orthodontic Bone anchor (oba) SYStem

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orthodontic Bone anchor (oba) SYStem Skeletal implants for the orthodontic movement of teeth SurgIcal technique

Table of Contents Introduction Orthodontic Bone Anchor (OBA) System 2 Indications and Contraindications 4 Surgical Technique Implanting a Screw Anchor 5 Implanting a Plate Anchor 8 Using Orthodontic Appliances with Plate Anchors 12 Product Information Instruments 13 Set List 14 Orthodontic Bone Anchor (OBA) System Surgical Technique DePuy Synthes CMF

orthodontic Bone anchor (oba) SYStem The Orthodontic Bone Anchor (OBA) System is a plate and screw system designed to be implanted intraorally and used as an anchor for orthodontic procedures. the plate anchor portion of the system consists of t-shaped plate anchors which are attached to the bone via 1.55 cm cortex screws and 1.85 mm emergency screws. the plate anchors are offered in various designs for attachment to the orthodontic device. the screw anchor portion of the system consists of 1.55 mm self-drilling and self-tapping screw anchors which incorporate a non-threaded gingival collar beneath the screw head which protects the soft tissue. It includes screw anchors, plate anchors, instruments, and a module case for storage and sterilization. Provides fixed anchorage for improved control of tooth movement compatible with a variety of orthodontic devices including archwires, elastics and springs allows immediate loading Plate anchors can be adapted to the patient s bony anatomy manufactured from commercially pure (cp) titanium and titanium alloy* for biocompatibility Plate anchor Profile of an archwire in a screw anchor Screw anchor Screw Anchors thread diameter of only 1.55 mm for placement between tooth roots two through-holes in screw head accept archwires with a cross section of up to 0.022 in. x 0.028 in. Shape of through-holes prevents unintended rotation of rectangular archwires nonthreaded 1.5 mm long gingival collar beneath the screw head protects soft tissue Self-drilling thread lengths of 6 mm and 8 mm, and self-tapping thread length of 10 mm groove in screw anchor head accepts elastics, wires, or springs 6 mm 8 mm 10 mm through-hole gingival collar * ti-6al-7nb 2 DePuy Synthes CMF Orthodontic Bone Anchor (OBA) System Surgical Technique

orthodontic Bone anchor (oba) System Plate Anchors allow placement away from tooth roots can be contoured and/or trimmed to conform to patient anatomy Implanted using up to five (5) self-drilling titanium screws for stability three design options Mesh Plate Anchor orthodontists can mount preferred dental bracket to anchors using uv-cure adhesive Bracket Plate Anchor Simulates orthodontic bracket and allows attachment of various orthodontic appliances 4-hole mesh plate anchor 4-hole bracket plate anchor 4-hole domed plate anchor Domed Plate Anchor allows attachment of archwires from three different vectors, or attachment of elastics or springs 5-hole mesh plate anchor 5-hole bracket plate anchor 5-hole domed plate anchor Plate Anchor Screws used to secure plate anchors to the bone diameter of 1.55 mm lengths of 4 mm, 6 mm, and 8 mm Self-drilling threads Plate Anchor Emergency Screws used if a plate anchor screw becomes loose upon insertion in the bone Slightly oversized diameter of 1.85 mm lengths of 4 mm, 6 mm, and 8 mm Self-tapping threads Orthodontic Bone Anchor (OBA) System Surgical Technique DePuy Synthes CMF 1

Indications and Contraindications Indications The Orthodontic Bone Anchor (OBA) System screw anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adolescents greater than age 12 and adults. The Orthodontic Bone Anchor (OBA) System plate anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adults. Contraindications The Orthodontic Bone Anchor (OBA) System is contraindicated: When cortical bone is less than 5 mm thick, or when there is insufficient quantity or quality of bone In deciduous or mixed dentition When active or latent infection is present In patients with an abnormal habit of mastication, as this may affect the retention and stability of the device after implantation These devices are intended for single use only and are provided NONSTERILE only. MR INFORMATION This device has not been evaluated for safety and compatibility in the MR environment. This device has not been tested for heating or migration in the MR environment. 4 DePuy Synthes CMF Orthodontic Bone Anchor (OBA) System Surgical Technique

