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The device is intended to be used with endoscopic accessories such as a biopsy forceps and Electronic Endoscope Image Processor for endoscopy and endoscopic surgery within urinary tract and interior of the ureter and kidney.

The Flexible Ureterorenoscope System consists of a sterile Flexible Ureterorenoscope and an Electronic Endoscope Image Processor with its accessories power adapter. The Flexible Ureterorenoscope is provided sterile (sterilized by EO) and is single use.

The Flexible Ureterorenoscope consists of a head section, bending section, insertion section, operating section, electrical connection section, and built-in LED light source. The Electronic Endoscope Image Processor is powered by the main line.

The Flexible Ureterorenoscope is an endoscope instrument and is intended to be used with the Electronic Endoscope Image Processor during endoscopic procedures. The handle section features several key components, including a control lever, a handle for manipulation, a button for capturing photos or video, and a Luer port for the insertion of accessories or irrigation to the working channel.

The insertion section houses a working channel and wiring to transmit the image signals to the image processor. The distal bending section of the insertion section contains a camera lens for real-time image capture, an LED light source for illumination, and a distal outlet for the working channel.

The Electronic Endoscope Image Processor is a video processor which is intended and designed for use during endoscopic procedures. It receives and processes image signals from the endoscope and outputs signals to an external medical monitor for display.

The Electronic Endoscope Image Processor has integrated software to control the operation of the device and is a reusable device that does not require sterilization before use, as there is no direct/in-direct patient contact material. The image processor is intended to be cleaned and disinfected before use, the cleaning and disinfection method is validated and recommend in the User Manual.

The equipment is for use in a hospital or qualified medical institution. It is only to be used by skilled physicians trained in clinical endoscopic techniques and procedures.

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The Firebird SI Navigation System instruments are intended to be used during the preparation and placement of Orthofix Firebird SI Fusion System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Firebird SI Navigation instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra or pelvis can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The Firebird SI Navigation System consists of manual, surgical instruments for use with the Medtronic StealthStation Navigation System via the NavLock Tracker and SureTrak II Large Passive Fighter to assist surgeons in locating anatomical structures in minimally invasive and open procedures for preparation and placement of Firebird SI Fusion System implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement. The Firebird SI Navigation System instruments are manufactured from Stainless Steel per ASTM F899 or ASTM A564.

The Firebird SI Navigation System instruments include the following:

• Screw Driver
• Drills
• MDT Inline Adapter

The Firebird SI Navigation System instruments are to be used with the following FDA cleared SeaSpine Spinal System:

• Firebird SI Fusion System

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The Freedom® Total Knee System is indicated for the following:

• Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Correction of functional deformities.
• Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy.
• Moderate valgus, varus, or flexion trauma.
• Knee fractures untreatable by other methods.
• Revision surgery where sufficient bone stock and soft tissue integrity are present (For PCK Components, and Primary PCK Components, and Metaphyseal Cones only).

The Freedom Porous Tibial Base Plate, and Cementless Femoral Components, and Metaphyseal Cones are indicated for Cemented or Uncemented use. All other components are indicated for cemented use only.

The Freedom Metaphyseal Cones are additionally indicated for use in addressing tibial bone voids and/or metaphyseal reconstruction.

The subject device, Freedom Knee Metaphyseal Cone implants, is a component addition to the cleared Freedom Total Knee System for addressing tibial bone voids and/or metaphyseal reconstruction. The Freedom Knee Metaphyseal Cone implants are designed with an elliptical shape, scaling larger in the Medial-Lateral (ML) direction than the Anterior-Posterior (AP) direction. The sizes are driven by the ML size, ranging from 25mm to 60mm wide in the ML direction and 29mm to 36mm AP in the AP direction. The cones are all 30mm long and feature a stepped design to further enhance the stability in the proximal-distal direction.

The Freedom Knee Metaphyseal Cone implants feature a large internal diameter to accept the largest possible Freedom Knee Stemmed Tibial Baseplate and Stem Extension possible. The internal diameters grow larger with each implant size, and all feature cement pockets to enhance the stability of the eventual TKA construct. The cone implants also feature 12mm wide relief slots to accept the fins/keel of the Freedom Knee Tibial Baseplate.

The AP and ML sides of the cone implants (which contact the metaphyseal bone) feature a 1mm thick proprietary scaffold structure. This structure, only possible via the additive manufacturing process, is designed to mimic the size and porosity of cancellous bone. The implant is comprised of Ti6Al4V ELI metal certified to ASTM F3001 and is manufactured with significant surface roughness to further add to the hydrophilic nature of the implant.

