Merete MetaFix Ludloff Plate Low Profile Locking Bone Plate System Surgical Technique and Ordering Information
- Content - Content 1. Description.................................................. 3 2. Intended Use................................................. 3 2.1 Benefits..................................................... 4 2.2 Indication................................................... 4 2.3 Contraindications............................................. 4 2.4 Warnings and Precautions....................................... 4 2.5 Adverse Effects............................................... 5 2.6 Please Note.................................................. 5 3. Surgical Technique............................................. 6 3.1 Incision..................................................... 6 3.2 Ludloff Osteotomy Cut.......................................... 7 3.3 Selection of Merete Ludloff Plate................................... 8 3.4 First K-wire Positioning..........................................9 3.5 Measurement of the Screw Length.................................10 3.6 Complete Ludloff Cut and Correction...............................11 3.7 Distal Non-Locking Screw.......................................12 3.8 Measurement of the Screw Length................................. 12 3.9 Tighten both non-locking cannulated dorsal screws.....................13 3.10 Drill Guide for Locking Screws................................... 14 3.11 Measurement for the Locking Screws...............................14 3.12 Measurement for the Locking Screw................................14 3.13 Fixation of the Locking Screws.................................... 15 4. Ordering Information..........................................17 Merete Technologies, Inc. (MTI) Page 2
- Description - Caution Federal Law restricts this device to sale by or on the order of a physician. 1. Description The Merete MetaFix Ludloff plate allows the surgeon to obtain RIGID LOW PROFILE fixation for Hallux Valgus correction using the familiar Ludloff osteotomy technique. Previous fixation with only two screws was inadequate and required non-weight bearing post-op care. With the Merete MetaFix Ludloff plate you achieve compression and a rigid stable fixation. The Merete MetaFix Ludloff plate is a patented designed plate with locking and non-locking holes. The straight section of the plate is placed dorsally on the metatarsal where the plate is fixed to the bone with two 3.0 mm Merete Cannulated PCS plate compression screws. First screw, located through the plate at the apex/rotation point of Ludloff cut and second non-locking screw is placed distal after cut completion and lateral rotation for correction. The screws can be angled up to 15 in the plate in order to run perpendicular to the osteotomy cut for compressing the osteotomy. Two 3.0 mm or 3.5 mm MetaFix LS locking screw are inserted from the medial side to gain angle stable locking fixation of the osteotomy and to allow early weight bearing. Three plate lengths are available (31 mm, 34 mm and 38 mm) for left and right. The low profile bone plates and screws are manufactured from Titanium alloy Ti-6Al-4V ELI. The patented Merete MetaFix Ludloff plate has been developed in collaboration with Steven K. Neufeld, M.D., Orthopedic Foot and Ankle Center of Washington. 2. Intended Use The Merete MetaFix Plate System is used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones. The Merete MetaFix Ludloff plate allows the surgeon to obtain RIGID LOW PROFILE fixation for Hallux Valgus correction using the Ludloff osteotomy technique. Merete Technologies, Inc. (MTI) Page 3
- Description - 2.1 Benefits Rigid low profile fixation for Hallux Valgus correction using the familiar Ludloff osteotomy technique Allows for early weight bearing post-op care compared to conventional screw fixation. AAOS peer reviewed Orthopedic Research Committee approved Biomechanical Weight Bearing study on file with Merete, available upon request. Non-locking dorsal to plantar screws fixed perpendicular to osteotomy achieve compression across the osteotomy with rigid fixation after osteotomy correction, transferring the weight bearing to the plate and not the osteotomy Proximal and Distal Locking screws provide rigid fixation after osteotomy correction, transferring the weight bearing to the plate and not the osteotomy. 2.2 Indication The Merete MetaFix Ludloff plate is indicated for the fixation of a Ludloff 1st Metatarsal Osteotomy for hallux valgus correction. 