Technique Guide Lapidus Arthrodesis System HVA Angle IMA Angle The AlignMate Lapidus Arthrodesis System features low-profile, anatomically pre-contoured Bone Plates with either a combination of locking and non-locking holes or all-locking holes for primary or revision cases.
Description The AlignMATE Lapidus Arthrodesis System consists of bone plates and bone screws (locking, non-locking and interfragmentary), which are intended to be used for surgical fusion or arthrodesis between two bone segments (ex. 1st metatarsal-cuneiform fusion as in a Lapidus procedure). All implant components are manufactured from implant grade titanium alloy. Materials Bone Plates: Bone Screws: Surgical Instruments: Titanium Alloy (Ti-6Al-4V) Titanium Alloy (Ti-6Al-4V) Medical Grade Titanium, Stainless Steel and High Temperature Plastics Indications For Use The AlignMATE Lapidus Arthrodesis System is intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities. Patient Selection Factors to be Considered Include: 1. Failure of previous conservative treatment options in correcting deformity and achieving pain relief. 2. Adequacy of bone stock to support implant components. 3. Patient s age indicative of skeletal maturity. 4. Functionality and/or stability of patient s musculotendinous system. 5. Patient s overall well-being, including the ability and willingness to follow pre and post-operative treatment regimen. Contraindications Absolute Contraindications Include: 1. Previous or current infection at or near the implantation site. 2. Pre-existing conditions such as limited blood supply that may significantly affect the healing response. 3. Patients having malignant primary or metastatic tumors that may preclude adequate bone support or screw fixation. 4. Patients with known allergies or hypersensitivity to implant grade titanium alloy typically used in prosthetic devices. Relative Contraindications Include: 1. Poor bone quality or quantity that may lead to inadequate stabilization/fusion of the joint complex. 2. Metabolic disorders that may impair the formation or healing of bone. 3. Infections at remote sites, which may spread to the implant site. 4. Rapid joint destruction or bone resorption visible on roentgenogram. 2
Surgical Technique 1. Expose the 1 st metatarsal-cuneiform (MC) joint following a lateral release at the 1st metatarsal-phalangeal (MTP) joint. Decorticate the base of the 1st metatarsal taking care to remove only the cartilage. Ensure that the cut is perpendicular to the long axis of the metatarsal. 2. Reduce the deformity in all three planes. A k-wire can be used as a joystick to correct frontal plane deformity to align the sesamoids under the 1st metatarsal head. Transverse plane correction can be achieved by a medial to lateral squeeze of the metatarsal. Confirm sagittal plane correction by ensuring full dorsiflexion of the hallux. Perform a second decortication of the medial cuneiform ensuring that the cut is parallel to the surface of the first metatarsal base. 3. Subchondral drilling of the decorticated joint surfaces can now be performed with a small drill bit. Reduce the joint and maintain the desired triplanar correction using a temporary k-wire. 3
4. Select the appropriate side (right or left), large or small Bone Plate based on the patient anatomy. Temporarily fixate the Bone Plate to the bones using Tack Pins, making sure to align the laser line on the Bone Plate with the 1 st MC joint line. Insert a Tack Pin in any one or both of the distal bone plate holes to fixate the bone plate to the metatarsal bone. Insert another Tack Pin on the proximal end of the pin slot to fixate the Bone Plate to the cuneiform bone. 5. Load the Compression Clamp on the proximal tack pin and any one of the distal Nubbins. Compress the 1 st MC joint. 4
6. Create pilot holes through the proximal Bone Plate hole using either a drill pin or a tack pin. Remove the proximal nubbins and discard them. Measure the proximal, superior bone screw length required using the Depth Gauge instrument. 7. Insert a non-locking screw. 5
