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The KP Protective Face Mask is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate material.

The KP Protective Face Mask is a non-sterile, single-use surgical mask intended to cover the user's nose and mouth, providing a physical barrier to fluids, microorganisms, and particulate matter.

The mask consists of three nonwoven polypropylene layers, including:

• Outer layer: Spunbond non-woven
• Filter layer: Melt-blown polypropylene
• Inner comfort layer: Spunbond non-woven
• Nose wire: Polypropylene-clad adjustable wire
• Attachment: Elastic earloops (A mixture of nylon and polyurethane)

The mask is white, flat-fold style, supplied non-sterile, and packaged in standard pouches.

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KHEIRON® Spinal Fixation System including patient specific K-ROD is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, KHEIRON® Spinal Fixation System including patient specific K-ROD is indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, KHEIRON® Spinal Fixation System including patient specific K-ROD is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.

This system is intended to be used with autograft and/or allograft.

Pediatric pedicle screw fixation is limited to a posterior approach.

Patient specific K-ROD devices are compatible with NuVasive Reline System components that are only compatible with Ø5.5mm and/or Ø6.0mm rods as well as screws Ø4.5mm or larger and at least 25mm in length.

Patient specific K-ROD devices are compatible with Seaspine Mariner System components that are compatible with Ø5.5mm and/or Ø6.0mm rods as well as screws Ø4.5mm or larger and at least 25mm in length.

Patient specific K-ROD devices are compatible with Vital™ Spinal Fixation System components that are compatible with Ø5.5mm and/or Ø6.0mm rods as well as screws Ø4.0mm or larger and at least 20mm in length.

S.M.A.I.O.'s patient specific K-ROD is part of the 510(k) cleared KHEIRON® Spinal Fixation system (K211981, K232650, K251804) designed for stabilization and correction of chronic instability or deformity of the thoracic, lumbar, and sacral spine. The patient specific K-ROD is made from Ti-6Al-4V ELI per ASTM F136 and is available in diameters of 5.5 and 6.0 mm.

The Vital™ Spinal Fixation System is a 510(k) cleared pedicle screw system (K240539) that consists of a variety of screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors, and general instruments. Implant components are available in a variety of sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The Vital™ Spinal Fixation System is designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine. The Vital™ Spinal Fixation System is also used to treat severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft.

The purpose of this Special 510(k) Device Modification is to extend S.M.A.I.O.'s patient specific K-ROD (K211981, K232650, K251804) for use with the Vital™ Spinal Fixation System (K240539).

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The KLS Martin Pure Pectus System is indicated for use in surgical procedures to repair pectus excavatum. It is indicated for use in adult and pediatric (children and adolescents) populations.

The KLS Martin Pure Pectus system consists of metallic implants comprised of straight and angled pectus bars and connector bars that provide support to the thoracic cavity undergoing repair for pectus excavatum. The implants are provided non-sterile in multiple sizes and are manufactured using traditional manufacturing methods. Pectus bars are manufactured from CP Titanium. Connector bars are manufactured from Ti-6Al-4V. The system also includes the necessary instruments to facilitate placement of the implants.

The purpose of this submission is as follows:

1. Line extension to include longer pectus bar sizes for both angled and straight pectus bars ranging greater than 380 mm and less than/equal to 500 mm

2. Add "MR Conditional" to the device labeling for the angled and straight pectus bars ranging greater than 380 mm and less than/equal to 500 mm used in conjunction with connector bars

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The Flexible Intubation Video Endoscope – Sterile (FIVE-S) is intended for use by physicians for endotracheal intubation and diagnostic and therapeutic procedures in bronchoscopy. The Karl Storz Video Bronchoscope is intended to provide visualization via a video monitor.

E-Box: the product serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.

The videoscopes in the modified Flexible Intubation Video Endoscope – Sterile (FIVE-S) is sterile single-use, flexible video-endoscopes. The distal tip houses the CMOS (Complementary Metal Oxide Semiconductor) imaging sensor and the LED light source. The raw data captured at the distal tip CMOS imaging censor is transferred to the E-Box adaptor (when using the Image1 S CCU), where it is converted to a standard NTSC (National Television System Committee) video signal by the PCB (Printed Circuit Board), which is then driven into the compatible CCU (Camera Control Unit) for further processing and video formatting for output to a display monitor. The videoscopes and E-Box are powered by the CCUs through the connecting cords.

