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The SF Push-in Anchor is intended to be used for suture or tissue fixation in the foot, ankle, hand, wrist, elbow, knee, hip and shoulder. The SF Push-in Anchor is designed only to be inserted with the SupraFuser® Generator.

SF Push-in Anchor 1.6mm:
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, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
Elbow: Ulnar or Radial Collateral Ligament Reconstruction,
Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction,
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction,
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair.

SF Push-in Anchor 2.3mm:
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, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Triangular Fibrocartilage Complex (TFCC)
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collament Ligament Reconstruction, Lateral epicondylitis repair,
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction,
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, Achilles Tendon Repair, Bunionectomy,
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis,
Hip: Acetabular labral repair, capsular repair.

SF Push-in Anchor 3.0mm and 3.6mm:
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, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Triangular Fibrocartilage Complex (TFCC)
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, lateral epicondylitis repair,
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction,
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus and Varus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, Metatarsal tendon repair, Bunionectomy,
Knee: Medial collateral ligament repair, lateral collateral ligament repair, patellar tendon repair, posterior oblique ligament repair, and iliotibial band tenodesis,
Hip: Acetabular labral repair, capsular repair.

The SF Push-in Anchor system consists of implantable anchors with 1.6, 2.3, 3.0 and 3.6mm diameter, an ultrasonic system, a sonotrode, dedicated anchor size specific drills and stoppers, a handpiece front cover, a guide with integrated wrench, and a set of reamers. The SF Push-in Anchors are delivered in a dedicated Implant Case to facilitate suture loading and suture handling during implantation. The SF Push-in Anchors are made of biocompatible and fully bioresorbable Poly-L-lactide-co-D,L-lactide. The SF Push-in Anchors are fully bioresorbable implants designed for soft tissue reattachment to bone by means of suture materials. The implantation process employs ultrasonic energy to liquefy the polymeric components of the Push-in Anchors at the interface with bone tissue. The liquid polymer flows into the marrow space of the surrounding cancellous bone, where it is immediately quenched and provides anchorage of the implant. The ultrasonic energy for the implantation of the Push-in Anchors is produced by the SupraFuser® ultrasonic generator and applied via the attached handpiece. The sonotrode is mounted on the handpiece. It transmits the ultrasonic vibrations to the Push-in Anchor. The drills and the stoppers are dedicated to be used with the Push-in Anchor of the respective size. The Geomax Reamer is used for the SF Push-in Anchors 1.6, 2.3 and 3.0 in cases of thick cortical bone or oblique insertion.

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LOQTEQ® VA Proximal Humerus Plate 3.5 is indicated for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly in osteopenic bone.

The subject device LOQTEQ® VA Proximal Humerus Short Plates are 21.5 mm wide at the proximal end, 12.4 mm wide along the shaft, and 3.2 mm thick. The shaft of each of the subject device short plates has one (1) oblong, non-locking screw hole, and 2, 3, 4, 5, or 6 VA (variable angle) locking 3.5 mm screw holes.

The subject device LOQTEQ® VA Proximal Humerus Long Plates are 21.5 mm wide at the proximal end, 12.8 mm wide along the shaft, and 3.9 mm thick. The shaft of each of the subject device long plates has one (1) oblong, non-locking screw hole, one (1) VA 3.5 mm screw hole, and 6, 8, 10, 12, or 14 LOQTEQ® 3.5 mm gliding locking-compression screw holes.

The subject device LOQTEQ® Cortical Screws have a standard cortical thread, 3.5 mm in diameter that tapers slightly at the tip. The heads of the screws are threaded to lock into the VA variable angle holes in the subject device plates. The screws are provided in overall lengths of 20 mm to 60 mm, in 2 mm increments.

The subject device LOQTEQ® Cancellous Screws have a standard cancellous thread, 4.0 mm thread diameter that tapers slightly at the tip. The heads of the screws are threaded to lock into the VA variable angle holes in the subject device plates. The screws are provided in overall lengths of 20 mm to 60 mm, in 2 mm increments.

The subject device plates and screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and ISO 5832-3.