8. Similarly, measure and insert a Locking Bone Screw in the proximal, inferior bone plate hole. Note: Based on preference, the surgeon can choose to insert either a locking or a non-locking Bone Screw in either of the proximal bone plate holes. Remove the compression clamp and the proximal tack pin from the pin slot. 9. Place the Interfragmentary (IF) Guide over the distal bone plate nubbins. Insert a Guide Pin through the IF Guide s pin slot and across the 1 st MC joint. Use fluoroscopy to confirm that the tip of the Guide Pin is flush with the inferior surface of the cuneiform bone. 6
10. Remove the IF Guide and place the IF Depth Gauge over the Guide Pin to determine the IF screw length required. 11. Remove the IF Depth Gauge. Create a pilot hole using the cannulated Drill Pin over the Guide Pin. The countersink instrument may now be used to create a recess in the metatarsal bone for flush placement of the IF screw head. 7
12. Remove the Drill Pin but leave the Guide Pin in place. Insert the cannulated screw over the Guide Pin and implant using the cannulated Screw Driver. Note: Based on surgeon preference, Step 5 (use of the compression clamp) can be skipped and steps 9 through 12 can be performed prior to Step 6. 13. Complete the implantation procedure by creating pilot holes, discarding the nubbins, followed by measuring and inserting either locking or non-locking bone screws in the distal bone plate holes. 8
ORDERING INFORMATION PLATES 9B00-100L Bone Plate, Left 39 mm 9B00-100R Bone Plate, Right 39 mm 9B00-200L Bone Plate, Left 34 mm 9B00-200R Bone Plate, Right 34 mm INTERFRAGMENTARY SCREWS 9B01-5036 Diameter 4.0 mm x 36 mm 9B01-5038 Diameter 4.0 mm x 38 mm 9B01-5040 Diameter 4.0 mm x 40 mm 9B01-5042 Diameter 4.0 mm x 42 mm 9B01-5044 Diameter 4.0 mm x 44 mm 9B01-5046 Diameter 4.0 mm x 46 mm 9B01-5048 Diameter 4.0 mm x 48 mm 9B01-5050 Diameter 4.0 mm x 50 mm INSTRUMENTS 9F00-1000 Instrument Kit, Fusion Plate - Reusable 9B07-1000 Pin Kit, AlignMATE - Single Use, Disposable 9B07-2000 Driver Kit, AlignMATE - Single Use, Disposable NON-LOCKING SCREWS 4F01-2008 Non-Locking Screw, Ø 3.0 mm x 8 mm 4F01-2010 Non-Locking Screw, Ø 3.0 mm x 10 mm 4F01-2012 Non-Locking Screw, Ø 3.0 mm x 12 mm 4F01-2014 Non-Locking Screw, Ø 3.0 mm x 14 mm 4F01-2016 Non-Locking Screw, Ø 3.0 mm x 16 mm 4F01-2018 Non-Locking Screw, Ø 3.0 mm x 18 mm 4F01-2020 Non-Locking Screw, Ø 3.0 mm x 20 mm 4F01-2022 Non-Locking Screw, Ø 3.0 mm x 22 mm 4F01-2024 Non-Locking Screw, Ø 3.0 mm x 24 mm BAILOUT SCREWS 9F01-5014 Non-Locking Screw, Ø 3.5 mm x 14 mm 9F01-5016 Non-Locking Screw, Ø 3.5 mm x 16 mm 9F01-5018 Non-Locking Screw, Ø 3.5 mm x 18 mm LOCKING SCREWS 4F01-1008 Locking Screw, Ø 3.0 mm x 8 mm 4F01-1010 Locking Screw, Ø 3.0 mm x 10 mm 4F01-1012 Locking Screw, Ø 3.0 mm x 12 mm 4F01-1014 Locking Screw, Ø 3.0 mm x 14 mm 4F01-1016 Locking Screw, Ø 3.0 mm x 16 mm 4F01-1018 Locking Screw, Ø 3.0 mm x 18 mm 4F01-1020 Locking Screw, Ø 3.0 mm x 20 mm 4F01-1022 Locking Screw, Ø 3.0 mm x 22 mm 4F01-1024 Locking Screw, Ø 3.0 mm x 24 mm 9
Warnings & Precautions Pre-operative and operative procedures, including knowledge of surgical technique, proper selection and placement of implant components are important considerations in the successful utilization of the AlignMATE Lapidus Arthrodesis System. The potential for success in joint fusion and/or fracture fixation is increased by proper implant selection. The patient s anatomy and indication will determine the size of the bone plate and screws to be used. The size and shape of human bones presents limitations on the size and strength of the implant components. To achieve desired outcomes with the AlignMATE Lapidus Arthrodesis System, pre-operative patient evaluation is extremely important. Patient s weight, occupation, activity level, mental condition, foreign body sensitivity and any degenerative diseases are important factors to consider. These conditions must be evaluated as a part of the pre-operative planning. The AlignMATE Lapidus Arthrodesis System implant components are manufactured from metal, and CANNOT be expected