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This device is an intravascular administration set with a non-coring Huber needle used for drug administration and blood sampling through implanted vascular port systems.

The needle tip is equipped with an anti-needle stick protector to reduce the possibility of accidental needle sticks. This device is also applicable to high-pressure injection with power injectors, when used with a port system indicated for high-pressure injection.

The K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing (here in after K-SHIELD Advantage HP-PAIS) is an intravascular administration set with a non-coring Huber needle used for drug administration and blood sampling through implanted vascular port systems.

The needle tip is equipped with an anti-needle stick protector to reduce the possibility of accidental needle sticks. This device is also applicable to high-pressure injection with power injectors, when used with a port system indicated for high-pressure injection.

This device has a Huber needle for insertion into the septum of an implanted port, for infusion and blood sampling through the port. This needle is equipped with wings of a specific shape and rigidity to ensure that the user can securely hold the device during needle insertion and withdrawal. Additionally, the alignment of the gripping position and the puncture point along a straight line supports accurate puncture placement. The device features a safety mechanism that activates upon needle withdrawal, with a safety shield covering the needle tip.

The activation of the safety mechanism is audibly confirmed by a click sound. Moreover, the device is equipped with high-pressure resistant tubing and clamp, enabling the supply of medications such as contrast media using an automatic injector.

Specification

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The KARL STORZ Cholangiography Set consists of manually operated reusable surgical devices intended for use by qualified surgeons in minimally invasive intraoperative cholangiography in adults and pediatric patients ≥ 13 years of age.

The KARL STORZ Cholangiography Set are manually operated reusable surgical devices consisting of: Cholangiography Fixation Clamp, Guide Tube for Cholangiocatheter, and BERCI Plastic Stylet. The KARL STORZ Cholangiography Set includes devices which are used to facilitate the execution of cholangiograms (x-ray pictures of the bile ducts) during endoscopic surgery.

The Cholangiography Fixation Clamp, Guide Tube for Cholangiocatheter, and BERCI Plastic Stylet work together to ensure accurate and clear cholangiography during minimally invasive procedures.

• The Cholangiography Fixation Clamp secures the catheter in place after insertion, preventing movement and ensuring proper positioning.
• The Guide Tube provides a smooth, controlled pathway for the catheter during insertion.
• The BERCI Plastic Stylet eliminates metal shadows by remaining in place when the metal trocar sheath is removed, preserving clear X-ray imaging of the biliary system.

The devices facilitate precise catheter placement, reduce interference in imaging, and maintain optimal procedure conditions for successful cholangiography.

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The KLS Martin IPS Forearm System is indicated for use in forearm fractures, osteotomies, and arthrodeses. It is intended for adults, as well as adolescents (12-21 years) and children (2-12 years) in which growth plates have fused or will not be crossed by fixation.

The KLS Martin Individual Patient Solutions (IPS) Forearm System is comprised of additively manufactured, patient-specific models, guides and metallic bone plates. The plates will be used in conjunction with previously cleared metallic bone screws and locking pins for internal fixation, alignment, stabilization, reconstruction, and/or corrective osteotomies of the radius and/or ulna. The devices are designed and manufactured to be patient-specific based on the electronic medical image of the patient's anatomy; with input from the physician during virtual planning, prior to finalization, and prior to production of the device. The physician provides input for model manipulation and interactive feedback by viewing digital models of planned outputs that are modified by trained KLS Martin engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated implant over a 3D model of the patient's anatomy to ensure its dimensional properties allow an appropriate fit.

Implants are provided non-sterile and are manufactured using additive methods from Ti-6Al-4V. The system also includes the necessary fixation devices and instruments to facilitate placement of the implants.

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KLS-Martin Micro Osteosynthesis System (1.5MM): The KLS-Martin Micro Osteosynthesis System (1.5MM) is used in oral-maxillo-cranio-facial surgery to stabilize fractured bone structures. The bone segments are attached to the plate with screws to prevent movement of the segments.