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The Freeprint® denture flex is a light-curable polymerizable resin intended to be used in conjunction with extra-oral curing light equipment. The Freeprint® denture flex is indicated for the fabrication, by additive manufacturing, of dental objects such as flexible partial removable dentures.

Freeprint® denture flex is a light-cured, 3D printed flexible denture resin. The Subject device is used by a dental professional (dentist or dental technician) in the CAD/CAM manufacturing of patient-specific partial dentures. There are two models of the Subject device which are referred to as Freeprint® denture flex clear and Freeprint® denture flex pink-transparent. The Subject device is a viscous solution consisting of methacrylate-based resins, photo initiators and pigment and is provided in an HDPE bottle.

The Subject device resin is used within a validated manufacturing workflow to create the intended dental device. Dental devices fabricated using the Subject device are one-time use, prescription-only devices.

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The Freedom Infinia™ Total Knee System is indicated for the following:

• Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Correction of functional deformities.
• Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy.
• Moderate valgus, varus, or flexion trauma.
• Knee fractures untreatable by other methods.
• Revision surgery where sufficient bone stock and soft tissue integrity are present. (For PCK Components and Primary PCK Components only)

The Freedom Infinia™ Total Knee System components are intended for cemented and single use only. The Freedom Infinia™ Cementless Femoral (CR and PS) Components and Porous Tibial Base Plates are additionally indicated for cementless biological fixation application.

The Freedom® Total Knee System is comprised of a femoral component, all-poly tibial component, patellar component, tibial base plate and tibial articular surface. The Freedom® Total Knee System's Femoral Component is offered as different versions such as stemmed PCK design, primary PCK, cruciate retaining, posterior stabilizing. The Freedom® Total Knee System's Tibial Base Plate is offered with stemmed design and without stemmed design. The Freedom® Total Knee System was originally cleared under the 510(k) number K082019. Later on, several modifications were made and were cleared under 510(k)s K090411, K091280, K111785, K131481, K150680, K182574, K192148, K241597, K243277, K251717 respectively.

This submission seeks the clearance of an additional brand, Freedom Infinia™ Total Knee System.

Below is the description of the Freedom Infinia™ Total Knee System's components.

Freedom Infinia™ Femoral Component

The Freedom Infinia™ Total Knee System's Femoral Component is offered in both cruciate retaining and posterior stabilizing designs. The Femoral components are available in right and left configurations, and eight sizes to accommodate varying anatomy. The Freedom Infinia™ Total Knee System's Femoral Component is fabricated from Cobalt-Chromium-Molybdenum (CoCrMo) alloy complying with ASTM F75 and is intended for cemented application to replace the articulating surface of the distal femur in a measured resection.

Freedom Infinia™ Cementless Femoral Component

The Freedom Infinia™ Total Knee System's Cementless Femoral Component is offered in both cruciate retaining and posterior stabilizing designs. The Cementless Femoral Components are available in right and left configurations, and eight sizes to accommodate varying anatomy. The Freedom Infinia™ Total Knee System's Cementless Femoral Component is fabricated from Cobalt-Chromium-Molybdenum (CoCrMo) alloy complying with ASTM F75 and porous coated CoCr beads and is intended for cementless biological fixation application to replace the articulating surface of the distal femur in a measured resection.

Freedom Infinia™ Stemmed Femoral Component

The Freedom Infinia™ Total Knee System's Stemmed Femoral Component with progressive constraint (PCK) is fabricated from Cobalt-Chromium-Molybdenum (CoCrMo) alloy complying with ASTM F75, intended for cemented application to replace the articulating surface of the distal femur in a measured resection technique. It is available in left and right configurations. Each configuration is further available in 8 different sizes (A to H) based on Anterior/Posterior (A/P) and Medial/Lateral (M/L) dimensions. Thus total of 16 models are available for the Stemmed Femoral Component.

Freedom Infinia™ Femoral Augments

The Freedom Infinia™ Total Knee System's Femoral Augments are fabricated from Titanium-6Aluminum-4Vanadium (Ti-6A1-4V), complaint with ASTM F136. These augments are intended to be screwed to the internal distal and posterior surfaces of Freedom Infinia™ PCK Stemmed Femoral Component when required in cases of significant bone loss. The augments are designed to be stackable and for use on either the medial or lateral side.
Augment Screws, fabricated from Titanium-6Aluminum-4Vanadium (Ti-6A1-4V), complaint with ASTM F136, are available as an accessory to the system to fix the augments to the Freedom Infinia™ Stemmed Femoral Component and other augments.
The Freedom Infinia™ Femoral Augments is available in distal and posterior design configuration. Each configuration is further available in 6 different sizes.

