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The OsteoRemedies Hip Spacer System consists of modular heads and stems, and optional acetabular cups. The REMEDY® components of the OsteoRemedies Hip Spacer System include gentamicin and the REMEDY SPECTRUM® GV components include gentamicin and vancomycin.

The OsteoRemedies Hip Spacer System is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin or gentamicin/vancomycin are the most appropriate antibiotics based on the susceptibility pattern of the infecting micro-organism(s).

Following removal of the existing femoral and acetabular components and radical debridement, the head and stem components are inserted into the femoral medullary canal and can mate directly with the native acetabulum or an acetabular component which is placed in the acetabular cavity. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The OsteoRemedies Hip Spacer System is not intended for use for more than 180 days, at which time all components must be explanted, and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.).

The OsteoRemedies' REMEDY Hip Spacer and REMEDY SPECTRUM GV Hip Spacer families (K112470, K172906, K191981, K192995) are legally marketed devices that are used in skeletally mature patients undergoing a two-stage procedure due to a septic process.

The 510(k)-cleared Hip Spacer is a temporary hip spacer device consisting of independent components (femoral stem, head, and cup components). All hip spacer constructs include component(s) manufactured from PMMA with gentamicin (REMEDY Hip Spacers) or PMMA with gentamicin and vancomycin (REMEDY SPECTRUM GV Hip Spacers); the stems are structurally reinforced with a stainless steel core.

The subject REMEDY POLY+PLUS Acetabular Cup and REMEDY CoCr Modular Femoral Head Components are intended to be a line extension to the REMEDY Hip Spacer and REMEDY SPECTRUM GV Hip Spacer families (K112470, K172906, K191981, K192995).

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The MC2 Portable X-ray System is indicated for use by qualified/trained medical professionals on adult and pediatric patients for:

• Handheld orthopedic radiographic procedures of the extremities.
• Handheld orthopedic serial radiographic procedures of the extremities, excluding the shoulder, hip, and knee. Handheld serial radiographic imaging is limited to forward holding position only.
• Stand-mounted orthopedic radiographic, serial radiographic, fluoroscopic, and orthopedic interventional procedures of the extremities, inclusive of shoulders and knees.

The device is NOT intended for use during surgery. The device is NOT intended to replace a stationary radiographic or fluoroscopic system, which may be required for optimization of image quality and radiation exposure.

The device is to be used in healthcare facilities where qualified operators are present (e.g., outpatient clinics, urgent cares, imaging centers, sports medicine facilities, occupational medicine clinics).

The device is NOT intended to be used in environments with the following characteristics:

• Aseptic or sterile fields, such as in surgery
• Home or residential settings or other settings where qualified operators are not present
• Vehicular and moving environments
• Environments under direct sunlight
• Oxygen-rich environments, such as near an operating oxygenation concentrator

The MC2 Portable X-ray System ("MC2 System" or "MC2") is a portable and handheld X-ray system designed to aid clinicians with point-of-care visualization through diagnostic X-rays of the shoulders to fingertips and knees to toes. The device allows clinicians to select desired technique factors best suited for their patient's anatomy. The MC2 consists of two major system components: the emitter and the cassette. The MC2 emitter and cassette are battery-powered and are charged via a wired charger. The system is intended to interface wirelessly to an external tablet when used with the OXOS Device App or to a monitor with an off-the-shelf ELO Backpack and the OXOS Device App. The MC2 utilizes an Infrared Tracking System to allow the emitter to be positioned above the patient's anatomy and aligned to the cassette by the operator. The MC2 also utilizes a LIDAR system to ensure patient safety by maintaining a safe source-to-skin distance.

The MC2 is capable of three X-ray imaging modes: single radiography, serial radiography, and fluoroscopy. In single and serial radiography modes, the user can utilize the entire range of kV values (40-80kV), while fluoroscopy mode is limited to 40-64kV. In single radiography mode, the user can utilize the entire range of mAs values, while serial radiography and fluoroscopy are limited to 0.04-0.08 mAs.

The MC2 contains various safety features to ensure patient and operator safety. The primary interlocks that ensure system geometry is maintained include a source-to-image distance interlock, an active area interlock, a source-to-skin distance interlock, and a stand-mounted interlock.

