Search Results

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. 5. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate. Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure. Humeral components with a MacroBond® Surface Coating are indicated for either cemented or uncemented press-fit applications. Humeral components with a porous coated surface coating are indicated for either cemented or uncemented biological fixation applications. The Comprehensive® Modular Hybrid® Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement. The Comprehensive Humeral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive Fracture Stem. The Versa-Dial Humeral Head Prosthesis is intended for use only with the Comprehensive Shoulder Stems (Fracture, Primary and Revision), and the glenoid components of the Comprehensive Shoulder System. The Titanium Versa-Dial Humeral Head Prosthesis is indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy.

The Comprehensive Humeral Fracture Positioning Sleeves is composed of Polymethylmethacrylate (PMMA) and is used in conjunction with the Comprehensive Humeral Fracture System. The device is a sleeve that fits over the distal tapered end of the Comprehensive Humeral Fracture Stem and stops at a point below the fins of the stem.

The A.L.P.S. Clavicle Plating System is indicated for fixation of fractures, osteotomies and nonunions of the clavice including osteopenic bone.

The A.L.P.S. Clavicle Plating System is designed to address fractures of the clavicle. The system is comprised of plates, screws, and instruments to facilitate the installation of the implants.

Soft tissue fixation to bone, specifically during ligament reconstructive procedures. Small Cannulated Screws (4.0mm and smaller diameter) are intended for use in: 1. Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow. 2. Arthrodesis of the foot, wrist and elbow. 3. Small and long bone osteotomies. 4. Fracture fixation of small bones, small bone fragments and long bones. Large Cannulated Screws (5mm and larger in diameter) are intended for use in: 1. Fixation of fractures in long bones and long bone fragments. 2. Long bone osteotomies (femur, tibia, foot, ankle, olecranon). 3. Arthrodesis, and fracture fixation of the foot and ankle, such as Jones fractures of the fifth metatarsal, and Calcaneal fractures. Large Cannulated Screws (6.5mm and larger in diameter) are intended for use in: 1. Slipped capital femoral epiphysis 2. Pediatric femoral neck fractures 3. Tibial plateau fractures 4. SI joint disruptions 5. Intercondylar femur fractures 6. Subtalar arthrodesis 7. Fixation of pelvis and iliosacral joint. The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals and carpals of the hand. In the foot, these include procedures to correct Hallux Valgus (bunions), Hallux Varus and Hallux Rigidus, Hammer toe, Claw toe and Mallet toe.

The WasherLoc™ and No-Profile Screw and Washer Systems are internal soft tissue fixation devices that aid in arthroscopic and orthopedic reconstructive procedures. The system includes instrumentation allowing for proper preparation and placement of the soft tissue fixation device. The No-Profile Screw and Washer System includes titanium alloy (Ti-6A1-4V) screws and washers in various lengths/sizes. Both 4.5mm and 6.0mm diameter screws in lengths from 24mm to 70mm are available. The No-Profile Washers are available in 14mm, 16mm, and 18mm diameters with and without spikes. The spikes on the washers are not intended for additional fixation as used with the No-Profile screws. The WasherLoc™ Tibial Fixation System includes titanium alloy (Ti-6Al-4V) screws and washers in various lengths and sizes. Both 4.5mm and 6.0mm diameter screws in lengths from 24mm to 60mm are available. The WasherLoc™ Washers are available in 14mm, 16mm, and 18mm diameters with spikes intended for additional fixation. The Biomet Cannulated Screw System is designed for a variety of internal fixation, aiding in the alignment, stabilization, and healing of fractures or osteotomies to the skeletal system. The Biomet Cannulated Screw System has multiple variants included which fluctuate in screw diameters and lengths, and include the associated essential instruments that aid in fracture fixation. The Biomet Cannulated Screw System consists of screw variants, which are available in diameters of 3.0mm, 4.0mm, 5.0mm, 6.5mm, and 8.0mm. Each screw diameter is accompanied by instruments that are designed specifically for a given diameter. Washers are also part of the Biomet Cannulated Screw System and are sized 3.0mm, 4.0mm, 5.0mm, 6.5mm, and 8.0mm to specifically match each screw diameter. The washers are provided to add additional support under the head of the screw in situations where the bone quality is poor. Washers are also utilized for more surface area contact with the bone which needed in order to maintain proper fixation of the fracture or osteotomy. The Biomet Headless Compression and Twist-Off Screws are used for fixation of bone fractures, fusion of a joint, or bone reconstruction, osteotomies of the mid-foot bones, metatarsals and phalanges of the foot and metacarpals, phalanges and carpals of the hand. The Ti-6Al-4V alloy Biomet Headless Compression and Twist-Off Screws have multiple lengths and diameters associated with the different screws ranging from 2.0 to 3.0mm in diameter and lengths from 8 to 40mm. Both sets of screws will be available in sterile and non-sterile configurations. The screws include the associated essential instruments that aid in fracture fixation. The Biomet Headless Compression Screw is a cannulated headless screw which is inserted below the bone surface. This feature helps to minimize soft tissue irritation by sitting recessed and provides compression due to a dual thread design in the shaft and head. The Biomet Twist-Off Screw is a solid one-piece screw that has a drive shaft that has the ability to connect to a drill or large diameter pin driver. In addition, the screw incorporates a breakaway zone between the head and direct connection that allows the screw to break-off cleanly upon insertion. The Biomet Twist-Off Screw also has compression capabilities with a thread-free segment that achieves compression at the osteotomy site.