Freedom Infinia™ Primary PCK Femoral Component

Freedom Infinia™ Total Knee System's Primary PCK Femoral Component is designed to be used with the Freedom Infinia™ Stemmed Tibial Components. It is fabricated from Cobalt- Chromium-Molybdenum (CoCrMo) alloy complying with ASTM F75 and is intended for cemented application.

Freedom Infinia™ Tibial Base Plate

The Freedom Infinia™ Total Knee System's Tibial Base Plate is fabricated from Cobalt- Chromium-Molybdenum (CoCrMo) alloy complying with ASTM F75 and is intended for cemented application to replace the articulating surface of the proximal tibia in a measured resection technique. The Tibial Base Plates are available in 8 different sizes (1 to 8) based on Anterior/Posterior (A/P) and Medial/Lateral (M/L) dimensions.

Freedom Infinia™ Titanium Tibial Base Plate

The Freedom Infinia™ Total Knee System's Titanium Tibial Base Plate is fabricated from Wrought Titanium alloy Ti-6Al-4V ELI, compliant with ASTM F136-13 and is intended for cemented application to replace the articulating surface of the proximal tibia in a measured resection technique. The Titanium Tibial Base Plates are available in 8 different sizes (1 to 8) based on Anterior/Posterior (A/P) and Medial/Lateral (M/L) dimensions.

Freedom Infinia™ Porous Tibial Base Plate

The Freedom Infinia™ Total Knee System's Porous Tibial Base Plate is intended for use with existing, compatible Femoral Components and Tibial Liner Components. Freedom Infinia™ Porous Tibial Base Plates are additively manufactured from Ti-6Al-4V ELI Grade 23 and include a porous lattice structure on the distal face. Freedom Infinia™ Porous Tibial Base Plates are available in eight asymmetric design offerings (Sizes 1 – 8, Left / Right configurations), based on anterior / posterior (A/P) and medial / lateral (M/L) dimensions.

Freedom Infinia™ Stemmed Tibial Base Plate

The Freedom Infinia™ Total Knee System's Stemmed Tibial Base Plate is fabricated from Cobalt-Chromium-Molybdenum (CoCrMo) alloy complying with ASTM F75 and is intended for cemented application to replace the articulating surface of the proximal tibia in a measured resection technique. The Stemmed Tibial Base Plates are available in 8 different sizes (1 to 8) based on Anterior/Posterior (A/P) and Medial/Lateral (M/L) dimensions and are supplied with UHMWPE plugs to close off augment screw holes and distal taper when not used and with a set screw to provide additional locking to the stem or offset junction during extraction.

Freedom Infinia™ Tibial Augments

The Freedom Infinia™ Total Knee System's Tibial Augments are fabricated from Titanium-Aluminum-Vanadium (Ti-6A1-4V), complaint with ASTM F136. These augments are intended to be screwed to the distal surface Freedom Infinia™ Stemmed Tibial Base Plate when required in cases of significant bone loss. The augments are designed to be stackable, using a system of pins, bosses and screws, and reversible for use on either the medial or lateral side. Augment Screws, fabricated from Titanium-6Aluminum-4Vanadium (Ti-6A1-4V), complaint with ASTM F136, are available as an accessory to the system to fix the augments to the Stemmed Tibial Base Plate and other augments.

Freedom Infinia™ Stem Extension

The Freedom Infinia™ Total Knee System's Stem Extensions are fabricated from Titanium-Aluminum-Vanadium (Ti-6A1-4V), complaint with ASTM F136. The Freedom Infinia™ Stem Extensions are intended for use with Freedom Infinia™ Stemmed Tibial Base Plate. The Freedom Infinia™ Stem Extensions are available in a range of diameters and lengths and are fluted distally with a distal slot in the larger lengths and diameters.

Freedom Infinia™ Offset Junction

The Freedom Infinia™ Total Knee System's Offset Junctions are fabricated from Titanium-Aluminum-Vanadium (Ti-6A1-4V), complaint with ASTM F136, are intended to be used with the Freedom Infinia™ Stemmed Tibial Base Plate to provide an additional 4mm or 6mm offset between the tibial keel and stem. Freedom Infinia™ The Offset Junction is attached to the tibial component and stem through taper junctions. A set-screw is supplied with the Offset Junction to provide additional locking during extraction.

