Profile: Biomet, Inc designs and manufactures products for hip replacement, knee replacement, shoulder replacement, elbow replacement & other small joint replacements. We are an ISO 9001 CE certified company. We offer products like joint replacement, sports medicine & dental implants. We encourage you to talk to your doctor about options that could help you get back to living and keep you active. If you have suffered from a sports related or other injury, we can help. Sports knee injuries and the available treatment options is the first step to making an informed decision about your healthcare and your quality of life. Our recommendation is to see an orthopedic physician who, after an examination, can give you the appropriate treatment options for your medical condition. Our Repicci II® implant system resurfaces only the damaged section of cartilage, thus saving a healthy cartilage. Our BioSymMetRic™ PIP fixator is a device that uses pins placed through the finger bone to stabilize complex finger fractures.

The company was founded in 1977, has revenues of > USD 1 Billion, has ~20 employees and is ISO 9001, CE certified. NASDAQ:BMET (SEC Filings)

FDA Registration Number: 1825034

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• Soft Sacroiliac Orthosis (FDA Code: IPW / 890.3490) A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.

• Soft Tissue Biodegradable Fixation Fastener (FDA Code: MAI / 888.3030) Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

• Soft Tissue Non-Biodegradable Fixation Fastener (FDA Code: MBI / 888.3040) A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

• Sonic Surgical Instrument and Accessory (FDA Code: JDX / 888.4580) A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.

• Spare Hook for K Nail Extractor

• Specialty Drapes

• Spinal Fixation Device

• Spinal Fixation Device Implant (FDA Code: JDN / 888.3060) A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct "sway back," scoliosis (lateral curvature of the spine), or other conditions.

• Spinal Interlaminal Fixation Appliance (FDA Code: KWP / 888.3050) A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

• Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ / 888.3060)

• Spinal Pedicle Fixation Orthosis (FDA Code: MNI / 888.3070) Pedicle screw spinal systems are multiple component devices, made from a variety of materials, including alloys such as 316L stainless steel, 316LVM stainless steel, 22Cr-13Ni-5Mn stainless steel, Ti-6Al-4V, and unalloyed titanium, that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of anchors (e.g., bolts, hooks, and/or screws); interconnection mechanisms incorporating nuts, screws, sleeves, or bolts; longitudinal members (e.g., plates, rods, and/or plate/rod combinations); and/or transverse connectors.

• Spinal Pedicle Fixation Orthosis For Degenerative Disc Disease (FDA Code: NKB / 888.3070)

• Spine & Lumbar Orthoses

• Spine Fusion Stimulators

• Spine Supports

• Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH / 888.3070)

• Square Nail Extractor Hook

• Stabilized Total Knee Systems

• Stable Femoral Components

• Stainless Steel Bone Mallet

• Stainless Steel Spinal System

• Sterile Surgical Drapes (FDA Code: KKX / 878.4370) A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

• Sternal Wire Twister

• Strap Arm Sling

• Supracondylar Cable Plate

• Surgeon's Gloves (FDA Code: KGO / 878.4460) A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.

• Surgical Apparel Accessories (FDA Code: LYU / 878.4040) Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

• Surgical Bit (FDA Code: GFG / 878.4820) Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

• Surgical Contractor (FDA Code: FZR / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Surgical Drapes (FDA Code: KKX / 878.4370)

• Surgical Drapes & Packs (FDA Code: KKX / 878.4370)

• Surgical Drills

• Surgical Drills & Reamers

• Surgical Equipment, Blades & Burrs

• Surgical Exhaust Apparatus (FDA Code: FYD / 878.5070) Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.

• Surgical Gowns (FDA Code: FYA / 878.4040)

• Surgical Gowns

• Surgical Hammer (FDA Code: FZY / 878.4800)

• Surgical Hand Pieces

• Surgical Instrument (Miscellaneous Medical)

• Surgical Instrument Tray (FDA Code: FSM / 878.4800)

• Surgical Instruments, Portal Instruments

• Surgical Instruments, Wire Twisters

• Surgical Lamps (FDA Code: FTD / 878.4580) A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

• Surgical Lights (FDA Code: FTD / 878.4580)

• Surgical Marking Pens (FDA Code: HRP / 886.4570) An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the location of ocular or scleral surgical manipulation.

• Surgical Mesh (FDA Code: FTM / 878.3300) Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

• Surgical Navigation

• Surgical Navigation Interface/Display

• Surgical Navigation Systems