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The Disposable Endoscopic Cutter Stapler and Cartridge has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and creation of anastomosis. The Disposable Endoscopic Cutter Stapler and Cartridge is not to be used in the transection and resection of solid organs.

Disposable Endoscopic Cutter Stapler and Cartridge place two, triple-staggered rows of progressive titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths with cartridge in 2.0/2.5/3.0, 3.0/3.5/4.0, 4.0/4.5/5.0 three progressive staple sizes to accommodate carious tissue thickness. The device may be reloaded and fired up to 12 times in a single procedure.

Simple, compound first- and second-degree tibial shaft fractures Pseudarthrosis and delayed union

The WASTON Metallic Intramedullary Nail System is a temporary fixation intramedullary nail designed for fracture fixation and stabilization of the tibia. The system consists of intramedullary nail, locking screw, end cap and instruments. The intramedullary nail is available in a variety of lengths to meet assorted anatomical needs. Each of the nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections. All implants of Metallic Intramedullary Nail System are manufactured from Ti-6Al-4V alloy that meets the requirements of ASTM F-136. The proposed devices are provided un-sterilized, but shall be sterilized via autoclave method to achieve Sterility Assurance Level of 10-6 by hospital prior to use.

The WASTON General Spinal System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion, (5) spinal stenosis. It is not intended for pedicle screw fixation above T8.

The WASTON General Spinal System consists of Fixed-Angle Screws, Fixed-Angle Reduction Screws, Rods, Crosslink and Set Screws. The proposed general spinal system is made of Titanium Alloy (Ti6Al4VELI), which meets ASTM F136-02a, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10th by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

WASTON Metallic Bone Plate and Screw Systems are intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, nonunions and malunions, and osteotomies of the femuri

The proposed products, WASTON Metallic Bone Plate and Screw Systems, contain (1) Distal lateral femoral (condylar) LOC plate, (2) Bone screws and (3) various specific instruments. The raw material of the plate, titanium, conforms to ASTM F67-13, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50400, UNSR50550, UNS R50700). The bone screws are made of titanium alloy (TI-6AL-4V ELI), which complies with ASTM F136-13, Standard Specification for Wrought Titanium-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The devices are provided un-sterilized, but shall be sterilized via autoclave method to achieve Sterility Assurance Level of 10-6 by hospital prior to use.

The Duocentric® Reversed shoulder prosthesis is indicated for use in case of gross rotator cuff deficiency including when it is associated with osteoarthritis, revision of previous arthroplasty or complex fracture of the humerus (3 fragments or more) in an older population (e.g. 65 years of age or older). The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The humeral stem is intended for use with cement when polished or without cement when coated with Hydroxyapatite. All other components are intended for cementless use only. The glenoid baseplate is intended for cementless application with the addition of three screws for fixation. It is coated with a double layer of pure Titanium and Hydroxyapatite on its posterior side. The additional component bail out head is intended when, during primary surgery for the Duocentric® Reversed shoulder prosthesis 1) the glenoid bone stock appears to be insufficient to bear the implant of the glenoid components, or 2) the glenoid bone fractures intra-operatively.

The Duocentric® Reversed shoulder prosthesis is a prosthesis that uses the biomechanical concepts of reverse shoulder arthroplasty as originally described by Paul Grammont. The Duocentric® Reversed shoulder prosthesis is composed of a humeral stem, a humeral baseplate, a humeral insert, a gleonosphere (Duoglene), and a glenoid baseplate already cleared under K103251. It also includes a "bail out head" for use during rare occasions during surgery to salvage the procedure. The humeral insert is made of ultra-high-molecular-weight polyethylene (UHMWPE), while all other components are made of wrought high nitrogen stainless steel M30NW. The humeral stem is intended for cemented use unless coated with hydroxyapatite (HA). The glenoid baseplate is coated with a double coating of pure titanium and hydroxyapatite (Ti/HA), is intended for cementless use, and is fixated with wrought high nitrogen stainless steel screws. The device is provided sterile. The HA and Ti/HA coatings conform to ASTM standards ASTM F1185, ASTM F1609, and ASTM F1580 and are performed by Medical Coating'(Vault-en-Velin, FR) according to their Master File MAF-1633. This submission includes an additional component, a bail out head. This additional component is included to provide a solution to the surgeon 1) when during the primary surgery, the glenoid bone stock appears to be insufficient to bear the implant of the glenoid components or 2) glenoid bone fracture occurs intra-operatively.

The TREGOR® Dual Mobility Acetabular System is indicated for hip pathologies requiring total hip replacement (THR): - Non inflammatory or rheumatoid arthritis; - Osteonecrosis of femoral head; - Hip deformity affecting its function; - Non-union head fracture or complex pertrochanteric fracture that are unmanageable using other techniques; - Revision of previous hip surgery; - Dislocation risks (e.g., ASA score ≥ 3) The TREGOR® Dual Mobility Acetabular System hip prosthesis is intended for use in skeletally mature individuals undergoing surgery for rehabilitating hip joints.