Implanting a Screw Anchor 1 Locate the implantation site Choose the implantation site according to the treatment objective and the quality and quantity of bone. Confirm that the implantation site allows adequate clearance from the tooth roots. Choose the screw anchor with the appropriate thread length: 6 mm and 8 mm self-drilling or 10 mm self-tapping. Precaution: To avoid damage to anatomic structures, place implant away from tooth roots, tooth buds, vessels, nerves, and/or sinuses. In adolescent patients, care should be taken to avoid sutures and other areas and structures that are not fully developed. 2 Prepare the implantation site If desired, make a small incision at the implantation site and dissect through the soft tissue to the bone. Warnings These devices can break during use (when subjected to excessive forces or outside the recommended surgical technique). While the surgeon must make the final decision on removal of the broken part based on associated risk in doing so, we recommend that whenever possible and practical for the patient, the broken part should be removed. Instruments and screws may have sharp edges or moving joints that may pinch or tear user s glove or skin. Precautions Drill rate should never exceed 1,800 rpm. Higher rates can result in thermal necrosis of the bone, soft tissue burns, and an oversized hole to be drilled. The adverse effects of an oversized hole include reduced pullout force, increased ease of the screws stripping in bone, and/or suboptimal fixation. Always irrigate during drilling. Avoid drilling over nerve or tooth roots. Take care while drilling as to not damage, entrap, or tear a patient s soft tissue or damage critical structures. Be sure to keep drill clear of loose surgical materials. Handle devices with care and dispose worn bone cutting instruments in a sharps container. Orthodontic Bone Anchor (OBA) System Surgical Technique DePuy Synthes CMF 5

Implanting a Screw Anchor 3 Implant a 6 mm or 8 mm screw anchor Instruments 03.500.001 Screw Anchor Cruciform Screwdriver Blade, with Spring Holding Sleeve, short 311.007 Screwdriver Handle with hex coupling, large Screw anchor mounted on screwdriver blade with holding sleeve Optional instruments 03.500.006 1.25 mm Drill Bit, J-latch, 44.5 mm, 6 mm stop or 03.500.008 1.25 mm Drill Bit, J-latch, 44.5 mm, 8 mm stop Note: To implant a 10 mm self-tapping screw anchor, continue with Steps 4 5. Using the screw anchor cruciform screwdriver blade with spring holding sleeve, short and the screwdriver handle with hex coupling, load the screw anchor of the desired length and implant it until the distal lip of the screw anchor head sits on top of the soft tissue. If a pilot hole is desired, use the appropriate 1.25 mm drill bit with stop and a surgical power drill. Irrigate thoroughly to prevent overheating of the drill bit and bone. Notes For optimal retention, insert screw perpendicular to cortical bone Please see Page 5 for Warnings for Instruments and Precautions for Drill Bits 4 Drill a pilot hole for a 10 mm self-tapping screw anchor Instrument 03.500.010 1.25 mm Drill Bit, J-latch, 44.5 mm, 10 mm stop Before implanting a 10 mm self-tapping screw anchor, drill a pilot hole using the 1.25 mm drill bit with 10 mm stop and a surgical power drill. Irrigate thoroughly to prevent overheating of the drill bit and bone. Important: Always drill a pilot hole for the 10 mm self-tapping screw anchor. 6 DePuy Synthes CMF Orthodontic Bone Anchor (OBA) System Surgical Technique

Implanting a Screw anchor 5 Implant a 10 mm self-tapping screw anchor Instruments 03.500.001 Screw anchor cruciform Screwdriver Blade, with Spring holding Sleeve, short 311.007 Screwdriver handle with hex coupling, large Screw anchor mounted on screwdriver blade with holding sleeve using the screw anchor cruciform screwdriver blade with spring holding sleeve, short and the screwdriver handle with hex coupling, implant the 10 mm screw anchor until the distal lip of the screw anchor head sits on top of the soft tissue. Notes For optimal retention, insert screw perpendicular to cortical bone Please see Page 5 for Warnings for Instruments and Precautions for Drill Bits 6 Implant additional screw anchors repeat the preceding steps for additional screw anchors, as needed. Precaution: Due to clinical limitations associated with orthodontic tooth movement, the applied load should not exceed 300 grams. Orthodontic Bone Anchor (OBA) System Surgical Technique DePuy Synthes CMF 7

