Foot and Ankle Screw Instructions for Use

The implants in Forefoot Fixation System are individually packaged and provided sterile for single use only.

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Foot Plating System (FPS)

Signature Orthopaedics' Foot Plating System (FPS) is designed for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet. Signature Orthopaedics' FPS is manufactured from implant grade Ti6Al4V. Signature Orthopaedics' FPS is available in a range of sizes and shapes to compensate for the anatomical variation of different patients group.

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Foot and Ankle Screw and Plating Range Subtalar Implant, Forefoot Fixation Implant, Foot Plating System Instructions for Use 191-07-0901 Rev. G

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Issue Date:10/2020

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General Instructions

The Signature Orthopaedics' range of foot and ankle screw and plating systems are intended for use in the correction of pathological conditions and deformities of the foot and ankle. Prior to undertaking the procedure, patients must be evaluated according to the indications and contraindications of the particular system, as well as the patient selection criteria included in this document. Patients must also be informed of the precautions and possible adverse effects of the procedure, and of appropriate postoperative recovery procedures. The surgeon must be thoroughly knowledgeable not only in the medical and surgical aspects of the implants, but must also be aware of their mechanical limitations. The device is intended to restrict the unwanted movement of bones within the foot/ankle joint, to help correct alignment. The device is not intended to support in-vivo loading indefinitely. Signature Orthopaedics implants and instruments should only be used with approved devices and accessories.

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 Patients with active, systemic infection.  Patients with Sepsis  Patients with Osteoporosis bone  Patient conditions including blood supply limitations, and insufficient quantity or quality of bone or soft tissue.  Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.  Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation of the device.

Forefoot Fixation System

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SEC Screw is available in long and short thread options and various length. It has self tapping feature, differential pitch and provides primary fixation and compression of metatarsal osteotomies Twist-off offers two options (Pin Loaded and Chuck Loaded) and various length for convenience of patients of different age and bone quality. Staple offers the options of Straight (90°) or oblique (26°) and various length. staples are used for simple and strong fixation of Akin osteotomies.

Contraindications

 Patients with superstructural alignment deformities.

The R2 subtalar implant is a conical, threaded implant inserted into the sinus tarsi. It is intended to block the forward, downward, and medial displacement of the talus, thus allowing normal subtalar joint motion but limiting excessive pronation. The R2 implant is manufactured from implant grade Ti6Al4V titanium alloy and available in 6 sizes from 712mm in diameter. The implant has self-locking wedge design, with a cannulated centre and a hexagonal drive feature at the head for insertion. The implant is provided individually packaged sterile for single use only.

Signature Orthopaedics' Forefoot Fixation System (FFS) is designed to be placed into the Metatarsals and Forefoot for small bone fixation. The devices in FFS are manufactured from implant grade Ti6Al4V. The FFS consists of SEC Screw, Twist-off and Staple that are described below:

Metatarsal fracture Lisfranc dislocation/fracture Cuboid fracture Navicular fracture Metatarsal osteotomies Calcaneal valgus deformity Lapidus MTP fusion TMT fusion Lateral column lengthening Medial column reconstruction Calcaneal fracture Naviculocuneiform fusion Talonaviculocuneiform fusion Talonavicular fusion Calcaneocuboid fusion Weil osteotomy Plantarflexed talus Severe pronation Congenital and painful flatfoot deformity Failed correction with long-term orthotic treatment Repair of tarsal coalitions Posterior tibial tendon dysfunction Paralytic flat foot deformity Subtalar instability

Components of the Signature Orthopaedics range of foot and ankle screw and plating systems are contraindicated for:

Subtalar Implant

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4)

Instruments supplied with Signature Orthopaedics' Foot and Ankle Screw and Plating Systems are supplied non-sterile and are intended to be cleaned and sterilized prior to use in accordance with the procedure outlined in section 13 of this document. The instruments are intended to be used multiple times but they must be cleaned and sterilized between use.