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Balanced Knee® System TriMax® Porous Femoral Components are intended for single use uncemented or cemented total knee arthroplasty with the following indications:

1. Loss of joint configuration and joint function.
2. Osteoarthritis of the knee joint.
3. Rheumatoid arthritis of the knee joint.
4. Post-traumatic arthritis of the knee joint.
5. Valgus, varus, or flexion deformities of the knee joint.
6. Revision procedures where other treatments or devices have failed.

Balanced Knee® System TriMax® Porous Femoral Components are intended for use as part of total knee arthroplasty (TKA) procedures. Total knee arthroplasty is a procedure where worn, diseased, or damaged surfaces of the knee joint are removed and replaced with artificial surfaces.

The components are prescription products consisting of single use devices for implanting into patients in an operating room by a qualified surgeon.

Balanced Knee® System TriMax® Porous Femoral Components are a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy femoral component with Co-Cr-Mo sintered porous coating.

The device will have two configurations:

• Cruciate Retaining (CR) Femoral – (Substantially Equivalent to K152169)
• Posterior Stabilized (PS) Femoral – (Substantially Equivalent to K123457)

They have the same materials of constructions and the same articular geometry as the legally marketed TriMax cemented femoral components. The new feature is the addition of the CoCr porous coating on the bone contacting surfaces that is substantially equivalent to the reference device: Maxx Orthopedics Freedom Porous Femoral Component (K150680).

Balanced Knee® System TriMax® Porous Femoral Components are manufactured from cast Co-Cr-Mo per ASTM F75.

The subject device has a variety of sizes to accommodate variations in patient anatomies: left and right orientations, medial-lateral width (56 – 79.5mm), anterior-posterior width (50 – 74mm), and CR & PS variations.

Balanced Knee® System TriMax® Porous Femoral Components are compatible with BKS® High Flex PS Tibial Inserts (K123457, K131337), BKS® High Flex Patellar Button (K131337), BKS® TriMax® CR and US Tibial Inserts (K152169), and BKS® TriMax® PS Plus Tibial Inserts (K233093).

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The Vivo 45 LS ventilator (with or without the SpO2 and CO2 sensors) is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for pediatric through adult patients weighing more than 5 kg (11 lbs.), however, the mouthpiece ventilation and Auto EPAP modes are only for adult patients during non-invasive ventilation.

The Vivo 45 LS with the SpO2 sensor is intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate.

The Vivo 45 LS with the CO2 sensor is intended to measure CO2 in the inspiratory and expiratory gas.

The device is intended to be used in home, institution, hospitals and portable applications such as wheelchairs and gurneys. It may be used for both invasive and non-invasive ventilation. The Vivo 45 LS is not intended to be used as an emergency transport or critical care ventilator. The Auto EPAP feature is for use with PSV+TgV+AE mode in hospital use only.

The Vivo 45 LS Ventilator is a portable, microprocessor controlled turbine based pressure support, pressure control or volume controlled ventilator intended for the care of individuals who require mechanical ventilation.

Flow and pressure are read using flow and pressure sensors. Essential parameters such as pressure, flow and volume are presented on the ventilator screen, both in the form as graphs and numbers.

Operator actions are performed via the front panel where the buttons and an LCD screen are located (and two dedicated buttons on the top of the ventilator control starting/stopping treatment and pausing the alarm audio). There are dedicated LEDs and buttons for managing alarm conditions and an Information button which provides integrated user support.

The Vivo 45 LS can be operated by external AC or DC power supply and contains an integrated battery as well as an optional click in battery.

The Vivo 45 LS can be used with two types of patient circuits: single limb patient circuits including an active exhalation valve and single limb patient circuits including a passive leakage port.

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• Instrument for flexible endoscopy and for compression of tissue in the gastrointestinal (GI) tract, for hemostasis or for treating gastrointestinal organ wall lesions. Marking of lesions.
• The OTSCneo clip is indicated for clip placement within the GI tract for the purpose of:
  • Endoscopic marking
• Hemostasis for:
  • Mucosal/submucosal defects < 3 cm
  • Bleeding ulcers
  • Arteries < 2 mm
  • Polyps < 1.5 cm in diameter
  • Diverticuli in the colon
• Closure of GI tract luminal perforations < 20 mm that can be treated conservatively.