Freedom Infinia™ Tibial Liner

The Freedom Infinia™ Total Knee System's Tibial Liner is available in two designs i.e. posterior stabilizing (PS) and cruciate retaining (CR). Based on the Tibial Liner compatibility with Femoral Component configurations, each PS and CR designs are available various sizes with different anterior/posterior (A/P) and medial/lateral (L/P) dimensions, and each size is further bifurcated as on thickness. Tibial liner is fabricated from Ultra High Molecular Weight Polyethylene (UHMWPE) complying with ASTM F648 and is intended for cemented application along Tibial Base Plate to replace the articulating surface of the proximal tibia in a measured resection. Both the CR and PS Tibial Liners have identical locking mechanisms to mate with the Tibial Base Plate.

Freedom Infinia™ Medial Congruent Liner

The Freedom Infinia™ Total Knee System's Medial Congruent Liners have been developed with the desire to achieve a higher level of constraint than typically achieved in a traditional CR knee design while also providing the femoral component with a medial-pivoting motion throughout a range of motion. They possess an anterior and buildup and a higher sagittal conformity of the medial compartment that interact with the femoral component, to provide additional constraint. Designed to be used with the CR Femoral Component. Eliminates the need to remove bone for a PS box. Designed to allow high flexion. Includes a deep anterior patellar cut- out to allow for tendon clearance. Facilitates intraoperative flexibility, given compatibility with existing femoral and tibial baseplate options.

Freedom Infinia™ Ultra-Congruent CR Tibial Liner

The Freedom Infinia™ Total Knee System's Ultra-Congruent CR Tibial Liner consists of an ultra-high molecular weight polyethylene (UHMWPE) liner complies with ASTM F648 that is designed to be used with the Freedom Infinia™ Total Knee Cruciate Retaining (CR) Femoral Components in the Freedom Infinia™ Total Knee System.

Freedom Infinia™ PCK Tibial Liner

The Freedom Infinia™ Total Knee System's PCK Tibial Liner is fabricated from Ultra High Molecular Weight Polyethylene (UHMWPE) complies with ASTM F648. Based on the Tibial liner compatibility with PCK femoral component configurations, each PCK tibial liner design is available different sizes with different anterior/posterior (A/P) and medial/lateral (L/P) dimensions, and each size is further bifurcated on thickness variants.
The PCK Tibial Liners consist of the same articulating surface of existing Tibial liner components and have a same locking mechanism on the peripheral edge of the distal surface to lock into the Tibial / Stemmed Tibial Base Plate. The PCK tibial liner supplied with a liner securing pin manufactured from Ti-6Al-4V ELI to provide additional locking with stemmed tibial base plate.

Freedom Infinia™ All Poly Tibial Component

The Freedom Infinia™ Total Knee System's All Poly Tibial Component is fabricated from ultra high molecular weight polyethylene (UHMWPE) complying with ASTM F648 and is intended for cemented application to replace the articulating surface of the proximal tibia in a measured resection. Both the Total Knee System CR and PS Tibial Inserts have identical locking mechanisms to mate with the Tibial Base Plate.

Freedom Infinia™ All Poly Patella

The Freedom Infinia™ Total Knee System's All Poly Patella is available in symmetrical single radius design. Based on different diameter and thickness different models are available. All Poly Patella is fabricated from Ultra High Molecular Weight Polyethylene (UHMWPE) complying with ASTM F648.
The symmetric design features a central cement recess, and three pegs on the bone interface surface. The symmetric patellar component is intended for cemented application via an onset resurfacing surgical technique.

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Fine Osteotomy™ is a system intended for open- and closed-wedge osteotomies, treatment of bone and joint deformities, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia.

Fine Osteotomy disposable instrumentation is intended to assist in pre-operative planning and/or in guiding the marking of bone and/or guiding of surgical instruments in non-acute, non-joint replacing osteotomies around the knee.

Fine Osteotomy is a patient-specific device.

The Fine Osteotomy™ System is an orthopedic fixation system used to stabilize bone fragments during corrective osteotomies of the distal femur or proximal tibia. The system supports proper alignment and promotes bone healing through rigid internal fixation.The system includes:Metallic bone plates (femoral and tibial) in open- and closed-wedge configurations.Bone screws compatible with the plates.Reusable surgical instruments for positioning and fixation.The plates and screws are made of titanium alloy Ti-6Al-4V ELI, a biocompatible material widely used in orthopedic implants.