Implanting a Plate Anchor 1 Locate the implantation site Choose the implantation site according to the treatment objective and the quality and quantity of bone. Confirm that the implantation site allows adequate clearance from the tooth roots. Select plate design (mesh pad, bracket or domed). Consider in advance the reshaping and/or trimming of the plate that may be required to conform to the patient s bony anatomy. Precaution: To avoid damage to anatomic structures, place implant away from tooth roots, tooth buds, vessels, nerves, and/or sinuses. 2 Prepare the implantation site Make an appropriately sized incision where the plate anchor neck will protrude through the soft tissue, orienting the incision perpendicular to the long axis of the plate anchor neck, and dissect through the soft tissue to the bone. Make a subperiosteal pocket large enough to allow insertion of the plate anchor and implantation of the plate anchor screws. 8 DePuy Synthes CMF Orthodontic Bone Anchor (OBA) System Surgical Technique

Implanting a Plate Anchor 3 Reshape and/or trim the plate anchor Instruments 329.14 universal Bending Pliers, for 1.0 mm, 1.3 mm, 1.5 mm, 2.0 mm Plates 391.98 Plate Cutter, for 1.0 mm, 1.3 mm, 1.5 mm, 2.0 mm Plates The plate anchor may need to be reshaped and/or trimmed to conform to the patient s bony anatomy. If so, use the universal bending pliers and/or the plate cutter. The plate anchor has a T-configuration, but it may be trimmed to an L- or I-configuration if required. If desired, use the universal bending pliers to reshape the plate anchor neck where it will protrude through the soft tissue. Precaution: If contouring is necessary, avoid sharp bends, reverse bends, or bending the implant at a screw hole. Avoid notching or scratching the implant. These factors may produce internal stresses which may become the focal point for eventual breakage of the implant. Note: Please see Page 5 for Warnings for Instruments and for Precautions for Drill Bits. Orthodontic Bone Anchor (OBA) System Surgical Technique DePuy Synthes CMF 9

Implanting a Plate anchor 4 Implant the plate anchor screws Instruments 1.25 mm drill Bit, J-latch, 44.5 mm, with stop 03.500.004 4 mm 03.500.006 6 mm 03.500.008 8 mm 03.503.202 matrixmidface tm Screwdriver Blade, with hex coupling 311.007 Screwdriver handle with hex coupling, large choose the plate anchor screws of the appropriate length(s). make certain that they will avoid the tooth roots. While holding the plate anchor in the desired location in the subperiosteal pocket, use the matrixmidface screwdriver blade and the screwdriver handle with hex coupling to implant the first plate anchor screw. Notes For optimal retention, insert screw perpendicular to cortical bone If the plate anchor screw becomes loose in the bone, remove the screw and replace it with the appropriate length OBA titanium plate anchor emergency screw repeat this process for the remaining screws. It is recommended to use at least three (3) screws to secure the plate anchor. If pilot holes are desired, make one for each screw using the appropriate 1.25 mm drill bit with stop and a surgical power drill. Irrigate thoroughly to prevent overheating of the drill bit and bone. 10 DePuy Synthes CMF Orthodontic Bone Anchor (OBA) System Surgical Technique

Implanting a Plate Anchor 5 Confirm stability of plate anchor Irrigate the subperiosteal pocket until it is free of debris, and surgically close the incision. Confirm that the stability of the plate anchor is satisfactory. The plate anchor neck is malleable and can be adjusted if necessary. Orthodontic Bone Anchor (OBA) System Surgical Technique DePuy Synthes CMF 11

using orthodontic appliances WIth Plate anchors 6a Using bracket and domed plate anchors apply orthodontic devices directly to abutment on plate as desired. 6b Mounting orthodontic bracket to mesh pad plate anchor mount a standard orthodontic bracket to the mesh pad plate anchor using uv-cure adhesive. this will require the same uv-cure adhesive normally used to bond the orthodontic bracket to a tooth. apply the uv-cure adhesive directly to the top surface at the end of the mesh pad plate anchor and spread it evenly over the surface. add adequate adhesive to the mesh pad of the orthodontic bracket and firmly press the bracket onto the surface of the plate anchor, adjusting the orientation of the bracket as needed. excess adhesive may be wiped away from the sides and bottom of the mesh pad plate anchor. expose the area around the orthodontic bracket and mesh pad plate anchor to uv light, using an orthodontic uv light source. time the exposure per the recommendations of the adhesive and uv light source manufacturers. Precaution: Due to clinical limitations associated with orthodontic tooth movement, the applied load should not exceed 300 grams. 12 DePuy Synthes CMF Orthodontic Bone Anchor (OBA) System Surgical Technique

