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The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The CONMED Argo Knotless® Anchor may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.

The CONMED Argo Knotless® Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10⁻⁶. The threaded anchor and the suture eyelet are manufactured of PolyEtherEtherKetone (PEEK) material. Each size features a single use driver, a threaded anchor, suture eyelet, a 1.0mm UHMWPE Hi-Fi™, non-absorbable retention suture, and loader tab. The retention suture holds the PEEK eyelet in place on the driver and can be incorporated into the repair if desired. A maximum of six (6) Hi-Fi #2 suture, or 1.3mm Hi-Fi ribbon suture, or (2) two limbs of Hi-Fi tape, or one (1) bioresorbable reinforced implant can be threaded through the eyelet. The repair sutures are then tensioned and cleated on the driver cleat, if deemed necessary by the surgeon. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.

The BioBrace® RC Delivery System is intended for use in rotator cuff surgical procedures for reinforcement of soft tissue where weakness exists. The BioBrace® Implant is intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during rotator cuff tendon repair surgery. The BioBrace® Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair. The Disposable Inserter is intended to facilitate the delivery and positioning of the implant during soft tissue repairs.

The BioBrace® RC Delivery System is comprised of a BioBrace® Implant pre-stitched with HI-FI® suture, a threader assembly that facilitates passing sutures through the BioBrace® Implant, and an inserter to facilitate placement of the BioBrace® Implant into the subacromial space. The previously cleared BioBrace® Implant is a bioresorbable, reinforced Implant composed of a highly porous collagen sponge made from insoluble bovine tendon type-1 collagen and reinforced with poly-L-lactic-acid (PLLA) multifilament yarn. The BioBrace® Implant is 80% porous with a median pore diameter of 19 µm. BioBrace® implants are approximately 3 mm thick and provided in two rectangular sizes of 23 x 25 mm and 35 x 25 mm. The BioBrace® RC Delivery System is single-use and supplied sterile (ETO).

The biocomposite suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The Argo Knotless® GENESYS™ Anchor may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.

The Argo Knotless® GENESYS™ Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10 °. The threaded anchor is manufactured of bioabsorbable material, and the suture eyelet is manufactured of PEEK Optima material. The device features a single use driver, a threaded anchor, a PEEK-Optima eyelet, a #2 UHMWPE, non-absorbable retention suture, and loader tab. The retention suture holds the PEEK eyelet in place on the driver and can be incorporated into the repair if desired. The suture eyelet can hold up to six (6) sutures or one (1) bioresorbable reinforced implant. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.

BioBrace® is intended for use in surgical procedures for reinforcement of soft tissue where weakness exists. BioBrace® is also intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon and ligament repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extraarticular ligaments. BioBrace® is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, soring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the repair.

The BioBrace® implant is a bioresorbable and bioinductive scaffold composed of a highly-porous collagen sponge made from insoluble bovine tendon type-1 collagen, and reinforced with poly- L-lactic-acid (PLLA) multifilament yarn (75 denier, 15 micron filament diameter). The BioBrace implant is 80% porous, average density of 0.2 grams/cm3, and median pore diameter of 19 microns. The highly porous collagen sponge comprises the majority of implant surface area (0.7 m2/gram) versus the PLA filaments alone (0.2 m2/gram), creating a large biologic matrix for cellular ingrowth, tissue regeneration, and healing. BioBrace implants are approximately 3 mm thick, provided in multiple sizes, and provide for soft tissue and tendon augment, and clinically relevant strengthening of the surgical repair. The BioBrace implant is single-use and supplied sterile with SAL of 10-6.

The CONMED PlumeSafe® X5™ Smoke Management System is designed to remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures.

