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KG 1- Instructions for Use

INDICATION FOR USE WARNINGS AND PRECAUTIONS
• It is important to read the Device Instructions for Use prior to
The KG 1 is intended to be used for the delivery of hydrated
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allograft or autograft to an orthopedic surgical site. operation.
• Use the Device prior to the ‘Use By” Date noted on the package
DEVICE DESCRIPTION label. CAUTION
The KG 1 is comprised of a 21.0 cm length rectangular syringe • Before use, inspect the Device and packaging to verify that no • Federal (USA) law restricts this device to sale by or on the order
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barrel for surgical site access and graft material delivery; a damage has occurred as a result of shipping and handling. Do of a physician.
compatible syringe plunger for pushing the bone graft material into not use damaged products. • Sterilized with ethylene oxide gas.
the operative site; and, an attachable funnel reservoir for loading • Medical professionals using the Device should be familiar with • Do not use if package is opened or damaged.
prepared material. The barrel has an 8.0 mm by 12.0 mm closed- the physiology and pathology of the selected anatomy and be • Reuse can result in patient injury through infection.
end tapered distal shaft with a pair of longitudinal bilateral ejection properly trained in the use of the Device.
holes at the distal end for material effusion into the surgical space. • The system should be used aseptically according to the surgical PREPARATION AND USE OF THE DEVICE
The barrel can be partially filled with 2.0 to 3.0 cc of flowable technique. 1. The Device is packaged with plunger inserted in the cannula,
material and refilled as needed in-situ using the attachable funnel. • The system components are not intended for fluid injection into ready to be inserted into the prepared, distracted disk space.
the circulatory system. Inspect the package prior to use.
KG 1 • Do not over-fill or attempt to pressurize the bony defect site, as 2. Remove from the sterile package, inspect and handle the
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this may lead to extrusion of the graft material beyond the site of Device components in accordance with aseptic techniques and
its intended application and damage to the surrounding tissues. per orthopedic surgical practice.
• Prior to use, confirm visual evaluation of the targeted site for 3. Distract the disk space with wedge dilators per the cage
bone graft delivery. manufacturers protocol. Maintain the distraction with
• When used for bone graft delivery ancillary to spinal fusion, the provisional contralateral pedicle screw fixation.
disk space should be distracted with wedge dilators per the Attention: A minimum of 8mm of distraction is necessary
instrumentation or implant cage manufacturer’s instructions. A to safely use the device.
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minimum of 8.0 mm of distraction is recommended for use of the 4. Try a sample of the graft material with the KG 1 to ensure
Device. flowability.
• Use only manual power when using the Device. Do not mallet. 5. Insert the plunger/stylet into the empty cannula without the
Never use electric power (or any other alternative power sources funnel and insert the complex into the disk space. Remove the
or instruments) in conjunction with the Device. stylet and attach the funnel.
• The Device is intended for single use only. Do not re-sterilize 6. Apply the graft material with thumb and finger pressure into the
and/or reuse. cannula. Push the plunger all the way down to expel the
graft material. If the disk space does not vent the air out of
Device Barrel, Plunger, Funnel Device Assembly HOW SUPPLIED the disk, remove the cannula and increase the size of the
annulotomy. Apply 2-3 ml of graft with each pass of the
Sterilization plunger. You will feel resistance of flow when the disk space
The KG 1 is supplied sterile in a peel-open package. In the event has filled up. Tapping on the plunger will expel residual graft,

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of damage to the sterile packaging retain the contents and notify avoid using a mallet.
the manufacturer. 7. Remove the stylet and funnel and directly observe the area

The KG 1 is packaged in double sterile barrier protective pouches around the annulotomy/ cannula interface to confirm that graft
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and sterilized by Ethylene Oxide, confirmed by the green material has not overflowed.
sterilization indicator on the package. 8. Remove cannula and insert cage per the manufacturer
recommendations
STORAGE 9. Discard the device with other disposables after single patient
00010-IFU Rev 5 The instruments should be stored in their original shipping use.
materials, in a cool dark place. Proper care should be taken to 10. Continue with the surgical procedure and instrumentation where
ensure that the instruments will not be damaged. indicated.

Instructions for Use 113015 Manufactured for: Kleiner Device Labs :: 999 Driver Way :: Incline Village, NV 89451 :: Tel: 650 720 4766, ext 805. Fax: 775.743.5418