Standards Development

Scope

This Document establishes the requirements for the design, material, manufacturing, packaging, labeling and performance of bone anchoring system of the type suture anchors. This Document applies to suture anchors designed to be attached to the bone tissue by threading, by expansion or by impact.

This Document does not apply to knot fixations used as bone anchoring systems, which consists exclusively of wire or tape.

Purpose

Suture anchors are orthopedic implants intended for anchoring flexible strands or yarns (commonly known as ‘sutures’) intended to provide the attachment of soft tissues (for example, ligament and tendon) to the bone in various anatomical locations.

Clinically, suturing is the act or effect of joining the edges of a cut, a wound, an incision, with a special needle and yarn, to promote healing. Although the transfixation of a yarn or tape to the soft tissue for bone anchorage is not necessarily considered a suture, historically this term has been used to designate this means of fixing soft tissues to the bone.

It should be noted that there are other soft tissue anchorage systems. In this spectrum, there are those in which the flexible strands or yarns are used, during the surgical procedure, only as an instrument for approximating the soft tissue in the desired position, as well as those consisting exclusively of flexible strands or yarns (system self-anchoring). In these two cases, bone anchorage systems provide anchorage between bone tissue and soft tissue, such as that promoted in the case of interference screws, characterized as soft tissue anchors, as opposed to the term suture anchors. It is important to note that, in these screws, the term interference is associated with the way of fixing the soft tissue, and not the anchor, in the bone tissue. In suture anchors, the flexible tape or yarn anchored to the bone structure constitutes the structural anchoring element of the soft tissue.

This element can be supplied either as a component of the bone anchoring system or to be selected by the user.

Suture anchors present designs suitable for use in different anatomical sites, such as hand, wrist, elbow, shoulder, hip, knee, foot and ankle, and are introduced into the bone structure of the anatomical site to which they are intended by the use of an applicator into the host bone, with or without a guide hole previously prepared for this purpose.

Although no material for surgical implantation is shown to be completely free of adverse reactions in the human body, the materials indicated in this Document have been used successfully for more than a decade in the manufacture of suture anchors for surgical use in humans in applications where it occurs contact of the implant with bones and soft tissues, and prolonged clinical experience of using this material show that an acceptable level of biological response can be expected when the material is used in appropriate applications.