Consensus Orthopedics Inc. Bespoke ACO Polyamide Acetabular Cup Orientation (ACO) guides and ACO bone models
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1 Consensus Orthopedics Inc. Bespoke ACO Polyamide Acetabular Cup Orientation (ACO) guides and ACO bone models IMPORTANT INFORMATION FOR SURGEON: PLEASE READ PRIOR TO USING THIS DEVICE IN A CLINICAL SETTING. THE SURGEON SHOULD BE FAMILIAR WITH THE SURGICAL TECHNIQUE. This document contains general instructions for use for polyamide Acetabular Cup Orientation guides and ACO bone models. For case-specific instructions please refer to the Case Report. DEVICE DESCRIPTION The Acetabular Cup Orientation System generates a pre-surgical plan based on CT imaging data using the Acetabular Cup Orientation Planner (software component). The software is then used pre-operatively by a qualified surgeon to inspect, fine-tune and approve the pre-surgical plan. Next, Acetabular Cup Orientation guides (ACO guides) are designed and manufactured based on the approved pre-operative plan. ACO guides (pic 1-3) are patient-specific templates that transfer the pre-operatively determined k-wire alignment pin location and the planned acetabular cup orientation to the patient intra-operatively. The surgical ACO guide is used to place a k-wire alignment pin under a pre- operatively planned orientation corresponding to the planned orientation of the cup implant to be placed during THA. This k-wire alignment pin serves as a visual reference during cup implant placement. The surgeon may then place the acetabular cup implant in the pre-operatively determined orientation by aligning the handle of a straight cup impactor with the k-wire alignment pin. This orients the cup inserter handle parallel to the k-wire alignment pin during insertion of the acetabular cup to achieve the preoperatively planned cup orientation. Refer to the surgical technique for all surgical steps and images of the ACO guides. Patient-specific templates (ACO guides) and ACO bone models are designed and manufactured in polyamide (plastic) using additive manufacturing (selective laser sintering), based on the approved pre-operative plan. ACO guides are used intra-operatively to transfer the alignment and orientation of the acetabular cup determined pre-operatively in the software. COMMON NAME Patient-specific instrumentation for hip arthroplasty (THA). CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician.
2 INDICATIONS The Acetabular Cup Orientation System is intended to be used as a surgical instrument to place a visual reference k- wire alignment pin to assist in the intra-operative orientation of acetabular cup components used with total hip arthroplasty procedures. The system utilizes anatomic landmarks of the pelvis that are clearly identifiable on pre- operative CT imaging scans. The Acetabular Cup Orientation System can be used with any 510(k) cleared, legally marketed, hemispherical acetabular cup implant system for primary THA and its respective compatible components, with the additional conditions listed below: A. Spherically shaped, symmetrical acetabular cups. B. Without protrusions for fixation such as spikes, threads, pegs, flanges or similar protruding elements. C. Cups with smooth outer surface or uniform coating. D. The central axis of the cup matches the direction of impaction; the inner and outer spherical surface of the cup have the same central axis. E. Cups have an apex hole to connect an impactor. F. Allowed deviations from a hemispherical cup shape (as long as the conditions stated above are fulfilled): o Cups with a very slightly flattened dome o Cups with one or more holes for fixation with screws. The ACO guides can only be used with hip systems that include reamers and impactors with straight handles. The ACO guides can be used for posterior approach (Moore, also referred to as the Southern approach ), postero-lateral approach (Marcy-Fletcher), lateral approach (Hardinge) and anterolateral approach (Watson-Jones). The ACO guides are intended for single use only. MATERIAL: Polyamide CONTRAINDICATIONS A. Acute/chronic local or systemic infection. B. Allergy to polyamide. C. Patients with morbid or extreme obesities making it impossible to free the acetabulum sufficiently for proper guide positioning and k-wire alignment pin placement. D. Patients with severe wear of the acetabular rim or other disorders that affect acetabular rim anatomy and bony landmark recognition.
