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The KeYi Total Knee System indications for use are: · Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis) or rheumatoid arthritis. - · Correction of functional deformities. - · Post-traumatic loss of knee joint configuration and function. - · Moderate valgus, varus, or flexion deformity. - · Knee fractures untreatable by other methods. The KeYi Total Knee System is indicated for cemented use only.

The KeYi Total Knee System is a fixed-bearing, posterior stabilized (PS) arthroplasty device. It is a patellofemorotibial, polymer, semi-constrained, cemented knee prosthesis that consists of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy femoral component, ultra-highmolecular-weight polyethylene (UHMWPE) tibial insert, titanium (Ti) alloy tibial baseplate and UHMWPE patellar component. The device has tibial inserts with posts and femoral components with cams that interact with the posts to help stabilize the knee after the posterior cruciate ligament is removed. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component.

The KeYi Total Hip System is designed for total hip arthroplasty. The indications for use are: a. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. b. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. c. Proximal femoral fractures. d. Avascular necrosis of the femoral head. e. Non-union of proximal femoral neck fractures. f. Other indications such as congenital dysplasia, arthrodesis conversion, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteoporosis, pseudarthrosis conversion, and structural abnormalities. The Ke Yi femoral stems are indicated for cementless use. The KeYi acetabular shells are indicated for cemented or cementless use.

The KeYi Total Hip System is a porous-coated, semi-constrained, hip prosthesis designed for either primary or revision hip arthroplasty. The system is comprised of femoral stems and mating metal femoral heads; acetabular shells and mating acetabular liners; optional acetabular cancellous bone screws; and optional acetabular dome hole plug. The KeYi Femoral Stems are forged titanium alloy, feature a proximal CP Titanium plasma porous coating, and are offered in a range of sizes. The KeYi Femoral Heads are polished cobalt chromium alloy and designed to mate with 12/14 taper of the femoral stem through taperlocking arrangement and to articulate with the acetabular liner. The heads are available in different sizes with various offsets. The KeYi Acetabular Shells are manufactured from titanium alloy and feature a porous CP Titanium plasma porous coating. The shells feature a dome hole, are available with a two or three-hole pattern for supplemental bone screw fixation, and come in a range of outer diameter sizes. The KeYi Acetabular Liners are manufactured from ultrahigh molecular weight polyethylene (standard/non-crosslinked UHMWPE). Optional components include threaded acetabular dome hole plugs and acetabular cancellous bone screws, all manufactured from titanium alloy.

The proposed KeYi Spinal Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (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, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

The KeYi Spinal Fixation System implant consists of a variety of shapes and sizes of rods, screws and cross-connectors which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The proposed device is made of Titanium Alloy (Ti6Al4V) which meets ASTM F136-13 and CoCrMo which meets ASTM F1537-11. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 106 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.

Locking Plate System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur, tibia and fibula.

The proposed product, Locking Plate System, contains (1) Locking Plates, (2) Locking 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 R50250, 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-6 Aluminum-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.