The PlumeSafe® X5™ Smoke Management System is a portable, stand-alone, capital unit, that when paired with a reusable filter and disposable accessories makes up a Smoke Management System. The smoke unit is accompanied by a reusable filter and is available in two different configurations, a 22mm or 25mm size. Each filter is designed to capture components of surgical smoke and return clean air to the environment and can connect to different accessories which include pencils, adapters, fluid traps, and tube sets. Each filter is a seff-contained device that is completely enclosed to protect health care personnels from potential contamination during filter changes. Each filter is comprised of filtration (gross particulate pre-filter, Ultra-Low Penetration Air (ULPA), coconutbased carbon, impregnated alumina, and carbon dust capture media) that produce capture efficiency ratings equal to or better than 99.999% for particles ranging in size from 0.01μm to 0.2μm. PlumeSafe® X5™ is comprised of a vacuum motor, aluminum, steel, and plastic components combined with sound reducing insulation. The vacuum motor is used to draw the surgical site, through an accessory, and into the PlumeSafe® X5™ filter. The PlumeSafe® X5™ Smoke Management System provides multiple modes (open, laparoscopic, and pencil) and settings to adjust the flow to the clinical need.

Argo Knotless® GENESYS™ SP Anchor The biocomposite suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The Argo Knotless® GENESYS™ SP Anchor may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaqed soft tissue, in conjunction with appropriate postoperative immobilization throughout the healing period. Argo Knotless® GENESYS™ Anchor The biocomposite suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The Argo Knotless® GENESYS™ Anchor may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.

Argo Knotless® GENESYS ™ SP Anchor: The Self-Punching (SP) Argo Knotless® GENESYS™ Anchor is an implantable bone anchor, that is supplied for single use, sterilized via ethylene oxide (ETO) to a SAL of 10 °. The threaded anchor is manufactured of bioabsorbable material, and the broaching tip (suture eyelet) is manufactured of titanium material. Each size features a single-use driver, the threaded anchor, a Titanium suture eyelet, a UHMWPE 1.0mm non-absorbable retention suture, and loader tab. The retention suture holds the titanium eyelet in place on the driver assembly and can be incorporated into the repair if desired. The suture eyelet can hold up to six (6) sutures. Argo Knotless® GENESYS ™ Anchor: The Non-Self-Punching Argo Knotless® GENESYS™ Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10 °. The anchor configuration requires a pre-prepared bone hole. The threaded anchor is manufactured of bioabsorbable material, and the suture eyelet is manufactured of PEEK material. Each size features a single use driver, a threaded anchor, a PEEK suture eyelet, a #2 UHMWPE, non-absorbable retention suture, and loader tab. The retention suture holds the PEEK eyelet in place on the driver and can be incorporated into the repair if desired. The suture eyelet can hold up to six (6) sutures. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation. Argo Knotless® GENESYS ™ Anchor: The Preloaded Argo Knotless® GENESYS™ Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10 °. The threaded anchor is manufactured of bioabsorbable material, and the suture eyelet is manufactured of PEEK material. The eyelet is held on with a #2 UHMWPE, nonabsorbable retention suture and supplied with either a white/black or blue/blue colored non-absorbable Hi-Fi suture tape, a retention suture, and loader tab. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation. Principle of Operation - soft tissue to bone fixation

CONMED CleanSeal Vessel Sealers are intended to be used in open and mimimally invasive procedures for the ligation and division of tissue bundles, lymphatics, and vessels up to and including 6 mm vessels (arteries, veins, pulmonary arteries, pulmonary veins). The handpiece is indicated for use in gynecological and general surgical procedures, including urologic, thoracic, and vascular. These procedures include, but are not limited to, hysterectomies, colectomies, Nissen fundoplication, and adhesiolysis. CleanSeal vessel sealer has not been shown to be effective for ubal sterilization or tubal coagulation for sterilization procedures. Do not use CleanSeal vessel sealer for these procedures.

CleanSeal Advanced Bipolar Vessel Sealer Maryland is designed to be used, with a compatible MEP-1 electrosurqical generator, in open and minimally invasive procedures for the ligation and division of tissue bundles, lymphatics, and vessels up to and including 6 mm arteries and veins. They are sterile, single use bipolar vessel sealing hand pieces featuring double action non-stick coated jaws, three shaft length options, a one-hand controlled handle with latchable lever. The instrument creates a seal by application of radio frequency (RF) electrosurgical energy to vascular structures or tissue bundles interposed between the jaws.

