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Synchfix™ EVT is intended for soft tissue and bone fixation for ankle syndesmosis disruptions with or without ankle fractures and as an adjunct in connection with hardware for ankle fractures such as Weber B, Weber C and Maisonneuve in adult and adolescent patient populations.

The subject device, Synchfix™ EVT, is a sterile, single-use, suture-button system intended to stabilize syndesmotic disruptions in the ankle. The subject system consists of a UHMWPE suture tensioned between two titanium alloy buttons and single use instruments to assist in implantation, including a pre-loaded inserter.

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The Arthrex BioComposite 2.0 mm SutureTak Suture Anchor is intended for suture (soft tissue) fixation to bone in the elbow, shoulder, hand/wrist, foot/ankle, knee, and hip in the following procedures:

• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-Foot Reconstruction
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
• Hip: Acetabular Labral Repair and Reconstruction

The Arthrex PEEK Mini Hip SutureTak is intended to be used for suture (soft tissue) fixation to bone in the hip. Specifically, Acetabular Labral Repair and Reconstruction.

The fundamental technology of the Arthrex SutureTak Suture Anchor is that the Arthrex SutureTak Suture Anchors are "hard-bodied" fixation devices with anchors manufactured from either BioComposite or PEEK material. The subject anchors are preassembled to suture manufactured from UHMWPE and Polyester. The anchor is first impacted into a pilot hole. Once the anchor is set, the suture is passed around the soft tissue and is fixated via its surgical technique. The devices are provided sterile, are single-use, and are packaged in a dual barrier packaging configuration.

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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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Fine TTO™ is a patient-specific system intended for tibial tuberosity osteotomies (TTO) in skeletally mature patients.

The device is intended to assist in pre-operative planning and in guiding surgical instruments during the procedure, and should be used only when the anatomical landmarks required for planning can be clearly identified on the patient's radiographic images.

The Fine TTO™ system is designed specifically for tibial tuberosity osteotomies to adjust the alignment and positioning of the tibia for improved knee mechanics in skeletally mature patients. This system uses advanced imaging techniques, such as X-rays and CT scans, to create precise, patient-specific surgical guides. These guides assist surgeons in accurately cutting and repositioning the tibial tuberosity, ensuring the adjustments closely match the pre-surgical planning.

The primary function of Fine TTO™ is to facilitate precise bone cuts and ensure optimal placement according to the surgical plan, which is tailored to the patient's unique anatomy. The scientific concept behind Fine TTO™ relies on biomechanical principles of bone alignment and load distribution in the knee joint, aiming to restore the natural mechanics.

Device design and materials:

• Cutting Guides: Made from medical-grade polymers that are biocompatible and capable of providing the necessary rigidity and precision for bone cutting operations. These guides are designed for single use to ensure sterility and accuracy.
• Implants (Screws): Made from titanium alloy (Ti-6Al-4V ELI), known for its strength, biocompatibility. This material is standard in orthopedic applications and helps in the fixation process post-osteotomy.

Physical and performance characteristics:

• The system's design ensures that the cutting guides fit precisely to the patient's bone structure, reducing the risk of intraoperative errors and improving the predictability of the surgical outcome.
• The titanium screws used in the system provide strong, durable fixation that can withstand the mechanical forces exerted by the body weight and movement, supporting proper bone healing.

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The SiNAPTIC Osteotomy Wedge System is intended to be used for internal bone fixation for fractures or osteotomies in the ankle and foot, such as:

1. Opening wedge osteotomies of the bones of the foot, including osteotomies for Hallux Valgus
2. Opening wedge of the medial cuneiform or Cotton osteotomies.
3. Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z-Osteotomy)
4. Metatarsal Cuneiform osteotomies
5. Nonunion of arthrodesis of the Midfoot including Metatarsal Cuneiform osteotomies (TMT or Lapidus)
6. Hindfoot osteotomies such as Ankle fusion and Subtalar fusion

The Osteotomy Wedge System MTP Wedges are intended to be used for internal fixation of metatarsal bones that have been surgically prepared (osteotomy) for correction of deformity.

The Osteotomy Wedge System is indicated for use with supplemental fixation.

The Osteotomy Wedge System is not indicated for use in the spine.

The Osteotomy Wedge System devices are a sterile, single use Silicon Nitride (Si₃N₄) implants. The wedges are designed in a variety of shapes, each available in multiple footprints and thickness. The Osteotomy Wedge System is intended to be used for internal bone fixation for opening or lengthening osteotomies in the foot and ankle. The wedges contain an insertion feature as well as a central, open area for packing graft material or insertion of supplemental fixation.

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The BioBrace® Extra-Articular Ligament Augmentation Kit is intended to reattach soft tissue to bone and reinforce soft tissue where weakness exists in extra-articular knee ligament 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 BioBrace® Reinforced BioInductive Implant is intended for reinforcement of soft tissues that are repaired by suture or suture anchors during knee repair surgery including reinforcement of patellar ligament, medial collateral ligament, lateral collateral ligament or other knee extra-articular ligaments. It is not intended to replace normal body structures or provide the full mechanical strength to the repair. 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 BioBrace® Extra-Articular Ligament Augmentation Kit is a single-use augmentation procedure kit for use in general surgical procedures for BioBrace® Reinforced BioInductive Implant ("BioBrace® implant") reinforcement of soft tissue where weakness exists, specifically in the extra-articular knee ligaments.