to withstand the range of motion, activity level and loads experienced by normal, healthy bone. These implants are intended to be used as a guide to normal healing, and not to replace normal body structure. It is very important to maintain the implant site in an immobilized state until bony union is confirmed via clinical or radiographic examination. Failure to do so will result in excessive and repeated stresses being placed on implant components, which can lead to bending or breaking of the implants due to normal metal fatigue. The presence of motion or forces across the fusion site in cases of delayed union or nonunion may lead to implant bending or breakage due to metal fatigue. All surgical implants are subjected to repeated stresses that can result in failure. The use of an implant should be avoided if excessive loading cannot be prevented at or near the implant site. Post-operative care is extremely important. The surgeon must warn the patient against noncompliance with post-operative instructions, which could lead to implant bending or breakage requiring a revision surgery and/or implant removal. Unless otherwise noted, the patient should employ adequate external support and restrict physical activities that may lead to stresses being placed on the implant components or allow motion at the fusion site and thus lead to delayed healing. An active, debilitated or demented patient who cannot properly utilize weight support devices may be at higher risk during post-operative rehabilitation. Accepted practices in post-operative care should be used. The patient is to be instructed and monitored to ensure a reasonable degree of compliance to post-operative instructions and activity restrictions. Excessive activity, impact, and weight gain have been implicated in the reduction of the benefit and service life of prosthetic devices. Correct implant handling is extremely important for successful outcomes. Implant components should not be bent, reverse bent, notched or scratched. All of these operations can produce defects in the surface finish and cause internal stress concentrations, which may become the focal point for eventual failure of the implant system. No other metallic implantable devices are to be used in conjunction with the AlignMATE Lapidus Arthrodesis System at the implant site. Doing so may compromise implant performance and patient safety. No implant component must be reused. The Align- MATE Lapidus Arthrodesis System implant components are Single Use devices that have not been designed to undergo or withstand any form of alterations, such as disassembly, cleaning or re-sterilization, after single patient use. Reuse can eventually compromise implant performance and patient safety. Implant removal is at the sole discretion of the surgeon. Whenever possible and practical for the individual patient, the AlignMATE Lapidus Arthrodesis System implant components should be removed once their service as an aid to the healing process is accomplished, particularly in younger and more active patients. Great care must be taken while removing the implant components. The AlignMATE Lapidus Arthrodesis System should be inspected by surgeon or surgical staff prior to use for any signs of wear or damage. Any discrepancies, damages or other issues with the packaging, labeling or implant components should be reported and brought to the notice of the manufacturer. 10
Possible Adverse Effects Loosening, bending, cracking or fracture of the bone plates and bone screws attributable to malunion, nonunion or osteoporosis. Loss of anatomic position with malunion or nonunion with rotation or angulation. Infection, both deep or superficial, or allergic reaction. Material sensitivity reactions. Implantation of foreign material in tissues can result in histological reactions. Particulate wear debris and mild tissue discoloration from metallic components have been noted in other prosthetic devices constructed from similar materials. Some types of wear debris have been associated with osteolysis and implant loosening. Embolism Tissue