SpeedTip CCS 5.0, 7.0

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SURGICAL TECHNIQUE STEP BY STEP SpeedTip CCS 5.0, 7.0 Cannulated Compression Screws APTUS

2 SpeedTip CCS 5.0, 7.0 Cannulated Compression Screws

SpeedTip CCS 5.0, 7.0 Cannulated Compression Screw 3 SpeedTip CCS 5.0, 7.0 Cannulated Compression Screws Contents 4 5 Technology, Screw Features 6 General Systems Application 5.0, 7.0 7 11 Surgical Technique Cannulated Compression Screws For further information regarding the APTUS product line see: www.medartis.com/products Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis AG / Medartis Holding AG, 4057 Basel, Switzerland

4 SpeedTip CCS 5.0, 7.0 Cannulated Compression Screws Technology, Screw Features SpeedTip Polygonal geometry and HexaDrive Technology SpeedTip thread design: Screws can be inserted directly without pre-drilling Reduced risk of bone fragment displacement thanks to excellent cutting behavior Optimized cutting tip SpeedTip polygonal geometry Effortless insertion the polygonal tip pushes bone debris aside SpeedTip Standard screw Self-tapping screws due to precise and sharp thread profile Medartis thread Competitor thread HexaDrive technology: Secure connection between screw and screwdriver Increased torque transmission Simplified screw pick-up due to patented self-holding properties Contact surface for screw retention (red) Contact surface for torque transmission (blue)

SpeedTip CCS 5.0, 7.0 Cannulated Compression Screw 5 Innovative technologies and excellent thread properties Cannulated and self-drilling screw design Excellent purchasing properties and low insertion torque reduce the risk of bone fragment displacement Clinical benefits and screw features Substantially less effort required to insert screws due to: Optimized cutting geometry SpeedTip in the screw tip Precise and sharp thread SpeedTip in the screw head Tapered shaft SpeedTip in the screw head SpeedTip in the screw tip Self-drilling screw design: Optimized cutting geometry Less surgical steps Easy to use Extended thread area: Compression is possible also in case of reduced bone density Improved purchase in cortical and cancellous bone Tapered shaft Choice of different distal threads for interfragmentary treatment in a variety of indications Fully threaded screws: For the use as set screws Offer additional purchase in the bone (without compression effect)

6 SpeedTip CCS 5.0, 7.0 Cannulated Compression Screws General Systems Application 5.0, 7.0 Product Materials Medartis APTUS cannulated compression screws are made of titanium alloy (ASTM F136, ISO 5832-3). All of the titanium materials used are biocompatible, corrosion-resistant and non-toxic in a biological environment. K-wires are made of stainless steel (ASTM F 138); instruments are made of stainless steel, PEEK, aluminum or titanium. Indications Treatment of fractures, osteotomies and arthrodesis of bones with the appropriate screw size. Color Coding System Color Code APTUS 5.0 dark blue APTUS 7.0 turquoise Screws Implant screws have their own color: Gold implant screws: 5.0 Cannulated Compression Screw 7.0 Cannulated Compression Screw Contraindications Pre-existing or suspected infections at or near the implantation site Known allergies and / or hypersensitivity to foreign bodies See Instructions for Use www.medartis.com Insufficient or inferior bone quality to securely anchor the implant Patients who are incapacitated and / or uncooperative during the treatment phase The treatment of at-risk groups is inadvisable Growth plates are not to be blocked with plates and screws Notes In patients with Charcot Foot and / or other neuropathic diseases, the CCS 5.0 and CCS 7.0 are not to be used as stand-alone implants. They need to be used with supplemental fixation, such as additional screws and plates across the fused joints. CCS 5.0 and CCS 7.0 screws have a sharp thread and need to be picked up from the implant container by means of the screwdriver. Be cautious touching the screws directly. Screws are not to be positioned in the joint gap (exception: arthrodesis).

SpeedTip CCS 5.0, 7.0 Cannulated Compression Screw 7 Surgical Technique Cannulated Compression Screws Use of dark blue color coded instruments for CCS 5.0. Use of turquoise color coded instruments for CCS 7.0. Step 1A Connect the color coded protection sleeve to the cannulated handle with quick coupling AO, respectively AO Large. CCS 5.0: A-8000.23 + A-8000.20 CCS 7.0: A-8001.23 + A-8001.10 AO Coupling AO Large Coupling Step 1B For minimal invasive screw insertion respectively for soft tissue protection, slide the K-wire guide and the trocar into the protection sleeve. CCS 5.0: A-8000.23 + A-8000.24 + A-8000.25 CCS 7.0: A-8001.23 + A-8001.24 + A-8001.25