2.3 Contraindications Not for use in: Acute infections Osteoarthritis Primary chronical Polyarthritis Ostopereatric bone Inadequate skin, bone or neurovascular status Patients with high physical demands or Non-Compliant Patient Concerns 2.4 Warnings and Precautions This product is provided non-sterile and is for single use only. An internal fixation device must never be re-used. The device must be properly cleaned and sterilized before use. Prior to use examine device and check for proper functioning. The device is designed for use by surgeons experienced in the appropriate specialized procedures. It is the responsibility of the surgeon to become familiar with the proper techniques. Additional precautions include those applicable to any surgical procedure. In general, careful attention must be paid to asepsis and avoidance of anatomical hazards. For use in pediatric patients this product should not be placed across the growth plate. For the implantation of the Merete Locking Bone Plate System use only the original Merete Locking Bone Plate System Instruments. This product has not been evaluated for safety and compatibility in the MR environment and it has not been tested for heating or migration in the MR environment. Merete Technologies, Inc. (MTI) Page 4
- Description - 2.5 Adverse Effects The adverse effects associated with this device are the same as with any metallic internal fixation device. These include but not limited to the following: Delayed or non-union which may lead to breakage of the implant. Bending or fracture of the implant. Metal sensitivity, or allergic reaction to a foreign body. Pain, discomfort, or abnormal sensation due to the presence of the device. 2.6 Please Note For the implantation of the Merete MetaFix Ludloff plate system only the provided Merete MetaFix Ludloff instruments, MetaFix LS locking screws and Merete Cannulated PCS compression Screws should be used and the surgical instructions below followed. Merete MetaFix Ludloff plates, MetaFix LS locking screws and Merete Cannulated PCS are single-use products only and should not be reused. Merete Technologies, Inc. (MTI) Page 5
3. Surgical Technique The surgical technique presented here is used to demonstrate the fundamental procedure. Merete GmbH, as the manufacturer of these devices, does not practice medicine and does not recommend these or any other surgical techniques for use on a particular patient. The surgeon who performs any implant procedure is responsible for determining and utilizing the appropriate techniques for implanting a prosthesis in each individual patient. Merete GmbH is not responsible for selection of the appropriate surgical technique to be utilized for an individual patient. 3.1 Incision With a Medial based incision, the dorsal medial cutaneous nerve is protected in the dorsal flap and exposure to the metatarsal is achieved. A lateral release of the distal soft tissue should be performed by surgeon preference. Using the metatarsal cuneiform joint as a marker, begin the Ludloff osteotomy cut (as described in the literature) dorsally at the level of the metatarsal cuneiform joint but not further than 15 mm distal to the joint. The Osteotomy cut begins dorsally and obliquely extends at a 30 degrees angle ending proximal to the sesamoid complex (Figure 1). Figure 1: 30 degrees Ludloff Osteotomy NOTE: Surgeon may select to use a K-wire proximal at the starting point and distal at the ending point, both placed medially into the metatarsal. Merete Technologies, Inc. (MTI) Page 6
3.2 Ludloff Osteotomy Cut Complete only 3/4 of the Ludloff Osteotomy cut (Figure 2 and Figure 3). Figure 2 Ludloff Osteotomy cut proximal distal Figure 3 Complete only 3/4 of the cut Merete Technologies, Inc. (MTI) Page 7
3.3 Selection of Merete MetaFix Ludloff plate Select appropriate Merete MetaFix Ludloff plate length, 31 mm, 34 mm or 38 mm. Figure 4 For pre-determined very severe IM angle corrections, surgeon may wish to use the Merete bending pliers. Surgeon may bend the proximal curvature in the plate to decrease this plate angle, to allow for greater corrections if needed. This is completed by bending the proximal screw hole location up to decrease this curvature. IMPORTANT NOTES Plate is designed with less thickness at the corner curvature bends (from dorsal to locking screw locations). This allows to bend the plate. Please ensure that the taped holes were not damaged. Merete Starter Screw (Ref. CK00025). The Starter Screw is for use at the proximal/dorsal non-locking screw location. As indicated on the surgery technique 3.5, once the first K-wire is positioned, surgeon may decide to use the Starter Screw