The TREGOR® Dual Mobility Acetabular System includes the acetabular components of a total hip prosthesis. Its design is based on the original 1976 Dual Mobility design developed by Prof. Bousquet: it uses two distinct articulating surfaces. The TREGOR® Dual Mobility Acetabular System is composed of a metal acetabular cup/shell and a dual mobility polyethylene insert. The articulating surfaces are: between the cup and the dual mobility insert, and between the dual mobility insert and the femoral head. The acetabular cup is made of wrought high nitrogen stainless steel (M30NW) for the cemented cup design (TREGOR® Medial Cup) and of Cobalt/Chromium alloy for all other cementless cup designs that are intended for a press-fit application. When used with cement, an acetabular reinforcement accessory with screws may also be used. When used without cement, the cup may include additional fixation aids (screws, pegs, blades) and includes a non-porous double coating. The plasma spray coating is made of pure titanium and hydroxyapatite (Ti/HA). The insert is made of ultra-high-molecular-weight polyethylene (UHMWPE). There are five configurations of acetabular cups covering a wide range of sizes with dual mobility inserts compatible with 28 mm prosthetic femoral heads made of CrCo or ceramic: - TREGOR® Standard (6 sizes from 52 to 62 mm outer diameter): Ti/HA coating, cementless and press fit application. - TREGOR® 3 Blades (6 sizes from 52 to 62 mm outer diameter): Ti/HA coating, cementless and press fit application. Blades provide additional fixation. - TREGOR® + (7 sizes from 52 to 64 mm outer diameter): Ti/HA coating, cementless and press fit application. Blades and screws provide additional fixation. - TREGOR® Tripod (7 sizes from 52 to 64 mm outer diameter): Ti/HA coating, cementless and press fit application. Pegs and screw provide additional fixation. - TREGOR® Medial Cup (5 sizes from 52 to 60 mm outer diameter): for cemented use only. An optional acetabular reinforcement cross is for cemented use only. The device is single use and provided sterile. This premarket notification does not include the femoral components. The TREGOR® Dual Mobility Acetabular System is compatible with FDA cleared StelKast femoral components: Provident, Protract and Progeny femoral stems with the femoral heads made of cobalt-chromium and ceramics, listed below. The femoral heads fully cover the morse taper of the femoral stem neck and the stems all have a polished, highly polished or electro-polished neck: - Prosthetic head made of Cobalt-Chromium: 28 mm (StelKast reference SC1151: -5 mm, -3.5 mm, standard and +3.5 mm offset) - Biolox Delta Femoral head: 28 mm (StelKast reference SC3347, -3.5 mm, standard and +3.5 mm offset)

Implantation of a joint prosthesis is to be considered only when all other surgical options have been carefully examined and found less appropriate. The Duocentric® Reversed shoulder prosthesis is indicated for use in case of gross rotator cuff deficiency including when it is associated with osteoarthritis, revision of previous arthroplasty or complex fracture of the humerus (3 fragments or more) in an older population (e.g. 65 years of age or older). The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The humeral stem is intended for use with cement when polished or without cement when coated with Hydroxyapatite. All other components are intended for cementless use only. The glenoid baseplate is intended for cementless application with the addition of three screws for fixation. It is coated with a double layer of pure Titanium and Hydroxyapatite on its posterior side.

The Duocentric® Reversed shoulder prosthesis is a prosthesis that uses the biomechanical concepts of reverse shoulder arthroplasty as originally described by Paul Grammont. The Duocentric® Reversed shoulder prosthesis is composed of a humeral stem, a humeral baseplate, a humeral insert, a gleonosphere (Duoglene), and a glenoid baseplate. The humeral insert is made of ultra-high-molecular-weight polyethylene (UHMWPE), while all other components are made of wrought high nitrogen stainless steel M30NW. The humeral stem is intended for cemented use unless coated with hydroxyapatite (HA). The glenoid baseplate is coated with a double coating of pure titanium and hydroxyapatite (Ti/HA), is intended for cementless use, and is fixated with wrought high nitrogen stainless steel screws. The device is provided sterile. The HA and Ti/HA coatings conform to ASTM standards ASTM F1185, ASTM F1609, and ASTM F1580 and are performed by Medical Coating (Vault-en-Velin, FR) according to their Master File MAF-1633.

The Disposable Circular Stapler is intended to be used throughout the alimentary tract for the creation of end-to-end and end-to-side anastomosis.

The Disposable Circular Stapler places a circular, double staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis. The instrument is activated by squeezing the handle firmly as far as it will go. It is applicable to end-to-end and end-to-side anastomosis. The proposed device is provided EO sterilized.