Search Results

The Smith & Nephew BIORAPTOR◊ Suture Anchor is indicated for the reattachment of soft tissue to bone for the following indications: **Hip:** - Hip Capsule Repair - Acetabular labrum reattachment/reconstruction **Shoulder:** - Capsular stabilization - Bankart repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions - Acromioclavicular separation repairs - Deltoid repairs - Rotator cuff tear repairs - Biceps tenodesis **Foot and Ankle:** - Hallux valgus repairs - Medial or lateral instability repairs/reconstructions - Achilles tendon repairs/reconstructions - Midfoot reconstructions - Metatarsal ligament/tendon repairs/reconstructions - Bunionectomy **Elbow, Wrist, and Hand:** - Biceps tendon reattachment - Ulnar or radial collateral ligament reconstructions - Lateral epicondylitis repair **Knee:** - Extra-capsular repairs: - Medial collateral ligament - Lateral collateral ligament - Posterior oblique ligament - Patellar realignment and tendon repairs - Vastus medialis obliquous advancement - Iliotibial band tenodesis Smith & Nephew BIORAPTOR◊ Curved 2.3 PK Suture Anchors are indicated for the reattachment of soft tissue to bone for the following indications: **Shoulder:** - Capsular stabilization - Bankart repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions - Acromioclavicular separation repairs - Deltoid repairs - Rotator cuff tear repairs - Biceps tenodesis **Foot and Ankle:** - Hallux valgus repairs - Medial or lateral instability repairs/reconstructions - Achilles tendon repairs/reconstructions - Midfoot reconstructions - Metatarsal ligament/tendon repairs/reconstructions - Bunionectomy **Elbow, Wrist, and Hand:** - Biceps tendon reattachment - Ulnar or radial collateral ligament reconstructions - Lateral epicondylitis repair **Knee:** - Extra-capsular repairs: - Medial collateral ligament - Lateral collateral ligament - Posterior oblique ligament - Patellar realignment and tendon repairs - Vastus medialis obliquous advancement - Iliotibial band tenodesis The Smith & Nephew BIORAPTOR◊ Suture Anchor is intended for the reattachment of soft tissue to bone. The Smith & Nephew BIORAPTOR◊ Curved 2.3 PK Suture Anchor is intended for the reattachment of soft tissue to bone.

The Smith & Nephew BIORAPTOR 2.3 PK and BIORAPTOR Curved 2.3 PK Suture Anchors are fixation devices intended to provide secure attachment of soft tissue to bone. The devices consist of a suture anchor with attached non-absorbable suture(s) preassembled to an insertion device. The BIORAPTOR Curved 2.3 PK Suture Anchors are preassembled to a flexible insertion device.

The subject device can be used with the TRIGEN META-TAN Trochanteric Antegrade Nailing System, TRIGEN TAN FAN Trochanteric Antegrade and Femoral Antegrade Nailing System, and the TRIGEN META-NAIL Retrograde Femoral Nail System therefore the indications for use for all three systems are applicable to the subject TRIGEN Stable Lock Nut & Washer. ### TRIGEN META-TAN Trochanteric Antegrade Nailing System The TRIGEN META-TAN Trochanteric Antegrade Nail is indicated for fixation of fractures that occur in and between the proximal third and distal fourth of the femur including simple long bone fractures, severely comminuted, spiral, and segmental fractures, and supracondylar fractures. In addition, TRIGEN META-TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; intertrochanteric fractures; and intracapsular fractures. ### TRIGEN TAN FAN Trochanteric Antegrade and Femoral Antegrade Nailing System Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted spiral, large oblique and segmental fractures; and nonunions. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (e.g. Femoral Antegrade Nail, Trochanteric Antegrade Nail and Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures and intertrochanteric fractures. ### TRIGEN META-NAIL Retrograde Femoral Nail System The TRIGEN META-NAIL Retrograde Femoral Nail is indicated for fractures of the femur including stable and unstable distal metaphyseal fractures, diaphyseal fractures, intra-articular fractures, and peri-prosthetic fractures.