NOTE: The OTSCneo System Set is not indicated for stent fixation. For stent fixation, use the stentfix OTSC® System Set.

The subject device constitutes an over-the-scope clip application device used within the context of flexible endoscopy in the gastrointestinal tract. The clip application capabilities center around a memory-shape alloy clip mounted on a transparent plastic cap. Cap (and clip) are mounted on the distal end of an endoscope. Endoscopic instruments or suction are used via endoscope working channels for mobilization and retraction of target tissue into the cap lumen. With the target tissue inside the cap lumen, the memory-shape alloy clip is applied onto the target tissue using a manual thread mechanism.

Contents of the OTSCneo System Set are:

• Application cap (with spout, application ring, thread, clip mounted on the cap)
• Hand Wheel
• Thread Retriever

In line with cleared indications, clip application with the subject device can be used for hemostasis, treatment of lesions, or marking of lesions in the GI tract.

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The Single Use Cytology Brush V BC-V600P-3010 is intended to be used to collect tissue specimens in the biliary system in combination with an endoscope.

BC-V600P-3010 has been designed to collect specimens or cells endoscopically for cytologic examination in conjunction with duodenoscopes. BC-V600P-3010 is inserted into the duodenoscope through an instrument channel to reach the target area, where, by rubbing the brush on the target area, specimens or cells can be collected. BC-V600P-3010 is then withdrawn from the duodenoscope channel with the collected samples.

The handle is connected to operating wires. The grip on the handle portion controls the brush movement inside the tube. By pushing/pulling the handle, the brush at the distal end of the Subject device can be protruded from/drawn into the tube. Cells can be collected by moving over the target site with the brush.

The BC-V600P-3010 consists of:

A. Handle

• Grip: used to push to extend the brush from the tube. Pull to retract the brush back into the tube.
• Operation pipe: used to connect the grip with the wires so that it can transfer the force to push/pull the brush/distal tip.
• Locking cap: used for fixing the location of the brush by turning the locking cap clockwise.
• Injection port: Available to attach a syringe here to inject contract medium.
• Hook: attached to the boot of the endoscope or ET Control Device V (sold separately).

B. Insertion portion

• Wires: connect operation pipe with brush and distal tip to push/pull the brush from/into the tube
• Tube: works as the channel that the contrast media is injected through during use
• V marking: gives the user an approximate indication of how far the instrument has been inserted into the endoscope,
• Radiopaque marks: allow the distal end of the tube to be visualized on the X-ray monitor
• Brush: used to brush the target area to collect samples.
• Distal tip: When using a guidewire, the guidewire is inserted into the distal tip.

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The HALYARD* Adult Face Mask(s) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. These are single use, disposable device(s), provided non-sterile.

The HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops, is a three-layer mask, constructed of well-known non-woven materials. The mask is provided with earloops and a malleable nosepiece, placed within the bindings for comfort, to conform to the curvature of the wearer's nose.

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OncoPatch is indicated for the surface treatment of localized tumors. It is designed to deliver radiation therapy for the treatment of superficial lesions. It can be used either as primary treatment or as treatment for residual disease after excision of primary or recurrent tumors.

The OncoPatch device is engineered for the surface treatment of skin cancers, such as basal and squamous cell carcinoma, as well as for other skin conditions, including keloids. Using yttrium-90 (Y-90) as the radioactive source, this device delivers low-energy beta radiation directly to the skin surface, targeting cancerous or abnormal tissue while sparing underlying healthy tissue. The OncoPatch device makes use of radioactive patches constructed from thin, polymer-coated foils containing Y-90. These foils are adhered to the underside of a plastic or metal composite shield, which ensures safety for both the patient and healthcare providers during treatment. The patch and shield are coupled with an applicator. The applicator uses collimators with predetermined shapes and sizes that assume a flat patient geometry. The OncoPatch is secured temporarily to the patient surface for single or multiple treatment fractions, typically with short (< 60 min) treatment durations.

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