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The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) 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, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
• 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, Joint Capsule Closure
• Hip: Capsular Repair, Acetabular Labral Repair and Reconstruction, Gluteal Tendon Repair

The 1.8 Knotless FiberTak® Soft Anchor with #2 Suture is also intended to be used for osteochondral fixation and fractures, including surgeries with autograft and allograft tissues, in the Knee and Hip.

The Arthrex FiberTak Suture Anchors are "all-suture" soft-tissue fixation devices with a push-in design. The anchor (sheath) and connected sutures are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE) and/or Polyester. The subject anchors are impacted into a pilot hole via their inserter. The suture is then manually tensioned to set the anchor by "bulging/bunching" the suture sheath within the pilot hole. The subject devices are provided sterile (Ethylene Oxide), are single-use, and are packaged in a dual-barrier configuration.

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The DynaNail Mini and DynaNail Hybrid System are indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of short bones, long bones, small fragments or large fragments in the foot and ankle.

The DynaNail Helix is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device such as short bones, long bones, and small or large fragments in the foot and ankle.

The DynaClip, DynaClip Forte, DynaClip Delta, DynaClip Quattro Bone Staples are indicated for

• Fracture, osteotomy fixation and joint arthrodesis of the hand and foot.
• Fixation of proximal tibial metaphysis osteotomy.
• Fixation of small fragments of bone (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula, and tibia in the lower extremities; the humerus, ulna, or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula, and sternum.

The DynaNail Mini® Fusion System consists of the following components:

• Fusion Nail
  • DynaNail Mini® Fusion Nail
  • DynaNail Hybrid™ Fusion Nail
• End Cap
• Screws

The DynaNail Mini Fusion System is implanted using the DynaNail Mini Deployment Frame and Ancillary Surgical Instruments. The Fusion Nail is manufactured from nitinol and titanium alloy (Ti6Al- 4V ELI) and is available in multiple diameters and lengths. The End Cap is manufactured from titanium alloy (Ti 6Al-4V ELI). The Screws are manufactured from titanium alloy (Ti 6Al-4V ELI) and are available in a range of lengths.

The DynaNail Helix® Fixation System consists of the following components:

• DynaNail Helix Threaded Bone Fastener
• DynaNail Helix Washer

The DynaNail Helix Fixation System is implanted using the Ancillary Surgical Instruments. The DynaNail Helix Threaded Bone Fastener is manufactured from nickel titanium alloy and titanium alloy (Ti6Al-4V ELI) and is available in multiple lengths. The DynaNail Helix Washer is manufactured from titanium alloy (Ti6Al- 4V ELI).

The DynaClip®, DynaClip Forte®, DynaClip Delta®, DynaClip Quattro® Bone Staples are intended for internal fixation of small bones. The DynaClip Implant and Inserter comprise the DynaClip Device System. The DynaClip Implant is available in several different sizes and leg configurations.

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The Grappler Suture Anchor PCFD Tether System is intended for the fixation of soft tissue to bone including:

Foot/Ankle: Medial Stabilization (Deltoid and Spring Ligament Repair for addressing Progressive Collapsing Foot Deformity), Hindfoot Repair (Correction of Peritalar Subluxation/Dislocation, Hindfoot Valgus Deformity or Subfibular Impingement for Addressing Progressive Collapsing Foot Deformity), Interosseous Talocalcaneal Ligament Repair to address Progressive Collapsing Flatfoot Deformity

The Grappler Suture Anchor PCFD Tether System consists of suture anchors, suture, and the accompanying instrumentation for the intended use of soft tissue damage repair. The subject PCFD Tether line extension consists of two PEEK suture anchors connected by UHMWPE suture. The talar anchor diameter is ⌀4.5mm and the calcaneal anchor diameter is ⌀3.5mm, the length of each anchor is 12mm. The suture tape is a doubled-over USP 2 equivalent tape. The implant construct comes pre-loaded on two inserter handles. Device specific drill guides are provided for tunnel creation.

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The Super Upper Limbs Versalock Plating System is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand, wrist and forearm. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.

The Super Upper Limbs Versalock Plating System consists of plates and screws in a variety of designs and sizes that are commonly used in trauma and reconstructive surgery. The bone plates and screws are made from commercial titanium alloy and pure titanium. The plates range in thickness from 0.6 to 4.0 mm, and the screws range in diameter from 2.0 to 3.5 mm.