Instruments 03.500.001 Screw Anchor Cruciform Screwdriver Blade, with Spring Holding Sleeve, short 1.25 mm Drill Bit, J-latch, 44.5 mm 03.500.004 4 mm, stop 03.500.006 6 mm, stop 03.500.008 8 mm, stop 03.503.202 matrixmidface Screwdriver Blade, hex coupling, self-retaining, 76 mm 311.007 Screwdriver Handle with hex coupling, large 329.14 universal Bending Pliers, for 1.0 mm, 1.3 mm, 1.5 mm, 2.0 mm plates 391.98 Plate Cutter, for 1.0 mm, 1.3 mm, 1.5 mm, 2.0 mm plates Orthodontic Bone Anchor (OBA) System Surgical Technique DePuy Synthes CMF 11

Orthodontic Bone Anchor (OBA) Set (01.500.006) Module* 60.500.006 module for Orthodontic Bone Anchor (OBA) System 60.500.007 label Sheet, Orthodontic Bone Anchor Instruments 03.500.001 Screw Anchor Cruciform Screwdriver Blade, with Spring Holding Sleeve, short 1.25 mm Drill Bits, J-latch 03.500.004 4 mm stop, 44.5 mm 03.500.006 6 mm stop, 44.5 mm 03.500.008 8 mm stop, 44.5 mm 03.500.010 10 mm stop, 44.5 mm 03.503.202 matrixmidface Screwdriver Blade, hex coupling, self-retaining, 76 mm 311.007 Screwdriver Handle with hex coupling, large 329.14 universal Bending Pliers, for 1.0 mm, 1.3 mm, 1.5 mm, 2.0 mm plates, 2 ea. 391.98 Plate Cutter, for 1.0 mm, 1.3 mm, 1.5 mm, 2.0 mm plates Implants titanium OBA Screw Anchors, 10 ea. 04.500.006 6 mm length, self-drilling 04.500.008 8 mm length, self-drilling 04.500.010 10 mm length, self-tapping titanium OBA Plate Anchors, mesh pad design, 3 ea. 04.500.014 4 holes 04.500.017 5 holes titanium OBA Plate Anchors, bracket design, 3 ea. 04.500.012 4 holes 04.500.015 5 holes titanium OBA Plate Anchors, domed design, 3 ea. 04.500.013 4 holes 04.500.016 5 holes titanium OBA Plate Anchor Screws, self-drilling, 2 pkgs. of 5 ea. 04.500.024.05 4 mm length 04.500.026.05 6 mm length 04.500.028.05 8 mm length titanium OBA Emergency Screws, 2 ea. 04.500.034.01 4 mm length 04.500.036.01 6 mm length 04.500.038.01 8 mm length Also Available 03.500.002 Screw Anchor Cruciform Screwdriver Blade, with Spring Holding Sleeve, long 03.503.201 matrixmidface Screwdriver Blade, hex coupling, self-retaining, 52 mm 03.503.203 matrixmidface Screwdriver Blade, hex coupling, self-retaining, 96 mm For detailed cleaning and sterilization instructions, please refer to: www.synthes.com/cleaning-sterilization In Canada, the cleaning and sterilization instructions will be provided with the Loaner shipments. * only one screwdriver blade with holding sleeve will fit inside the module at a time. 11 DePuy Synthes CMF Orthodontic Bone Anchor (OBA) System Surgical Technique

Some devices listed in this Technique Guide may not have been licensed in accordance with Canadian Law and may not be for sale in Canada. Please contact your Sales Consultant for items approved for sale in Canada. Limited Warranty and Disclaimer: DePuy Synthes CMF products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed. WARNING: In the USA, this product has labeling limitations. See package insert for complete information. Rx Only Not all products are currently available in all markets. Manufactured by (United States): Synthes CMF 1302 Wrights Lane East West Chester, PA 19380 Telephone: (610) 719-5000 To order: (800) 523-0322 Fax: (610) 251-9056 Legal Manufacturer (Canada): Synthes (Canada) Ltd. 2566 Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) 567-0440 To order: (800) 668-1119 Fax: (905) 567-3185 www.depuysynthes.com DePuy Synthes CMF, a division of DOI 2014. All rights reserved. DSUS/CMF/0814/0169 8/14

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