3 E. Patients exhibiting severe wear of the acetabular rim region: the cases that fall into the next grades - Grade II from Crowe classification, Grade b from Hartofilakidis classification can be considered as severe wear. F. Revision surgery patients. G. ACO guides are not intended to be used with the anterior approach for THA. WARNINGS A. If the ACO guide is unable to be used for any reason, the surgeon should be prepared to use conventional instrumentation to perform the procedure. B. The user should be aware of possible allergic reactions to materials used in the ACO guide or ACO bone model. The patient should be informed on this matter by the user. C. The user should consult the instructions for use and surgical technique of the respective implant system and their compatible components for the indications, warnings, precautions, adverse effects and contra-indications. D. These are patient-specific, single use, disposable ACO guides and ACO bone models. E. Do not attempt to reuse or recondition the ACO guides or ACO bone models. F. Do not alter the ACO guides or ACO bone models from their original shape. Debris from the alteration could contaminate the operating region. In addition, altering the size of the guide may lead to an improper fit on the patient s anatomy. G. Do not use the ACO guide if full surface contact is not achieved between the guide and the underlying patient s anatomy. Pressure must be placed on the guide according to the push direction to maintain contact during use. Loss of contact between the ACO guide and the underlying anatomy may result in improper k-wire alignment pin orientation. H. Do not extract the place k-wire alignment pin and do not re-insert it in order to remove the ACO guide as it may result in improper k-wire alignment pin orientation I. Do not use surgical sawing instruments to cut the ACO guide cylinder arm because a correct pin orientation cannot be guaranteed after sawing. J. ACO guides are to be used by a trained orthopedic surgeon. K. The use of ACO guides can be difficult and not recommended while performing THA with posterior approach on patients with flexion contracture of the hip joint. L. Be aware that these patient-specific ACO guides and ACO bone models have been manufactured based on CT scans of the patient. If the patient s anatomy has changed significantly since the time of the CT scan, the ACO guides and ACO bone models should not be used. M. The ACO guides and ACO bone models should be properly cleaned before sterilization. Do not use if the ACO guides are broken, cracked, or are visibly contaminated. N. The ACO guides and ACO bone models in this package are provided non-sterile. The ACO guides and ACO bone models in this package must be sterilized prior to use. O. When using screws to fixate the cup in its position, the k-wire alignment pin needs to be removed prior to placement of the screws.
4 PRECAUTIONS A. It is advised to use the ACO guide or ACO bone model within 6 months after performing the CT scans on which they are based. If the patient s anatomy has changed significantly since the time of the CT-scan, the ACO guide or ACO bone model should not be used, even if the period of 6 months has not expired yet. B. Do not apply excessive force on the ACO guides or place heavy objects on top. C. Markings on ACO guides used for indicating anatomical references and case information must be legible. These include lines indicating anatomical directions, identifiers with case information such as the case identifier (see below). Notify your Materialise representative if the markings are not legible or if the identifiers do not correspond to the intended patient. D. In cases where the rim is broken outside the contact zones, the ACO guide can still be used after checking (by comparing with the ACO bone model) that all contact surfaces are intact. E. Performing the fit of the ACO guide on the ACO bone model before fitting it on the patient anatomy is mandatory for these cases. F. During reaming, ensure that the orientation of the placed k-wire alignment pin is not modified due to contact with the reamer. The ACO guides does not guarantee correct cup orientation when the orientation of the k-wire alignment pin is modified. G. After the ACO guide is removed from the acetabulum, perform surgical wound lavage or pulse lavage with a normal saline solution to clean any potential debris remaining after ACO guide usage. PATIENT-SPECIFIC ACO GUIDE IDENTIFIERS An identifier is indicated on each ACO guide and ACO bone model. This alphanumeric code links the guide unambiguously to the patient case. Each patient case is accompanied with a Content of the Box form and a Case Report, which specify all delivered surgical instruments, together with their identifier and a graphical illustration. Before using the ACO guide, check the identifier for readability and confirm that it corresponds with the Case ID on the Case Report. POSSIBLE ADVERSE EFFECTS Infection following the surgical procedure. Introduction of foreign materials can result in an inflammatory response or allergic reaction. INSTRUCTIONS FOR USE For case specific instructions consult the Case Report for the approved position and any additional comments regarding the use of the ACO guide before use intra-operatively.
5 Fitting the guide A. The ACO guide is designed to fit the patient anatomy. The fitting surface on the acetabular rim should be cleared of loose soft tissue to assure good fit of the ACO guide. This surface is indicated in the Planning Report delivered with the device. B. Do not remove osteophytes or alter the anatomy of the acetabular rim before fitting the ACO guide. C. Do not damage the bony surface where the ACO guide makes contact with the patient. D. If the acetabular rim is broken during the hip dislocation or other surgical manipulation, it is allowed to use the ACO guide ONLY if the broken zone is outside of the ACO guide contact (fit) surfaces. This can be verified with the ACO guide fit on the ACO bone model. E. Compare the fit position of the ACO guide to the planned fit position. The Case Report shipped with every ACO guide indicates the position of the ACO guide relative to the surrounding anatomy. The fitting position on the ACO bone model should match the fitting position on the patient s anatomy. F. Clasping the inferior arm of the ACO guide behind the posterior side of the acetabular notch by a rotational gesture confirms proper fit of the ACO guide G. If it is not possible to place the ACO guide on the patient in a stable position, the ACO guide does not guarantee an accurate transfer of the pre-operative planning. H. Even in a stable position, it is possible that the ACO guide does not make full contact with the bone over its entire surface, since it is not always possible to solve all of the undercuts. The undercuts depend on the shape of the patient s anatomy. During the design of the ACO guide the amount of undercut is kept to a minimum to ensure a maximal contact between the fitting surface and ACO guide. Inserting the k-wire alignment pin A. Verify that the correct k-wire alignment pin diameter is used which corresponds to the ACO guide s pin cylinder diameter. B. The ACO guide is to be used (unless explicitly requested otherwise in advance) with a metal k-wire alignment pin with a sharp edge of 2.0 mm diameter and mm length. C. Do not try to modify the drill direction by drilling through the drill cylinder s surface. D. Verify full surface contact is achieved between the ends of the 4 arms of the ACO guide and the underlying patient anatomy. E. Maintain pressure on the guide to keep contact between the guide surface and underlying patient anatomy during drilling. Removing the ACO guide A. Remove the ACO guide by sliding it off in the direction of the k-wire alignment pin. B. The placed k-wire alignment pin should not be altered in orientation and/or position by the ACO guide removal. C. If this is not possible to remove the ACO guide by sliding it off, one should make use of the recession in the cylinder arm of the ACO guide to snip it off by means of the surgical cutting pliers. The k-wire alignment pin in this case be safely used for further alignment.