The kit is comprised of bioabsorbable implants and instrumentation. The kit includes one (1) tapered BioBrace Implant 5x250mm, which is threaded through the anchor eyelet.

Kit components are assembled in a single PETG tray and retainer then sealed in a Tyvek pouch. The BioBrace® Extra-Articular Ligament Augmentation Kit is supplied sterile (ETO).

Identical to K240090
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 10-6. 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.

Identical to K244025
Argo Knotless® GENESYS™ Anchor: The Argo Knotless® GENESYS™ Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10-6. 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.

Identical to K242187
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 extra-articular 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, spring 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.

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The Pediatric Plating Platform | Small-Mini is indicated for internal fracture fixation, osteotomies, mal-unions, and non-unions of bones and bone fragments of the appendicular skeleton appropriate for the implant size. The Pediatric Plating Platform | Small-mini is intended for children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which unfused growth plates will not be compromised by fixation, and adults. If used in the femur, tibia, humerus, patella, or pelvis the Pediatric Plating Platform | Small-Mini can only be used for non-load bearing stabilization and reduction.

The Pediatric Plating Platform | Small-Mini consists of plates and screws in a variety of sizes and shapes to accommodate different anatomic requirements. The Pediatric Plating Platform | Small-Mini also includes surgical instruments.

The Pediatric Plating Platform | Small-Mini offers a selection of implantable devices, consisting of straight and shaped plates, and screws specifically designed for the appendicular skeleton appropriate for the implant size. The plates are offered in a variety of shapes (Reconstruction Plate, Strength Plate, T-Plate, L-Plate, Y-Plate, Triangle Plate, Flare Triangle Plate, Distal Radius Plate, Peri-Implant Plate, Mesh Plate, Tubular Plate, Locking Compression Plate, and Hook Plate) and lengths to accommodate the anatomy for fixation of traumatic fractures or following planned osteotomies. The plate is fixed to the bone via the choice of polyaxially locking and non-locking screws to ensure stable fixation and healing. The Pediatric Plating Platform | Small-Mini is available in 2.0, 2.4, 2.7 and 3.5 families providing a suitable range of screw and plate sizes.

The implants of the Pediatric Plating Platform | Small-Mini are manufactured from implant grade 316LVM Stainless Steel (ASTM F138 and/or F139).

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The Newclip Patient-matched instrumentation non sterile PSI is indicated to be used as a surgical instrument to assist in pre-operative planning and/or in guiding surgical instruments in Distal Tibial Medial Opening or Closing Wedge Osteotomy, Distal Tibial Lateral Closing Osteotomy, when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e., computed tomography (CT)). Each PSI is designed to be compatible with implants from the Newclip Activmotion S DTO Range.

Newclip Patient-matched instrumentation non sterile PSI are patient specific instrument (PSI) guides intended to assist in pre-operative planning and/or in guiding the marking of bone and/or surgical instruments in non-acute, non-joint replacing osteotomies about the knee and distal tibia. The PSI Guides are surgical drilling and cutting instruments that are designed to match the patient's anatomy. The PSI guides are additively manufactured, are single-use devices, and provided clean, nonsterile to the end-user. The purpose of this 510(k) is to obtain FDA clearance for PSI Guides for distal tibial osteotomies and facilitate implantation of Newclip Activmotion S DTO Range devices that were 510(k) cleared by the US FDA.

Material: Polyamide (PA2200).

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The External Fixation Mini Rail System is intended for external fixation and is indicated for stabilization of fractures and osteotomy, foot arthrodesis, adult and pediatric leg lengthening, and correction of bone deformity in the lower extremities. The External Fixation Mini Rail System is intended to be used in pediatric patients that are children aged 2 years to less than 12 years and adolescents aged 12 through 21 years (up to but not including the 22nd birthday).

The External Fixation Mini Rail System consists of pins, rail, wires and pins clamps. The mini rail frame serves as the structural base for fixation distraction. The pin clamps allow rotational and translational positioning of bone segments. The system is meant to offer a solution for compression and gradual distraction of the metatarsals and 1st metatarsophalangeal (MTP) joint. The system also includes instrumentation for implantation such as wires, drivers, sawblades, wrenches, templates and cut guides.

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The Auxano® Wedge Fixation System is intended to be used as internal bone fixation for bone fractures or osteotomies in the ankle and foot. Specific indications include:

• Cotton (opening wedge) osteotomies of the medial cuneiform
• Evans lengthening osteotomies

The Auxano® Wedge Fixation System is indicated for use with ancillary plating fixation.

The Auxano® Wedge Fixation System is not intended for spinal use.

The Auxano® Wedge Fixation System (WFS) is a titanium implant that is designed to be used for internal bone fixation and angular correction of foot geometry. The implants are offered in different length x width profiles (16x11, 20x14, 18x18, 20x20, and 22x22 mm) and heights (4.50, 5.50, 6.50, 8, 10, and 12 mm) to address different anatomic locations and size variations. All implants are made from Ti-6AL-4V ELI Titanium alloy per ASTM F3001. The Auxano® Wedge Fixation System includes implants, the instruments necessary to implant them, and the tray system for transport, storage and sterilization.

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