Search Results

The Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors are indicated to be used for suture or tissue fixation in the elbow, shoulder, hand, wrist, foot, ankle, knee, and hip. Specific indications are listed below: Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Hand Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty) Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hip: Capsular repair, acetabular labral repair.

The Suture Anchors, manufactured by GM dos Reis Indústria e Comércio Ltda, are anchor-type implants, and are composed of two groups of anchors, manufactured in Titanium Alloy (ASTM F136) and Ultra High Molecular Weight Polyethylene – UHMWPE (which are called ZIP Anchor), that is the same raw material of the suture. The anchors are made available preloaded in a disposable inserter device, composed of a metal rod and a polymeric cable. The implant and disposable inserter devices are unique products and cannot be sold separately. Implants of the Suture Anchors - GM Reis are classified as surgically invasive, non-absorbable, and non-active implantable medical devices. In addition, the implants, as well as, the inserter device, are for single-use and sold in sterile form - supplied as a sterile kit for ethylene oxide (ETO) according to ISO 11135 - "Preview Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices". The Suture Anchors - GM Reis is composed of two different groups of anchors: - HTA – Headless Titanium Anchor. - Anchor Diameters: ø1,7 mm; ø2,2 mm; ø2,7 mm; ø3,5 mm and ø5,0 mm - -ZIP Anchor. - Ø0.9mm; Ø1.2mm; Ø1.5mm; Ø1.8mm; Ø1.9mm; Ø2.6mm.

Mini and Micro Fragments Reconstruction System - GMReis is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and wrist. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.

Mini and Micro Fragments Reconstruction System – GMReis is composed of plates and screws. The bone plates are made from commercially pure titanium alloy (Ti-4Al-6V) and the bone screws are manufactured from titanium alloy only. The plates range in thickness from 0.6 to 2.0 mm, and the screws range in diameter from 1.5 to 2.7 mm. They are available on different sizes and shapes, according the implantation site and the extension of the fracture. Mini and Micro Fragments Reconstruction System – GMReis are for single use. The devices are provided non-sterile and must being properly cleaned and sterilized before use, according the recommendations provided in the Instructions for Use. In order to promote a correct placement of the plates and screws, GMReis has also available a range of instruments (class I exempt) to serve the surgeon such as drills, drill guides, cutting pliers, reamers, screwdrivers, among others. GMReis recommends the use of these instruments in order to ensure the compatibility with the implants and promote the success of the procedure. The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in osteosyntheses procedures.

The Pedimax II - Pedicle Screw Spinal System is indicated for posterior, non-cervical fixation in skeletally mature patients. It is intended to be used as an adjunct to fusion using autograft. The device is indicated for the treatment of the following acute and chronic instabilities or deformittes: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Not Found