The closed-wedge plates now include an oblong hole to enable controlled axial compression at the osteotomy site. An additional glass-bead-blasted surface finish for the plates has been validated to meet the same smoothness requirement as the existing polished finish.The plates are low-profile, anatomically contoured, and fixed with compatible self-tapping screws. The device functions as a load-sharing internal fixation system to maintain alignment during healing.

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The Fule Spinal Fixation System is a thoracolumbosacral pedicle screw system intended to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments (T1 to S2) as an adjunct to fusion in skeletally mature patients for the following acute and chronic instabilities or deformities: degenerative disc disease (as confirmed by patient history and radiographic studies), spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.

The Fule Spinal Fixation System consists of rods, polyaxial pedicle screws, set screws, and connectors, available in a range of sizes to accommodate different patient anatomies. Components are manufactured from titanium alloy (Ti6Al4V, ASTM F136) in accordance with ISO 5832-3.

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FIBERGRAFT™ BG Putty GPS - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Putty GPS is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space, extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT™ BG Putty GPS must be used with autograft in the posterolateral spine. When used in intervertebral body fusion procedures, FIBERGRAFT™ BG Putty GPS must be used on its own with an intervertebral body fusion device cleared by FDA for use with a bone void filler. FIBERGRAFT™ BG Putty GPS is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

FIBERGRAFT™ BG Putty - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space, extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT™ BG Putty must be used with autograft in the posterolateral spine. When used in intervertebral body fusion procedures, FIBERGRAFT™ BG Putty must be used on its own with an intervertebral body fusion device cleared by FDA for use with a bone void filler. FIBERGRAFT™ BG Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

FIBERGRAFT™ AERIDYAN™ Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ AERIDYAN™ Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT™ AERIDYAN™ Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine. FIBERGRAFT™ AERIDYAN™ Matrix must be hydrated with saline or blood for pelvis and extremity applications.

FIBERGRAFT™ BG Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT™ BG Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.

FIBERGRAFT™ BG Putty GPS is an osteoconductive, resorbable, biocompatible bone graft substitute to be gently packed into defect sites and to be used as non-structural scaffolds. The FIBERGRAFT™ BG putty GPS is made from 45S5 bioactive glass, where the bioactive glass components are mixed with an absorbable/polymeric carrier to form a cohesive material. FIBERGRAFT™ BG Putty GPS is to be provided in a spindle drive syringe and is compatible with the GPS Cannula product.

FIBERGRAFT™ BG Putty is an osteoconductive, resorbable, biocompatible bone graft substitute to be gently packed into defect sites and to be used as non-structural scaffolds. The FIBERGRAFT™ BG putty is made from 45S5 bioactive glass, where the bioactive glass components are mixed with an absorbable/polymeric carrier to form a cohesive material.

FIBERGRAFT™ AERIDYAN™ Matrix product is composed of 45S5 bioactive glass (M-45 granules), boron bioactive glass (MS-B microspheres/Borospheres™) and bovine type I collagen. After hydration with saline, blood or bone marrow aspirate (BMA), the AERIDYAN™ Matrix can be applied directly to the defect site or molded into the desired shape and gently packed into the defect site as a non-setting putty. In posterolateral spine fusion applications, the product is intended to be hydrated with bone marrow aspirate (BMA) and mixed with autograft in a recommended 1:1 ratio. In pelvis and extremity applications, the product must be hydrated with saline or blood.

FIBERGRAFT BG Matrix product is composed of 45S5 bioactive glass components (M-45 granules, MS-45 microspheres) and bovine type I collagen. The BG Matrix after hydration with saline, blood, or bone marrow aspirate (BMA) can be applied to the defect site or can be molded into the desired shape and gently packed into the defect site as a non-setting putty. In the posterolateral spine fusion applications, the product is intended to be hydrated with BMA and mixed with autograft in a 1:1 ratio.

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The Flowflex Plus RSV + Flu A/B + COVID Home Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of respiratory syncytial virus (RSV), influenza A, influenza B, and SARS-CoV-2 protein antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to RSV, influenza, and SARS-CoV-2 can be similar.

This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged six (6) months or older.

All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with RSV, influenza, SARS-CoV-2 or other pathogens.

Individuals who test negative and/or experience continued or worsening symptoms, such as fever, cough and/or shortness of breath should therefore seek follow-up care from their healthcare provider.

Positive results do not rule out co-infection with other respiratory pathogens and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.