if the surgeon feels he wants the option to remove the Ludloff plate for bending purposes after the correction takes place. The Starter Screw is cannulated and has a 2.5 mm diameter hex. It slides over the K-wire, is screwed into position across the osteotomy, but not the full length of the desired screw measurement. It acts as the pivot point for the lateral correction of the ludloff osteotomy after final osteotomy cut. The Starter Screw allows the surgeon the option of removing the plate for bending purposes, yet maintaining the correction and position of the osteotomy. Once correction is achieved, surgeon places distal/ dorsal K-wire in position. Surgeon may remove plate, bend appropriately and then place plate in position and implant the recommended 3.0 mm Merete Cannulated PCS plate compression screw dorsal. Merete Technologies, Inc. (MTI) Page 8
3.4 First K-wire Positioning Holding the plate manually or fixating the plate with the temporary K-wire hole to the metatarsal, run a 1.0 mm K-wire (length 150 mm) through the plate in the non- locking proximal/dorsal screw hole by using the K-wire drill guide Ref. AC10020 (Figure 5). The K-wire will guide the 3.0 mm Merete Cannulated PCS plate compression screw and is placed perpendicular across the osteotomy. The K-wire guide allows for centered placement of the K-wire for the dorsal screws and prevents an angle of greater than 15 degrees, ensuring the dorsal non-locking cannulated screws will sit flush to the plate. Surgeon should check K-wire position under C-arm to ensure K-wire does not interfere with the metatarsal-cuneiform joint. The K-wire has to be justified at the opposite cortical bone to find the correct screw length distal proximal Figure 5 NOTE: Plate will not fit perfectly to the pre-operative bone. The plate is designed to fit after you have completed your osteotomy cut and correction. Merete Technologies, Inc. (MTI) Page 9
3.5 Measurement of the Screw Length Measure appropriate screw length with depth gauge AC14150 (Figure 6). Figure 6 Insert the first 3.0 mm Merete Cannulated PCS plate compression screw over the K-wire across the osteotomy. Do not tighten the screw as this screw is your pivot point for the Ludloff Osteotomy. This screw length is normally 22 mm up to 28 mm long. (Figure 7) proximal Figure 7 distal Merete Technologies, Inc. (MTI) Page 10
NOTE: The 3.0 mm Merete Cannulated PCS plate compression screws are self-drilling/tapping. An optional 2.0 mm cannulated drill bit is available for excessive hard bone or if surgeon wishes to pre-drill before placement of the screw. proximal distal Figure 8 3.6 Complete Ludloff Cut and Correction Complete remainder of Ludloff Osteotomy cut with first screw and plate in position. Shift the distal metatarsal laterally to achieve correction (Figure 8). * Surgeon may wish to use a towell clamp or freer, to hold this corrected metatarsal position for placement of the 2nd distal/dorsal non-locking K-wire for the screw (Figure 9). Figure 9 Merete Technologies, Inc. (MTI) Page 11
3.7 Distal Non-Locking Screw Figure 10: Ludloff hallux valgus correction Once correction has been achieved and checked under C-arm, insert the second 1.0 mm K-wire for the distal metatarsal fragment. Insert the second 1.0 mm K-wire for the distal 3.0 mm Merete Cannulated PCS plate compression screw, perpendicular to the osteotomy by using the K-wire drill guide AC10020. NOTE: If not using the C-arm, surgeon should visually make sure that the K-wire has proper purchase through the bottom metatarsal bone in order to ensure bi-cortical fixation of the distal 3.0 mm Merete Cannulated PCS screw and straight placement from dorsal to plantar. 3.8 Measurement of the Screw Length Measure appropriate screw length with depth gauge AC14150 and insert the distal 3.0 mm Merete Cannulated PCS screw over the K-wire across the osteotomy. This screw length is normally 16 mm up to 20 mm long. Merete Technologies, Inc. (MTI) Page 12
3.9 Tighten Both Non-Locking Cannulated Dorsal Screws proximal Figure 11 distal Merete Technologies, Inc. (MTI) Page 13
3.10 Drill Guide for Locking Screws Thread the 2.0 mm drill guide (Ref. FH10045) into the distal screw location and the 2.5 mm drill guide (Ref. FH10046) into the proximal screw location (Figure 12). distal proximal Figure 12: Drill guide placement for locking screws after fixation with the two dorsal compression screws 3.11 Drill For The Locking Screws Pre-drill completely through opposite cortex. 2.0 mm drill bit distally and 2.5 mm drill bit proximally. 3.12 Measurement For The Locking Screws Measure appropriate length for each locking screw with sliding depth gauge (Ref. AC00007). Distal 3.0 mm MetaFix LS locking screw length is normally 12 mm up to 18 mm long. Proximal 3.5 mm MetaFix LS locking screw length normally measures 18 mm to 24 mm long. Merete Technologies, Inc. (MTI) Page 14