The device in scope of this submission is the TRIGEN Stable Lock Nut & Washer. The TRIGEN Stable Lock Nut & Washer is intended to be used as an aid to normal fracture healing for fractures that occur in and between the proximal third and distal fourth of the femur including simple long bone fractures, severely comminuted, spiral, and segmental fractures, and supracondylar fractures; simple long bone fractures; severely comminuted spiral, large oblique and segmental fractures; nonunions; for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated; and for fractures of the femur that include stable and unstable distal metaphyseal fractures, diaphyseal fractures, intra-articular fractures, and peri-prosthetic fractures. The TRIGEN Stable Lock Nut & Washer is made from Ti-6Al-4V material. The device is Gamma sterilized and intended for single-use only.

- Rheumatoid arthritis; - Post-traumatic arthritis, osteoarthritis, or degenerative arthritis; - Posterior stabilized and constrained knee systems are also indicated for the treatment of unicompartmental replacement or total knee replacement; - Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. - Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent.

The subject insert is a line addition to the LEGION Inserts with JOURNEY Lock (K200407) and has undergone design modifications to provide a new articulating surface that incorporates a flatter lateral plateau and extended medial geometry to match the asymmetry of the tibial baseplate, while maintaining the JOURNEY locking mechanism. The subject LEGION Medial Stabilized Inserts with JOURNEY Lock have a size range of 1-2, 3-4, 5-6, and 7-8mm with thicknesses of 9, 10, 11, 12, 13, 15, 18mm, and come in both left (LT) and right (RT) configurations. The LEGION Medial Stabilized XLPE Inserts with JOURNEY Lock are provided sterile via Ethylene Oxide sterilization and are intended for single use only. The subject inserts are intended to be used with compatible knee systems for total knee arthroplasty in skeletally mature patients with or without bone cement.

The CATALYSTEM Femoral Stems are intended for total and partial hip arthroplasty in skeletally mature patients for the following indications: Hip components are indicated for individuals undergoing primary surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, congenital dysplasia, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip. The CATALYSTEM Femoral Stems are intended for use without bone cement.

The purpose of this Special 510(k) is to notify the FDA of Smith & Nephew's intent to market the CATALYSTEM Femoral Stems with additional femoral head compatibility. The CATALYSTEM Femoral Stems were previously cleared by the FDA under K240381. The CATALYSTEM Femoral Stems consists of femoral stem implants intended for primary in skeletally mature patients. The CATALYSTEM Femoral Stems are provided sterile to the user via gamma irradiation. The subject CATALYSTEM Femoral Stems are comprised of two variants: CATALYSTEM Collared and CATALYSTEM Collarless. Both variants are available in standard and high neck offset options. The CATALYSTEM Femoral Stems are intended to be used with Smith & Nephew femoral heads and acetabular components for total hip arthroplasty and hip hemiarthroplasty.

The EVOS Pelvic and Acetabular System is indicated for fixation of fractures and/or disruptions of the pelvis and acetabulum in skeletally mature patients.

The subject EVOS Pelvic and Acetabular System consists of Class II bone plate and screw implants. The subject bone plates are available in a variety of shapes and sizes. The subject screws consist of locking screws as well as cannulated screws. The subject plates are also compatible with the previously cleared EVOS locking screws, and partially and fully threaded osteopenia screws (K140814 S.E. 5/7/2014 and K162078 S.E. 7/27/2016). The proposed plates and screws are manufactured from implant-grade 316L Stainless Steel material and will be available in a sterile packaged condition.

The RENASYS Foam and Gauze Wound Dressing Kits with AIRLOCK Technology and Soft Port are intended to be used in conjunction with Smith + Nephew traditional Negative Pressure Wound Therapy (tNPWT) RENASYS system. The Smith + Nephew RENASYS NPWT system is indicated for patients who would benefit from a suction pump (Negative Pressure Wound Therapy), as it allows for wound management via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Appropriate wound types include: - Chronic - Acute - Traumatic - Sub-Acute and dehisced wounds - Ulcers (such as pressure or diabetic) - Partial-thickness burns - Flaps - Grafts

RENASYS Foam and Gauze Wound Dressing Kits with AIRLOCK Technology and Soft Port are accessories intended for use in conjunction with RENASYS TOUCH, RENASYS GO and RENASYS EDGE Negative Pressure Wound Therapy systems.