6 D. Attention: The use of surgical sawing instruments should be avoided since a correct k- wire alignment pin position cannot be guaranteed after sawing off the ACO guide cylinder arm. E. Do not extract a placed k-wire alignment pin and re-insert it again in order to remove the ACO guide. F. After the ACO guide is removed from the acetabulum, perform surgical wound lavage or pulse lavage with a normal saline solution to clean any potential debris remaining after ACO guide usage. CLEANING AND STERILIZATION INSTRUCTIONS Acetabulum Cup Orientation System guides and ACO bone models are NOT STERILE and must be thoroughly cleaned and sterilized prior to use Manual cleaning of the ACO guide Rinse the ACO guides and ACO bone models under cold running tap water to remove visible soil. Use a soft bristled brush to remove visible soil from the surface of the ACO guides and ACO bone models. Use a syringe to flush cylinders and slots. Immerse the ACO guides and ACO bone models in a detergent and allow them to soak for a minimum of 25 minutes. The detergent should be of neutral or near neutral ph (ph 7-11 like ELMA TEC CLEAN N1). Use a soft bristled brush to remove visible soil from the surface of the ACO guides and ACO bone models. Use a syringe to flush cylinders and slots. Remove the ACO guides and ACO bone models from the detergent and rinse them in running RO/DI water. Dry the ACO guides and ACO bone models using a clean, soft lint-free cloth and filtered pressurized air. Automated Cleaning of the ACO guide Pre-rinse the ACO guides and ACO bone models under running tap water to remove visible soil. Use a soft bristled brush to remove visible soil from the surface of the ACO guides and ACO bone models. Use a syringe and long, narrow soft- bristled brush to flush cylinders and slots. Wash the ACO guides and ACO bone models using an automated washer unit. It is recommended to use a detergent as recommended by the manufacturer of the automated washer unit. Dry the ACO guides and ACO bone models with filtered pressurized air and/or wipe with a soft lint-free cloth.
7 Manual Pre-rinse Pre-Wash Wash Neutralize (if necessary) Rinse Thermal Disinfection Drying Minimum 1 minute Running tap water, clean with tools 2 minutes at 30 C-80 C Cold tap water 4 to 10 minutes at 60 C-80 C. The detergent should be of neutral or nearneutral ph (ph 7-11) Minimum 2 minutes Warm tap water with neutralizer Minimum 2 minutes at 40 C-80 C DI or PURW Minimum 7 minutes at minimum 94 C Dry with hot filtered air at minimum 90 C or wipe with soft lint-free cloth Sterilization of the ACO guide Recommended sterilization specifications The guides are intended for single use only. Users should conduct testing in the health care facility to ensure that conditions essential to sterilization can be achieved. The guides can be sterilized a second time in case the guides are dropped after the first sterilization. Please note that the guides should be cleaned per instructions above prior to each sterilization. Sterilize the ACO guides or ACO bone models using pre-vacuum steam sterilization before use. During sterilization of single devices, pouches may be used. Only legally marketed, FDA cleared and validated sterilization pouches should be used by the end-user for packaging the devices during sterilization. Use these standard steam sterilization settings 1,2 : Minimum temperature: 132 C (270 F) Minimum exposure time: 4 minutes Minimum vacuum drying time: 30 minutes CONTACT DETAILS For any questions or concerns, please contact your Consensus representative and/or Consensus customer service. Comments or changes regarding the use of this device can be directed to attention of the manufacturer: Materialise NV, Technologielaan 15, 3001 Leuven, Belgium. Consensus Orthopedics, Inc Windfield Way, Suite 100 El Dorado Hills, CA , U.S.A , info@consensusortho.com Part No Rev. A, Release Date: 4/2016, CRN Minimum validated steam sterilization temperature required to achieve a 10-6 sterility assurance level (SAL). 2. In the case that local or national specifications for steam sterilization requirements are stricter or more conservative than those listed in this table, please contact Consensus before sterilizing and using the guides.
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