The Flowflex Plus RSV + Flu A/B + COVID Home Test is a lateral flow immunoassay.

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The Freedom® Total Knee System is indicated for patients with severe knee pain and the disability due to:

• Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Correction of functional deformities.
• Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy.
• Moderate valgus, varus, or flexion trauma.
• Knee fractures untreatable by other methods.
• Revision surgery where sufficient bone stock and soft tissue integrity are present. (For PCK Components and Primary PCK Components only)

The Freedom® Total Knee System – Titan PCK Components are intended for cemented and single use only.

The Freedom® Total Knee System is comprised of a femoral component, all-poly tibial component, patellar component, tibial base plate and tibial articular surface. The Freedom® Total Knee System's Femoral Component is offered as different versions such as stemmed PCK design, primary PCK, cruciate retaining, posterior stabilizing. The Freedom® Total Knee System's Tibial Base Plate is offered with stemmed design and without stemmed design. The Freedom® Total Knee System was originally cleared under the 510(k) number K082019. Later on, several modifications were made and were cleared under 510(k)s K091280, K192148, K090411, K182574, K131481, K111785, K200912, and K240863 respectively.

This submission seeks the clearance of Titanium Niobium Nitride (TiNbN) coated version of previously cleared Femoral Augment (non-coated version cleared in K131481), Tibial Augments, Stem Extension & Offset Junction (non-coated versions cleared in K111785). The coated versions are now branded as Freedom® Total Knee System – Titan PCK Components.

Below is the description of the coated components.

Freedom® Titan Femoral Augments

The Freedom® Titan Femoral Augments are fabricated from Titanium-6Aluminum-4Vanadium (Ti-6A1-4V), complaint with ASTM F136, and are coated with Titanium Niobium Nitride (TiNbN). These augments are intended to be screwed to the internal distal and posterior surfaces of the previously cleared PCK Stemmed Femoral Component (K131481) and Titan PCK Stemmed Femoral Component (K240863) when required in cases of significant bone loss. The augments are designed to be stackable and for use on either the medial or lateral side.

Augment Screws, fabricated from Titanium-6Aluminum-4Vanadium (Ti-6A1-4V), complaint with ASTM F136, and are coated with Titanium Niobium Nitride (TiNbN), are available as an accessory to the system to fix the augments to the Stemmed Femoral Component and other augments.

The Freedom® Titan Femoral Augments is available in distal and posterior design configuration. Each configuration is further available in 6 different sizes.

Freedom® Titan Tibial Augments

The Freedom® Titan Tibial Augments are fabricated from Titanium-Aluminum-Vanadium (Ti-6A1-4V), complaint with ASTM F136, and are coated with Titanium Niobium Nitride (TiNbN). These augments are intended to be screwed to the distal surface of the previously cleared Stemmed Tibial Base Plate (K111785) & Titan Stemmed Tibial Base Plate (K240863) when required in cases of significant bone loss. The augments are designed to be stackable, using a system of pins, bosses and screws, and reversible for use on either the medial or lateral side.

Augment Screws, fabricated from Titanium-6Aluminum-4Vanadium (Ti-6A1-4V), complaint with ASTM F136, and are coated with Titanium Niobium Nitride (TiNbN), are available as an accessory to the system to fix the augments to the Stemmed Tibial Base Plate and other augments.

Freedom® Titan Offset Junction

The Freedom® Titan Offset Junctions are fabricated from Titanium-Aluminum-Vanadium (Ti-6A1-4V), complaint with ASTM F136, and are coated with Titanium Niobium Nitride (TiNbN). Offset Junctions are intended to be used with the previously cleared Stemmed Tibial Base Plate (K111785) & Titan Stemmed Tibial Base Plate (K240863) to provide an additional 4mm or 6mm offset between the tibial keel and stem. The Offset Junction is attached to the tibial component and stem through taper junctions. A set-screw is supplied with the Offset Junction to provide additional locking during extraction.

Freedom® Titan Stem Extension

The Freedom® Titan Stem Extensions are fabricated from Titanium-Aluminum-Vanadium (Ti-6A1-4V), complaint with ASTM F136, and are coated with Titanium Niobium Nitride (TiNbN). The Titan Stem Extensions are intended for use with the previously cleared Stemmed Tibial Base Plate (K111785) & Titan Stemmed Tibial Base Plate (K240863). The Stem Extensions are available in a range of diameters and lengths and are fluted distally with a distal slot in the larger lengths and diameters.

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