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty.

The subject devices, Distal Centralizers, are cylindrical components designed to slide onto the distal end of a cemented femoral stem prior to insertion into the femoral canal.

These devices are intended for shoulder joint arthroplasty. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy. Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation. Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The Comprehensive® Reverse Shoulder (CRS) is a total shoulder replacement system in a reverse configuration. The CRS was designed to provide a complete, seamless system based on the Comprehensive Shoulder platform by avoiding the need to remove a well-fixed humeral stem associated with a prior anatomical shoulder arthroplasty for conversion to reverse shoulder arthroplasty. This is made possible because the CRS can utilize any of the existing Comprehensive stems, including primary, revision, or fracture stems in cemented or uncemented applications. The CRS performs its function by replacing the damaged or diseased articular surfaces of the native shoulder with artificial surfaces with the intent to improve shoulder function and/or reduce shoulder pain.

The ALLthread PEEK Suture Anchor devices are intended for soft tissue fixation. The ALLthread PEEK Suture Anchors are indicated for use in soft tissue reattachment procedures in the shoulder. Specific indications for the shoulder include: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.

The ALLthread PEEK Suture Anchors are soft tissue anchors with preloaded nonabsorbable polyethylene surgical sutures used to repair and reattach soft tissue to bone and are supplied in both double and triple loaded suture configurations. The ALLthread PEEK Suture Anchors are designed to reattach soft tissue to bone in procedures in the shoulder. The purpose of this submission is: To submit a 510(k) for cumulative changes: Line extension including device configurations with 2 or 3 suture options, a white/black suture option, a white/green suture option and a tapered needle option. To update labeling in order to narrow the Indications for Use statements, describe the third suture options, and bring the Instructions for Use up to current practices; To ensure that the all of the instrumentation/accessories for use with this system are appropriately associated with a 510(k).

Titanium Interference Screws are intended for use in fixation of patellar bone grafts in ACL reconstruction.

Titanium Interference Screws are metallic bone screws used to provide fixation of patellar bone-tendon-bone grafts during anterior cruciate ligament (ACL) repair.

WIN Flexible Nail System WIN Nails (for use in pediatric patients) are to be used for treatment of long-bone fractures including non-comminuted and comminuted mid-shaft fractures, subtrochanteric fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures. This device is intended for osteosynthesis. The WIN Flexible Nail System is to be used for treatment of long-bone fractures including non-comminuted and comminuted mid-shaft fractures, subtrochanteric fractures, distal third fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures.

The subject WIN Flexible Nail System is made of titanium alloy, which has been continuously made commercially available since the 1950s. This device is to be implanted by insertion into long bones for fixation of fractures.

The ALLthread™ Titanium Suture Anchor devices are indicated for use in soft tissue reattachment procedures in the shoulder. Specific indications for the shoulder include: Bankart repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.

The ALLthread Titanium Suture Anchor is a non-resorbable suture anchor used to provide soft tissue fixation to bone during healing.

To provide fixation of soft-tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.

The TunneLoc Tibial Fixation Devices are an implant and inserter instrument system that offers components for treatment of patients that require fixation of soft tissue to bone.