reactions such as macrophage and foreign body reaction at or near implant site. Fretting or crevice corrosion can occur at the interface of bone plates and bone screws. Fatigue fracture of the implants as a result of bone resorption around the implant components. Intraoperative or postoperative bone fracture. Post-operative pain or incomplete resolution of pre-operative symptoms. Sterility Bone Plates The AlignMATE Lapidus Arthrodesis System s bone plate with pre-assembled nubbins, and IF guide, are packaged together and provided STERILE. They are sterilized by exposure to gamma irradiation. Do not resterilize any components. Do not use if packaging is opened or damaged. Do not use if beyond expiration date. For Single Use Only. Note: Pre-assembled nubbins and IF guide are for guidance purposes only. In accordance with the surgical technique, the nubbins and IF guide are to be disassembled from the bone plate and disposed after intended use. IF Bone Screw The AlignMATE Lapidus Arthrodesis System s Interfragmentary or IF Bone Screws are individually packaged and provided STERILE. They are sterilized by exposure to gamma irradiation. Do not resterilize any components. Do not use if packaging is opened or damaged. Do not use if beyond expiration date. For Single Use Only. Pin Kit and Driver Kit The AlignMATE Lapidus Arthrodesis System s guide pin, drill pin and tack pins i.e. the Pin Kit, and the cannulated drill pin and screw driver i.e. Driver Kit, are packaged and provided STERILE. These are sterilized by exposure to gamma irradiation. Do not resterilize any components. Do not use if packaging is opened or damaged. Do not use if beyond expiration date. For Single Use Only. Dispose after intended use. Instrument Kit The AlignMATE Lapidus Arthrodesis System is to be used with CheckMATE instrument kit. Remove and discard any plastic caps or tip protectors before cleaning and sterilizing implants and instruments. Cleaning by hand rather than by mechanical cleaning will prolong the life of the implants and instruments. Clean all crevices, flutes, and cannulations of all debris, using a soft bristle brush or cleaning stylet. Remove all traces of blood or other residues immediately. Do not allow these to dry. Implants and instruments should be cleaned while submerged in warm water with an appropriate neutral ph detergent. Always follow the manufacturer s instructions when preparing and using detergents. Do not use steel brushes as they can accelerate wear and corrosion of the implants and instruments. Rinse implants and instruments thoroughly with distilled water. Dry implants and instruments immediately after cleaning. Sterilization Recommended parameters for steam sterilization are as follows: Cycle Temperature Minimum Exposure Time Vacuum 270 F/ 132 C 4 minutes Gravity 250 F/ 121 C 30 minutes Recommended dry time is 30 minutes. Parameters may vary based on manufacturer, installation or maintenance of sterilization equipment. On-going testing must be performed by the user to confirm inactivation of all forms of microorganisms. Sterilizing in liquid solutions is not recommended. Do not sterilize at temperatures greater than 275 F/ 135 C. Caution Federal Law (USA) restricts this device to sale by or on the order of a physician. 11
CheckMate Instrumentation PHALANGEAL REAMER, METATARSAL REAMER, COUNTER SINK SMALL SMALL CUTTER INTERFRAGMENTARY SCREW CADDY ELEVATOR AIMER METATARSAL REAMER, LARGE PHALANGEAL REAMER, LARGE TOE PLATE BENDERS COMPRESSION CLAMP DEPTH GAUGE HOOK HEXALOBE DRIVER SCREW PICK UP SLEEVE DEPTH GAUGE HOUSING DRIVER HANDLE For more information, visit our website: www.arthrosurface.com This pamphlet and information is intended for markets where regulatory approval has been granted. 12 28 Forge Parkway Franklin, MA 02038 1 508 520 3003 fax: 1 508 528 3785 PN 4001-3015 REV B This product is covered by one or more of U.S. Patent Nos. 6,520,964; 6,610,067; 6,679,917 and other patents pending. AlignMate is a trademark of Arthrosurface, Inc. U.S. 2017 Arthrosurface, Inc. All rights reserved. Printed in U.S.A.