joint. When discharged romthe hospital, patients continue their regimen on an

outpatient basis.

Patients usually are seen post-operatively at weeks

two, our, eight, 12 and 26. Radiographic ollow-up includes a shoulder trauma series including

scapular AP, scapular lateral and aillary viewsto assess healing, tuberosity position, racture

settling and the development o osteonecrosis.

IMPlanT ReMoValIn the event that the patient must be revised and

the implants must be removed, the RatchetingHandle and Screw Drivers are used. Unlock all o

the screws rom the plate rst beore removingthem completely rom the bone.

To remove the Locking Blade, the screws are

removed with the Ratcheting Handle and ScrewDriver. The Blade Inserter is used to etract the

Blade. A slap-hammer may be attached to theBlade Inserter to provide more orce i necessary(Figure 18).

figure 16

Placing Cortical Locking Screws

figure 17

Placing Sutures

figure 18

Blade Removal


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Compression ScrewsLocking ScrewsCortcal Screws

Diameter Length Color

20 Black

23

26 Orange

29

32 Blue

3.8

Humeral Blades

Thickness Length

25

30

35

40

45

50

55

2

Wi dth Length Hol es Thi ckness

80 2

115 4

150 6

22.4 3.8

Cancellous Locking ScrewsDiameter Length Color Diameter Length

20 Black 32 Blue

23 35

26 Orange 38 Red

29 41

32 Blue 44 Green

35 47

38 Red 50 Yellow

41 53

44 Green 56 Purple

47

50 Yellow

5356 Purple

3.8 6.5

Blade Locking Screw

LengthLength

Length

Diameter

Length

Length

Thickness

Thickness

Proximal Humerus Fracture Plates

Width

sYsTeM sPeCIICaTIons

All dimensions are in millimeters. All implants are 316L stainless steel.


15/20

13

Prxim Humru rctur Pt

340-01-01 Fracture Plate, 80mm, Let

340-02-01 Fracture Plate, 80mm, Right340-01-02 Fracture Plate, 115mm, Let

340-02-02 Fracture Plate, 115mm, Right

340-01-03 Fracture Plate, 150mm, Let

340-02-03 Fracture Plate, 150mm, Right

6.5mm Ccu lckig scrw

340-65-32 6.5mm Locking Screws, Cancellous, 32mm





340-65-47 6.5mm Locking Screws, Cancellous, 47mm340-65-50 6.5mm Locking Screws, Cancellous, 50mm



3.8mm Ccu lckig scrw

340-38-20 3.8mm Locking Screw, Cancellous, 20mm






340-38-38 3.8mm Locking Screw, Cancellous, 38mm340-38-41 3.8mm Locking Screw, Cancellous, 41mm






3.8mm Crtic lckig scrw

340-40-20 3.8mm Locking Screw, Cortical, 20mm


340-40-26 3.8mm Locking Screw, Cortical, 26mm340-40-29 3.8mm Locking Screw, Cortical, 29mm


eQUInoXe IMPlanT sCoPeCtg numr Prt Dcripti


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eQUInoXe IMPlanT sCoPeCtg n. Prt Dcripti

3.8mm Crtic Cmpri scrw

340-41-20 3.8mm Screw, Cortical, Compression, 20mm

340-41-23 3.8mm Screw, Cortical, Compression, 23mm340-41-26 3.8mm Screw, Cortical, Compression, 26mm



lckig Humr bd340-00-25 Humeral Blade, 25mm

340-00-30 Humeral Blade, 30mm






Humr bd lckig scrw340-00-00 Blade Locking Screw


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eQUInoXe x PlaTe InsTRUMenT lIsTInG

Ctg n. Prt Dcripti

341-01-00 Torque Limiting Adapter

341-01-01 Targeting Jig Handle

341-01-10 Height Targeting Jig, Let

341-02-10 Height Targeting Jig, Right

341-01-20 Blade Inserter

341-01-21 Blade Osteotome

341-01-22 Blade K-Wire Guide

341-01-23 Blade Holder, Let

341-02-23 Blade Holder, Right

341-01-25 Blade Slap Hammer

341-01-28 2.8mm Drill Bit



341-01-38 T-10 Screw Driver

341-01-65 T-25 Screw Driver

341-01-41 Screw Depth Gauge


18/20

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eQUInoXe InsTRUMenT lIsTInG

Ctg n. Prt Dcripti

341-01-70 Central Hole Funnel

341-01-71 Syringe Attachment

341-01-72 Grat Impactor

341-02-28 Threaded Drill Guide Tube, 2.8mm



341-03-38 3.3mm Tapered Drill Guide Tube

341-04-38 Compression Screw Drill Guide

341-04-65 K-wire Guide, 6.5mm

341-05-38 K-wire Guide, 3.8mm

341-07-80 Ratcheting Screw Driver

341-35-00 1.6mm x 150mm Kirschner Wire

341-41-00 Equinoxe Fracture Implant Tray


19/20

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341-41-01 Equinoxe Fracture Plate 3.8mm Screw Caddy

341-41-02 Equinoxe Fracture Plate 6.5mm Screw Caddy

341-41-03 Equinoxe Fracture Plate Blade Caddy


20/20

352-377-1140

1-800-EXACTECH

www exac com

718-05-30 Rev. AEquinoe F Op. Tech. 0511

For additional device inormation, reer to the Exactech Shoulder Proximal Humerus Fracture Plate System Instructions or Use or a device description, indications,

contraindications, precautions and warnings. For further product information, please contact Customer Service, Exactech, Inc., 2320 NW 66th Court, Gainesville, Florida

32653-1630, USA. (352) 377-1140, (800) 392-2832 or FAX (352) 378-2617.

The products discussed herein may be available under dierent trademarks in dierent countries. All copyrights, and pending and registered trademarks, are property o

Exactech, Inc. This material is intended for the sole use and benet of the Exactech sales force and physicians. It should not be redistributed, duplicated or disclosed

without the express written consent o Exactech, Inc. 2011 Exactech, Inc.

Exactech is proud to have oices and distributors around the globe.

For more inormation about Exactech products available in your country, please visit www.exac.com

718-05-30_RevA_Equinoxe_FxPlate_OpTech

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Transcript of 718-05-30_RevA_Equinoxe_FxPlate_OpTech