Super Upper Limbs Versalock Plating System implants are manufactured with the following raw materials:

• Titanium Alloy Ti6Al4V according to ASTM F136
• Pure Titanium according to ASTM F67

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The SINEFIX is intended for fixation of soft tissue to bone. The SINEFIX is intended for the following indications:

• Shoulder: Rotator Cuff Repairs, Deltoid Repair.
• Foot/Ankle: Achilles Tendon Repair.
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair. Patellar Tendon Repair, Quadriceps Tendon Rupture Repair.
• Elbow: Biceps Tendon Reattachment. Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
• Hip: Gluteus Medius repair, Gluteus Minimus repair.

The SINEFIX is a PEEK implant which can be used to fixate soft tissue to bone. The implant can be used to re-attach complete or partially ruptured soft tissue to facilitate the healing of the natural bone-soft tissue interface. The implant consists of a baseplate with a lateral and a medial anchor. The baseplate is placed over the soft tissue and attached to the bone with the anchors. The medial anchor goes through the soft tissue, while the lateral anchor goes directly into the bone, lateral of the tendon.

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The Trax EX Anchors are intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:

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, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)

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

The Trax EX Anchors are intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. The anchors are manufactured from 6AL-4V ELI Titanium. The Trax EX Anchor is a 2-component anchor compromised of the Trax EX Screw-In and the Trax EX Push-In Anchor with diameter sizes ranging from 3.5mm to 5.0mm. The Trax EX Screw-In Anchor is a hollow 6AL-4V ELI titanium anchor that is threaded, preloaded with suture and designed to fixate into bone by way of threaded engagement. The Trax EX Push-In Anchor component is a hollow 6AL-4V ELI titanium anchor that is ribbed, preloaded with suture, and designed to fixate into bone by way of press-fit engagement. Both anchors will be offered in multiple diameters, lengths, and variations in configuration of the distal end of the implant to allow further functional options to the surgeon. The Trax EX Screw-In Anchor is designed to be used alone or in conjunction with the Trax EX Push-In Anchor. The Trax EX Push-In Anchor component is designed to be used only in conjunction with the Trax EX Screw-In Anchor and is not sold separately. The sutures utilized in all implants are high-strength, Ultra High Molecular Weight Polyethylene (UHMWPE). The Trax EX Anchor Delivery Instruments are intended to prepare the site and fixate the anchors. All kits are intended to be sterilized by ethylene oxide (EO) and provided in a blister tray inside of a Tyvek pouch.

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Strut Suture: The Strut Suture is intended to be used for fixation of bone to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in ACL/PCL Repair.

No-Tie Button The No-Tie Button is intended to be used for fixation of bone to bone, intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in ACL/PCL Repair when used with Strut Suture (or equivalent) and soft tissue fixation to bone in the knee for meniscal root repair when used with RootMend MRR (or equivalent).

Strut Suture devices are a suture and button construct composed of uncoated UHMWPE (ultra-high molecular weight polyethylene) with UHMWPE tracer material and an attachable fixation anchor composed of a titanium (Ti-6Al-4V) button. Strut Suture devices will be provided sterile using ethylene oxide, for single use only, and are not to be re-sterilized.

No-Tie Button devices are an attachable fixation anchor composed of a titanium (Ti-6Al-4V) button. No-Tie Button devices will be provided sterile using ethylene oxide, for single use only, and are not to be re-sterilized.

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The implants of the Xpert Hand range are indicated for the fixation of hand fractures, osteotomies and arthrodeses in adults.

The Xpert Hand range consists of plates and screws designed for the fixation of hand fractures, osteotomies and arthrodeses in adults.

The plates and screws of the Xpert Hand range will be provided sterile by gamma sterilization or non-sterile for sterilization by health care professionals prior to use.

The instruments of the Xpert Hand range will be provided non sterile for sterilization by health care professionals prior to use.

Materials: CP Titanium grade 4 (conform to ASTM F67 and ISO 5832-2) for the plates, and Titanium alloy Ti-6Al-4V ELI (conform to ASTM F136 and ISO 5832-3) for the screws.

Function: The implants of the Xpert Hand range are indicated for the fixation of hand fractures, osteotomies and arthrodeses in adults.

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