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1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. For cemented and un-cemented use.

The E-Poly™ Tibial Bearings are provided in five sizes. Each size comes in five thicknesses. (There are five basic styles of the E-Poly™ Bearings which are intended to be unsel with previously cleared Biomet knee products.) The E-Poly™ UHMWPE tibial bearings are highly-crosslinked to improve wear resistance, and infused with vitamin E to stabilize free-radicals and prevent oxidative degradation.

The InnerVue™ Diagnostic Scope System is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. Examples of generic surgical use include the visualization of joints within the body. These joints can include, joints located in the torso/trunk, upper/lower extremities, and the temporomandibular joint.

The InnerVue™ Diagnostic Scope System consists of five (5) main parts: hardware, software, instrumentation and procedural kit(s). Hardware: The hardware consists of the following components: Monitor, keyboard, image processor, Xenon light source, camera unit, power supply, printer, handpiece (which incorporates the camera head and light cable), a slide-out working surface and a storage drawer. Software: The software enhances the image from the scope to remove fiber optic pixilation without adding distortion. The software allows the operator to record and print still images as well as record and archive audio and video information recorded during the procedure. Scope: A rigid fiber optic scope designed for one-time use. Supplementary Instruments: Supplementary instruments consist of four (4) pieces that can be used interchangeably throughout the procedure. The four components are a cannula, a trocar, and a cannula plug. Both disposable supplementary instruments are available with the system. Procedural Kits: Supplementary items to assist in the surgical procedure.

Indications for the LactoScrew™ Screw Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows: Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tendodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction. Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, halluxvalgus reconstruction, mid- and forefoot reconstruction. Elbow: Tennis elbow repair, ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction. Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tendodesis, and patellar ligament/ tendon repair.

This device is a screw anchor used to provide a means for attaching soft tissue to bone during healing. The device consists of a screw portion and a head portion. The screw portion engages the bone while the head portion provides a means to drive the anchor in and a means to attach the suture to the anchor. These anchors are comprised of 85% L-Lactide/15% Glycolide and are available in 3.5 mm and 5.5 mm diameter sizes.

Calcigen™ PSI bone graft substitute is indicated for bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. Calcigen™ PSI bone graft substitute can be combined with autogeneous bone marrow aspirate or autogenous blood. Calcigen™ PSI resorbs and is replaced with bone during the healing process.

Calcigen™ PSI bone graft substitute is a resorbable osteoconductive scaffold composed of 60% hydroxyapatite (HA) and 40% tri-calcium phosphate (TCP). The device is available as granules, cubes, or cylinders. Calcigen™ PSI is porous with multidirectional interconnected pores resembling that of cancellous bone.

Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative joint disease.

A surgeon will request a PMI hip stem over a standard line product in order to better fill the patient's natural femoral canal. The most common parameters modified include the expansion of the A-P diameter, the increase of the lateral flare of the device and the posterior bowing of the stem. The resulting device will more closely match the patient's natural anatomy. Since each stem is matched to a particular patient, a specific device description is unavailable. Instead, an envelope has been defined which all devices must fit.

The Propeller Head Small Cannulated Screw System is indicated for the following conditions: - Fixation of fractures in long bones such as the fibula, tibia, humerus, radius and ulna . as well as fractures in the patella. - Fixation of the small bones such as those in the foot, ankle, wrist and elbow. ● - . Ligament reconstruction - Arthrodesis of the foot, ankle, wrist and elbow. . - Small bone osteotomies . - Osteochondritis dissecans

The Propeller Head Small Cannulated Screw System is a titanium screw that has cutting flutes in the head, which allows it to cut into the bone, thus countersinking itself. The screw is also cannulated to allow insertion over a quide wire. The threads are selfdrilling and self-tapping.

The Comprehensive Humeral Fracture Stems are indicated for 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Revision where other devices or treatments have failed; 4) Correction of functional deformity; 5) Fractures of the proximal humerus, where other methods of treatment are deemed inadequate; and 6) Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate. The Interlok® finish Comprehensive Humeral Fracture Stems are intended for cemented use and the MacroBond™ coated Comprehensive Humeral Fracture Stems are intended for press-fit or cemented application.

The Comprehensive Humeral Fracture Stems consists of various lengths and can be provided with an Interlok® finish for cement fixation or with a thin layer of plasma spray coating known as MacroBond™ for press-fit. The device is fluted distally which allows for a cement mantle and an increase in anti-rotational stability. The proximal body of the stem incorporates a reverse Morse taper for the Bio-Modular Heads and 4 fins, three of which include suture holes to facilitate multiple attachment sites for the bone. A collar also exists to minimize subsidence.

Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis, and rheumatoid arthritis. The device is a single use implant intended for press-fit application.

The Press-Fit Head Resurfacing device is designed to replace the outer surface of the femoral head while preserving as much natural bone as possible. The device retains the diameter of the natural femoral head and articulates aqainst the natural acetabulum (hemi-hip). The device is manufactured from cobalt alloy (Co-Cr-Mo) conforming to ASTM F-75. It has a highly polished outer surface and a titanium plasma spray coated inner surface. A central post is provided for stabilization. The device is available in diameters of 38mm to 60mm, in one-millimeter increments.

The products found in the original 510(k) K950761, and K954417 will use the following Indications for Use: 1) NonInfiammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) Rheumatoid arthritis, 3) Correction of functional deformity, 4) Revision procedures where other treatments or devices have failed and 5) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head Involvement, unmanageable using other techniques. For Cemented and Non-cemented use The products found in the original 510(k) K920639, K920640 and K926107 will use the following Indications for Use: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) Rheumatoid arthritis, 3) Correction of functional deformity, 4) Revision procedures where other treatments or devices have failed and 5) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. For Cemented use only The products found in the original 510(k) K921274 will use the following Indications for Use: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) Rheumatoid arthritis, 3) Correction of functional deformity, 4) Revision procedures where other treatments or devices have falled and 5) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. For Non-Cemented use only The products found in the original 510(k) K970501 will use the following Indications for Use: Intended for use in reconstruction of the hip joint due to disease, deformity of trauma. The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnoses. The device is a single use implant

Biomet's polyethylene components are manufactured from UHMWPE (GUR 1050) resin conforming to ASTM F-648, ISO 5834-1, and ISO 5834-2. This resin is isostatically compression molded under constant temperature and pressure and formed into acetabular components, which are designed to replace the articulating portion of the hip joint.