distal proximal Figure 13 3.13 Fixation of the Locking Screws Drive each locking screw into position so they are locked and flush to plate. The screw driver axis should be exactly aligned with the axis of screw and screw hole. The screw should easily thread and lock into the plate. NOTE: Do not use too much force when tightening the screw. If resistance is met, slightly back out screw, realign both screw and screw driver and turn the screw in again. The screw head should end up flush to the plate. The screws should also penetrate the opposite cortex to achieve bicortical fixation. proximal distal Figure 14 Surgeon should check correction under C-arm and saw off the remaining bone from the ludloff correction procedure and close site. Merete Technologies, Inc. (MTI) Page 15
Figure 15: Ludloff hallux valgus correction pre- and post-operation Merete Technologies, Inc. (MTI) Page 16
- Ordering Information - 4. Ordering Information MetaFix Ludloff plate, non-sterile Length [mm] 31 34 38 Right FH01131 FH01134 FH01138 Left FH02131 FH02134 FH02138 Locking and Non-Locking Screws, non-sterile Length [mm] Metafix LS locking screw 3.0 mm Metafix LS locking screw 3.5 mm Merete Cannulated PCS plate compression screw 3.0 mm (1.0 mm K-wire) 12 14 16 18 20 22 24 26 28 30 32 FH30012 FH30014 FH30016 FH30018 FH30020 FH30022 FH30024 FH30026 FH30028 FH30030 FH30032 FH35012 FH35014 FH35016 FH35018 FH35020 FH35022 FH35024 FH35026 FH35028 FH35030 FH35032 FH30112 FH30114 FH30116 FH30118 FH30120 FH30122 FH30124 FH30126 FH30128 FH30130 FH30132 Figure 16: MetaFix Ludloff plate sterilizing case with implants, screws and instrument. Merete Technologies, Inc. (MTI) Page 17
- Ordering Information - Instrument Ref. Description FH10003 FH10004 FH11020 FH10045 FH10046 AC10020 CK10215 CK14207 CK00025 AI14225 AC14150 AC00007 FH10905 2.0 mm drill bit, L=15O mm, AO connector small 2.5 mm drill bit, L=15O mm, AO connector small 2.0 mm drill bit, cannulated 1.0 mm K-wire, L=120 mm, AO connector small 2.0 mm drill sleeve for locking screws 2.0 mm drill sleeve for locking screws Two way drill sleeve 1.0 mm K-wire / 2.0 mm drill 1.0 mm K-wire, L=15O mm, Trokar angle tip, round end 1.4 mm K-wire, L=70 mm, Trokar angle tip, round end Start Screw 2.5 mm hex screwdriver, cannulated 1.4 mm K-wire, L=15O mm Length gauge 0-90 mm for K-wire 1.4 mm L=15O mm Depth gauge 0-40 mm Bending wrench for Merete Foot system Merete Technologies, Inc. (MTI) Page 18
About the Company Merete GmbH is a medical technology company specializing in the manufacture of implants and instruments for endoprosthetics and osteosynthesis. With its name and qualified employees, Merete GmbH stands for many years of experience and innovative research and development, as well as for state-of-the-art manufacturing technology. Merete GmbH s activities are focused on the needs of patients, physicians and specialized personnel of clinics and out-patient surgical centers. A trained team of medical product consultants assists the clinics in the successful application of our products. Our extensive array of products ranges from tailor-made implants and instruments for orthopedic surgery and traumatology to sterile surgical disposables and post-surgical products, such as splints and bandages. We are always available to answer questions about our products and to respond to your individual wishes. The core competence of the company is the development and the production of implants and instruments for orthopedics and surgery, made of both metallic materials and modern synthetic materials. Due to our staff s specialized know-how in this field and our close collaboration with medical consultants and specialized medical product consultants, we can provide users with the necessary implants or biomaterials made either of metal, resorbable and non-resorbable plastic, as well as transplants of biological derivation. For further information for this or other products, please contact our customer service. HDB0026-0318 Distributed By: Merete Technologies, Inc. (MTI) One Lincoln Centre 18Wl4 0 Butterfield Road Oakbrook Terrace, IL 60181 Phone: 630-613-7182 Fax: 630-613-7184 www.mereteusa.com Produced By: Merete GmbH Alt-Lankwitz 102 12247 Berlin, Germany Phone: +49 (0) 30 77 99 80-0 Fax: +49 (0) 30 76 68 03 61 E-Mail: service@merete.de www.merete.de