AirSeal iFS System: The ConMed AirSeal® iFS System is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstruction-free path of entry for endoscopic instruments, and to evacuate surgical smoke. It is indicated for use in abdominal, thoracic, and pediatric procedures where insufflation is desired to facilitate the use of various thoracoscopic and laparoscopic instruments by filling the abdominal or thoracic cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. This instrument can also be used to insufflate the rectum and colon to facilitate endoscopic observation, diagnosis, and treatment. The trocar of the AirSeal® iFS System is indicated for use with or without visualization. AirSeal dV Solution: The AirSeal Robotic Solution (ARS) is intended for use in diagnostic and/or therapeutic endoscopic procedures in conjunction with the ConMed AirSeal iFS and an Intuitive da Vinci X Cannula and Cannula Seal to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstruction-free path of entry for endoscopic instruments, and to evacuate surgical smoke. It is indicated for use in abdominal, thoracic, and pediatric procedures where insufflation is desired to facilitate the use of various laparoscopic and thoracoscopic instruments by filling the abdominal or thoracic cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. The Cannula Cap is indicated for use with or without visualization. The ARS System must be used with the Intuitive da Vinci X 8mm Instrument Cannula, an Intuitive Cannula Seal and the AirSeal iFS in AirSeal mode. When used in AirSeal mode, the Cannula Cap and Bifurcated Tube Set are designed to provide CO2 gas delivery with stable pneumoperitoneum and continuous smoke evacuation during robotic assisted laparoscopic and thoracoscopic procedures using the da Vinci Xi or da Vinci X systems. The Bifurcated Filtered Tube Set is used to connect the Cannula Cap and Cannula Seal to the AirSeal iFS.

The ConMed AirSeal iFS System consists of the following major components: (1) a trocar, (2) a cannula, (3) tube sets, and (4) a microprocessor-controlled insufflation, recirculation and filtration unit. The cannula, trocar and tube sets are sterile, single-use products. The AirSeal iFS System is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity. The AirSeal iFS System is designed to function in one of three (3) separate modes of operation: (a) Insufflation Mode; (b) AirSeal Mode (Adult and Pediatric); or (c) Smoke Evacuation Mode. The ConMed AirSeal dV Solution (or AirSeal Robotic Solution) consists of the following major components: (1) AirSeal® Cannula Cap with a cannula cap and an obturator (in standard and long lengths), and (2) AirSeal® Bifurcated Filtered Tube Set. The cannula cap, obturator and tube set are sterile, single-use products. The AirSeal dV Solution, in conjunction with Intuitive daVinci XiX Cannula and Cannula Seal, is operated in the Airseal Mode with the AirSeal iFS System to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstruction-free path of entry for endoscopic instruments, and to evacuate surgical smoke. The ConMed AirSeal dV Solution is a sterile, single use device, primarily composed of polycarbonate, and stainless steel.

The SnapEvac and PenAdapt is an aspiration sheath that fits over an electrosurgical pencil body and leaves the tip or blade exposed. This device is considered an accessory to an electrosurgical unit (ESU). SnapEvac and PenAdapt removes surgical smoke during surgical procedures that use ESU for cutting and cauterizing. This device is used in conjunction with a suction (vacuum) source. Contraindications: This device should not be used for microsurgery. The PlumePen® Elite, PlumePen® Ultra, and PlumePen® Pro is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. Indicated for use to remove smoke plume from the surgical site and to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the target tissue for the desired surgical effect.

The smoke evacuation devices that are the subject of this 510(k) are PlumePen Surgical Smoke Evacuation Pencils (Elite, Pro and Ultra), PenAdapt Electrosurgical Pencil Adapters and Electrosurgical Pencil Adapters. By interfacing with an effective smoke evacuation unit, these devices function as part of the system to remove smoke particles from the point of surgical activity during procedures that use an electrosurgical unit (ESU) for cutting and cauterizing. PlumePen Smoke Evacuation Pencils: The PlumePen® Elite, Pro, and Ultra family of devices are sterile, single use electrosurgical hand pieces featuring an integrated smoke evacuation channel. The devices, when connected to an electrosurgical generator and smoke evacuation system are designed to remove smoke plume generated during the use of the pencil for electrosurgical procedures. PenAdapt and SnapEvac Electrosurgical Pencil Adapters: PenAdapt and SnapEvac are sterile, single use pencil adapters which fit over standard electrosurgical pencils while keeping the blade exposed. They enable the capture and removal of smoke generated during the use of the pencil, in procedures that require cutting and cauterization, when connected to an effective smoke evacuation system.