8 SpeedTip CCS 5.0, 7.0 Cannulated Compression Screws Step 2 Place the protection sleeve (A-8000.23, A-8001.23) onto the bone. In case the trocar (A-8000.24, A-8001.24) was used, pull it off with a slight turning and pulling movement. In case the K-wire guide loosens, it needs to be moved back. Step 3A Select the required K-wire diameter depending on screw size and verify its size in the container s measuring module. CCS 5.0: 1.6 mm CCS 7.0: 2.2 mm To ensure that the lengths of the screws to be used are assigned correctly, only original Medartis K-wires may be used. If alternative wires are used, the correct screw length selection cannot be assured! CCS 5.0: A-5040.42 (trocar) or A-5044.42 (thread) 1.6 mm x length 200 mm CCS 7.0: A-5040.74 (trocar) or A-5044.74 (thread) 2.2 mm x length 250 mm

SpeedTip CCS 5.0, 7.0 Cannulated Compression Screw 9 Step 3B Place the K-wire perpendicularly to the fracture or osteotomy line. Check the position of the K-wire by X-ray. Step 4 Remove the K-wire guide (A-8000.25, A-8001.25). Slide the depth gauge (A-8000.27, A-8001.27) over the K-wire until touching the bone. The value can be read from the end of the K-wire. The depth measuring gauge A-8000.27 is for CCS 5.0 (dark blue) and A-8001.27 is for CCS 7.0 (turquoise). 5.0 For K-wire length 200 mm 7.0 For K-wire length 250 mm

10 SpeedTip CCS 5.0, 7.0 Cannulated Compression Screws Step 5 Optional Pre-drill with the color coded twist drill over the K-wire and through the protection sleeve. CCS 5.0: A-8000.03 CCS 7.0: A-8001.01 Drill the first cortex with the color coded countersink over the K-wire and through the protection sleeve. CCS 5.0: A-8000.04 CCS 7.0: A-8001.02 The use of twist drills and / or countersinks is recommended in case of very hard bone. Step 6A Select a screw that is slightly shorter than the value assigned in Step 4 to allow for shortening through compression of the fracture gap. Pre-drilling Use of countersink This does not apply for fully threaded screws, as they do not create a compression. To remove the screws from the implant container, insert the appropriately color coded screwdriver vertically into the screw head of the desired screw. Then pick up the screw with axial pressure. CCS 5.0: A-8000.21 + A-8000.20 CCS 7.0: A-8001.11 + A-8001.10 The screw will not hold without axial pressure! Vertically extract the screw from the compartment. The screw is held securely by the blade. If self-retention between screwdriver and screw cannot be achieved despite being picked up correctly, the screw may have already been picked up before. This can lead to a permanent deformation of the self-retaining area of the HexaDrive inside the screw head. Tip: Screw pick-up from the implant container is eased by a slight counter clock movement. Step 6B Check the screw length and diameter against the scale of the measuring module. The screw length is read to the end of its head.

SpeedTip CCS 5.0, 7.0 Cannulated Compression Screw 11 When selecting the screw, it is essential that the distal thread is not positioned within the fracture gap, as otherwise no compression can be achieved. Fully threaded screws: As these screws do not compress, the thread can be positioned after reduction within the fracture gap. If compression of the fracture gap is desired, then a partially threaded screw has to be inserted first. Only afterwards a fully threaded screw is inserted for stabilization. Step 7 When inserting the screw, apply sufficient axial pressure in order to allow for proper cutting and good thread formation. Use the protection sleeve while inserting the screws. CCS 5.0: A-8000.23 CCS 7.0: A-8001.23 Step 8 Turn the screw until the screw head is completely inserted in the bone. Remove the K-wire. The blade shows 4 ring groups in the tip area for a rough orientation of the insertion depth relative to the soft tissue thickness when using the system without protection sleeve. The blade also shows one single ring in the shaft area when using the system with the protection sleeve. If the screw is completely anchored, this single ring is approximately positioned on the level of the end of the protection sleeve. The correct screw position and length always has to be checked by X-ray.

APTUS-01020001_v2 / 2016-06, Medartis AG, Switzerland. All technical data subject to alteration. HEADQUARTERS Medartis AG Hochbergerstrasse 60E 4057 Basel / Switzerland P +41 61 633 34 34 F +41 61 633 34 00 www.medartis.com SUBSIDIARIES Australia Austria France Germany Mexico New Zealand Poland UK USA For detailed information regarding our subsidiaries and distributors, please visit www.medartis.com