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Adequately instruct the patient. Postoperative care is important. The patient’s ability and willingness to follow instructions is one of the most important aspects of successful internal stabilization. Patients affected with senility, mental illness, alcoholism, and drug abuse may be at a higher risk of device or procedure failure. These patients may ignore instructions and activity restrictions. The patient is to be made aware and warned of general surgical risks, possible adverse effects, and to follow the instructions of the treating physician. The patient is to be advised of the need for regular postoperative follow-up examinations as long as the device remains implanted.

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Correct handling of implants is extremely important. Do not modify implants. Do not notch implants. Notches or scratches put in the implant during the course of surgery may contribute to breakage.

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Prior to use, inspect the device to ensure it is not damaged. Do not use a device that is scratched, bent or damaged in any way.

8)

Correct selection of the implant is extremely important. The potential for success in internal stabilization procedures is increased by the selection of the proper type of implant. An undersized implant may not seat firmly within the cavity and increase the risk of loosening. An oversized implant may fracture or excessively stress surrounding bone. The devices are designed to carry loading through the joint whilst correction occurs, however it is unreasonable to assume that any implant can withstand unsupported in-vivo loading indefinitely.

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Prosthetic components from different manufacturers must not be combined. All devices should only be used according to the package directions in conjunction with the specified surgical technique and instructions for use. Additional warnings and precautions may be included in component literature.

Components of the Signature Orthopaedics’ range of foot and ankle screw and plating systems are intended to correct deformities and pathological conditions of the foot and ankle. The indication for use of Signature Orthopaedics' Foot and Ankle Screws and Platings includes the following:

Caution: Carefully read all the instructions and be familiar with the surgical technique(s) prior to use of the system. This product must only be used by trained, qualified persons, aware of the directions for use. U.S. Federal law restricts this device to sale, distribution and use by or on the order of a physcian.

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Indications

use, and must be disposed following explantation. Reusing implanted components increases the likelihood of fatigue failure and may lead to cross-contamination between patients, and is strictly prohibited.

 Any condition not described in the indications for use

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Warnings and Precautions

1)

U.S Federal law restricts this device to sale by or on the order of a physician.

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It is the surgeon’s responsibility to be familiar with the appropriate surgical techniques prior to use of this device. These instructions must be read in their entirety before use of the device.

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Signature Orthopaedics' Foot and Ankle Screw and Plating Systems are supplied sterile. Resterilisation of these devices may alter devices' material properties including mechanical properties and/or biocompatibility, therefore resterilisation of these devices is strictly prohibited. Implanted components are intended for single

10) Careful attention should be paid to asepsis and avoidance of anatomical hazards. Thorough debridement during the procedure is recommended to reduce the likelihood of infection. 11) Inadequate fixation at the time of surgery can increase the risk of loosening and migration of the device. Sufficient bone quantity and quality are important to adequate fixation and success of the procedure. Bone quality must be assessed at the time of surgery. Adequate fixation in diseased bone may be more difficult. Patients with poor quality bone, such as osteoporotic bone, are at greater risk of device loosening and procedure failure. 12) The use of appropriate immobilization and postoperative management is indicated as part of the treatment until healing has occurred. 13) Signature Orthopaedics’ does not recommend MR imaging for any patients implanted with the foot and ankle screws and platings systems' components without prior consultation with an expert radiologist for assessment of potential adverse events such as device movement, localized burns, torsional or shear strain on the implanted device.

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Possible Adverse Events

The Signature Orthopaedics' range of foot and ankle screw and plating systems have the following possible adverse events:  Fracture of the implants due to the excess loading  Incomplete or inadequate healing  Nerve damage resulting from surgical trauma  Delayed correction in alignment  Pain, discomfort or abnormal sensations due to presence of implant  Decrease in bone density due to stress shielding  Migration or loosening of the implant  Foreign body reaction  Infection  Allergic reaction