BIOBRANE Dressings are indicated for: - Covering clean partial thickness burn wounds - Split thickness donor sites BIOBRANE Glove is indicated for: - Covering clean partial thickness burn wounds of the hand.

BIOBRANE Dressing and BIOBRANE Glove are wound dressings made from an ultrathin, semipermeable, perforated silicone membrane that is mechanically bonded to a flexible knitted tri-filament nylon fabric. Denatured porcine dermal collagen is bonded to the silicone-nylon membrane to provide a flexible and conformable dressing with adherence properties and a hydrophilic surface.

The TRIGEN META-TAN Trochanteric Antegrade Nail is indicated for fixation of fractures that occur in and between the proximal third and distal fourth of the femur including simple long bone fractures, severely comminuted, spiral, and segmental fractures, and supracondylar fractures. In addition, TRIGEN META-TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; intertrochanteric fractures; and intracapsular fractures.

The device in scope of this submission is the TRIGEN META-TAN Trochanteric Antegrade Nail. TRIGEN META-TAN Trochanteric Antegrade Nails are intended to be used as aids to normal fracture healing of the femur. They are made from Ti-6Al-4V material and available in a nail size range of 30 to 50 cm in 2 cm increments. They are Gamma sterlized and intended for single-use only.

The REGENETEN™ Bioinductive* Implant is indicated for the management and protection of tendon or extra-articular ligament injuries in which there has been no substantial loss of tendon or ligament tissue. * Bioinductivity has been demonstrated for tendon only. The REGENETEN Bioinductive Implant Delivery System is indicated for the arthroscopic delivery of the REGENETEN Bioinductive Implant.

The REGENETEN™ Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons or ligaments. The implant is designed to provide a layer of collagen between a tendon or ligament and the surrounding tissue. After hydration, the implant is an easy-tohandle, pliable, nonfriable, porous collagen sheet. The REGENETEN Bioinductive Implant is provided sterile, non-pyrogenic, for single-use only, in a variety of sizes, in a dual sterile seal.

In Anatomic: The AETOS Shoulder System (when used with the AETOS Humeral Meta Stems) is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The AETOS humeral stems (AETOS Humeral Meta Stems) and head may be used by themselves, as a hemiarthroplasty, if the natural dlenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. When used with the AETOS Humeral Meta Stems, The AETOS Shoulder System is indicated for use as a replacement of shoulder joints disabled by: - Rheumatoid arthritis - · Non-inflammatory degenerative ioint disease - · Correction of functional deformity - · Fractures of the humeral head - · Traumatic arthritis - Revision of other devices if sufficient bone stock remains The AETOS Shoulder System (when used with AETOS Stemless Humeral Prosthesis) is to be used only in patients with an intact or reconstructable rotator cuff. When used with AETOS Stemless Humeral Prosthesis, the AETOS Shoulder System is indicated for anatomic total shoulder replacement of shoulder joints disabled by: - · Non-inflammatory degenerative joint disease - · Traumatic arthritis - Revision of other devices if sufficient bone stock remains The coated humeral components are intended for uncemented use. The glenoid component is intended for cemented use only. In Reverse: The AETOS Shoulder System, when used with AETOS Humeral Meta Stems, is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by: - Rheumatoid arthritis - · Non-inflammatory degenerative joint disease - · Correction of functional deformity - Fractures of the humeral head - Traumatic arthritis - · Revision of devices if sufficient bone stock remains The humeral liner component is indicated for use in the AETOS Shoulder System as a primary reverse total shoulder replacement and for use when converting an anatomic AETOS Shoulder System into a reverse shoulder construct. This facilitates the conversion without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The component is permitted to be used in the conversion from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthroplasty is associated with a massive and non-repairable rotator cuff tear. The coated humeral stems are indicated for uncemented use. The coated glenoid base plate is intended for cementless application with the addition of screws for fixation. Note: All implant components are single use.

The AETOS Stemless Humeral Prosthesis subject to this submission is a humeral anchor intended for press-fit fixation as part of an implant construct in anatomic total shoulder arthroplasty for the treatment of skeletally mature individuals with degenerative diseases of the glenohumeral joint.