KLS Martin Centre-Drive Drill-Free Screw: The KLS Martin Centre-Drive Drill-Free Screws are intended for use in rigid internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates which are contoured to fit the bony surface and stabilize the bone fragments. The addition of the self drilling feature is the only difference between the submitted device and the predicate device referenced.

KLS Martin Rigid Fixation - Sterile: The KLS Martin Rigid Fixation - Sterile is intended to provide, in sterile packaging, osteosynthesis products with the following indications for use:

• The RESORB-X® SF Sonotrode is only intended for use for insertion of the RESORB-X® SF pins.
• The KLS Martin Mandibular/Reconstruction System II is intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction.
• The KLS Martin Centre-Drive Drill-Free screws are intended for use in rigid internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates which are contoured to fit the bony surface and stabilize the bone fragments. The addition of the self drilling feature is the only difference between the submitted device and the predicate device reference
• The KLS-Martin Micro Osteosynthesis System is used in oral-maxillo-cranio-facial surgery to stabilize fractured bone segments. The bone segments are attached to the plate with screws to prevent movement of the segments.
• The KLS-Martin Micro Osteosynthesis System is used in oral-maxillo-cranio-facial surgery to stabilize fractured bone segments. The bone segments are attached to the plate with screws to prevent movement of the segments.

Individual Patient Solutions - Ti (IPS-Ti)*: Individual Patient Solutions - Ti (IPS-Ti) is intended to replace bony voids in the mandibular, maxillofacial or craniofacial skeleton.

Individual Patient Solutions - PEEK (IPS-PEEK)*: Individual Patient Solutions - PEEK (IPS-PEEK) is intended to replace bony voids in the cranial and/or craniofacial skeleton.

Individual Patient Solutions - (IPS-PEEK):** The Individual Patient Solutions - (IPS-PEEK) is intended to replace bony voids in the cranial skeleton.

KLS-Martin Micro Osteosynthesis System (1.5mm): The KLS-Martin Micro Osteosynthesis System is designed to aid in the alignment and stabilization of the bones of the skeletal system after a facial fracture or surgery. The bone plate system is composed of bone plates and screws of various shapes and sizes for use in oral-maxillo-cranio-facial surgery. The bone plates are manufactured from CP Titanium and range in thickness from 0.3mm - 1.0mm. The bone screws are manufactured from Titanium Alloy and range in diameter from 1.5mm - 1.8mm.

KLS Martin Centre-Drive Drill-Free Screw: The KLS Martin Centre-Drive Drill-Free Screws are designed to eliminate the need for pre-drilled pilot holes. They are self-tapping with one step insertion. They are intended for use in rigid internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates where are contoured to fit the bony surface and stabilize the bone fragments. The bone screws are manufactured from Titanium Alloy and range in diameter from 1.0mm - 2.0mm.

KLS Martin Rigid Fixation - Sterile: The KLS Martin Rigid Fixation - Sterile includes titanium plates of various shapes and thickness, titanium screws of various length and diameter, stainless steel twist drills of various length and diameter and stainless steel sonotrode tips that are provided in sterile packaging. The KLS Martin Rigid Fixation - Sterile is intended to provide KLS Martin's previously cleared osteosynthesis products in sterile packaging.

Individual Patient Solutions - Ti (IPS-Ti)*: The Individual Patient Solutions - Ti (IPS-Ti) is a preformed implant manufactured from Titanium material. The implant is pre-shaped to fit the anatomy of the patient using a CT-based model of the patient's skull. The PCI-PEEK is fixated to native bone using previously cleared KLS Martin titanium plates and screws.

Individual Patient Solutions - PEEK (IPS-PEEK)*: The Individual Patient Solutions - PEEK (IPS-PEEK) is a preformed implant manufactured from PEEK material. The implant is pre-shaped to fit the anatomy of the patient using a CT-based model of the patient's skull. The PCI-PEEK is fixated to native bone using previously cleared KLS Martin titanium plates and screws.

Individual Patient Solutions - (IPS-PEEK)**: The Individual Patient Solutions - (IPS-PEEK) is a preformed implant manufactured from PEEK material offered to the end-user as a sterile product. The implant is pre-shaped to fit the anatomy of the patient using a CT-based model of the patient's skull. The PCI-PEEK is fixated to native bone using previously cleared KLS Martin titanium plates and screws.

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