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The Falco Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The Falco Fusion System is designed to stabilize or fuse the sacroiliac (SI) joint, helping to reduce pain and improve mobility in patients suffering from SI joint disruptions or degenerative sacroiliitis. The system includes titanium alloy screws (Ti-6Al-4V ELI, ASTM F-136) in diameters of 11mm and 13mm, with lengths ranging from 35mm to 75mm. Additionally, the system comes with disposable Kirschner wires (316-LVM, ASTM F138) and reusable surgical (Stainless Steel, ASTM F899) instruments, providing a comprehensive solution for sacroiliac joint fusion procedures.

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The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.

The Y-Knotless™ Flex Anchors 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 systems thereby stabilize the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The Y-Knotless™ Flex Anchors may be used in the following orthopedic procedures:

1. Shoulder Labrum
2. MPFL Reconstruction
3. Foot and Ankle
4. Biceps
5. Meniscal Root Repair

The Y-Knotless™ Flex Anchors are a non-absorbable, all-suture, knotless implant, that are supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10-6. The implant anchors are composed of a white flat braided ultra-high molecular weight polyethylene (UHMWPE) suture anchor, a tapered #2 Hi-Fi® repair suture either white/black or green/white/black, and a #2-0 Hi-Fi® shuttle suture, blue and black. The implants are pre-loaded on a disposable driver with sutures cleated to the handle. The anchors require a 1.8 mm pre-drilled bone hole created using Class I, exempt instrumentation.

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The Sacroiliac Joint Truss System is indicated for sacroiliac joint fusion for:

• Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis.
• Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The Sacroiliac Joint Truss System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.

The SJTS is a comprehensive surgical solution for sacroiliac joint fusion procedures. The system consists of an instrument set and a wide range of threaded implants. All screws in the 4Web SJTS are cannulated, fenestrated, and made of medical grade Ti6Al4V alloy. The screws come in two distinct sterile implant offerings: a fully threaded screw with compression threads on the proximal head and a partially threaded lag screw with an accompanying washer. The implant offering includes a choice of three different diameters with a variety of lengths to accommodate the patient's anatomy.

The SJTS is intended for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

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The Aevumed PROTEKT™ Suture Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

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

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

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Hip: Capsular repair, Acetabular Labral Repair

The Aevumed PROTEKT™ Sutures Anchor with HS Fiber™ suture is a suture anchor manufactured from polyetheretherketone (PEEK) material and are preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. The Aevumed PROTEKT™ Suture Anchors is available in diameter size: 6.5 mm. It is offered sterile and is for single use only.

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The Anatomic Lapidus Plates and I-Beam Lapidus Plates are intended for use in stabilization of fresh fractures, revision procedures, osteotomies, joint fusion and reconstruction of small bones and bone fragments of the foot.

The Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates consists of a series of plates of varying sizes, orientations, and lengths. The proposed plates are available in small, medium, and long, and left and right configurations. The proposed plates (I-Beam Lapidus Plates only) include an internal beam. Each plate provides locking screw fixation. The proposed plates are manufactured from titanium alloy conforming to ASTM F136. The proposed plates are sold sterile (gamma) and are single-use. The proposed Anatomic Lapidus Plates are sold as standalone, whereas the I-Beam Lapidus Plates are packaged as a kit with instrumentation.

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The QuadLock™ Fixation System is intended for fixation of suture/tape (soft tissue) to bone during surgical procedures, in skeletally mature pediatric and adult patients for the following indications for use:

• Knee:

• ACL/PCL Repair: using non-absorbable UHMWPE USP #2 sutures or larger, or non-absorbable UHMWPE 1.4mm tapes or larger.
• ACL Reconstruction: using non-absorbable UHMWPE USP #2 sutures or larger, or non-absorbable UHMWPE 1.4mm tapes or larger.

QuadLock™ Fixation System is a medical device designed for fixation of suture and/or tape (soft tissue) to bone during surgical procedures.

QuadLock™ Fixation System is a medical device comprised of an implantable device supplied with specific single-use surgical accessories to facilitate its implantation. The implant component consists of a PEEK Cap and a Titanium Alloy Screw. The Cap component is inserted into a bone tunnel in a press fit manner through which the sutures and/or tape are threaded. The Screw component screws onto the Cap, securing the sutures/tapes in place in ACL/PCL repairs or ACL reconstruction surgery.

QuadLock™ Fixation System is currently available in 3 different sizes: 9 mm, 10mm and 11mm. QuadLock™ Fixation System is supplied sterile, sterilized via Ethylene Oxide.

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The TRILEAP Plating System is indicated for fixation of bones and bone fragments of the foot and ankle in adults and adolescents (aged 12 -21 years) where the growth plates have fused.

The TRILEAP™ Plating System is intended for reduction, temporary fixation, fusion and stabilization of bones. The system consists of a family of implantable devices consisting of 2.0mm, 2.5mm, 3.0mm, 3.5mm and 4.0mm non-contoured and anatomic procedure specific plates, cortical screws, variable angle locking screws, and Jones screws available in various sizes. System implants are manufactured from titanium alloy and intended for single use only.

Instruments that may be used with the TRILEAP™ Plating System include Drill Guides, Drill Bits, Cannulated Reamers, Depth Gauges, Bending Pins, Screwdrivers and other instrumentation for general surgery. General instruments are manufactured from stainless steel, aluminum, silicone and plastic. Dedicated system organizational trays are for use in health care facilities for the purpose of containing and protecting medical devices during transportation and storage.

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The Tyber Medical Trauma Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of bones appropriate for the size of the devices. Screws are intended for single use only. The Tyber Medical Trauma Screws are not for spinal use.

This traditional 510(k) submission adds configurations of the previously cleared Tyber Medical Trauma Screws under K192975 and K153575. The Tyber Medical Trauma Screw is designed to allow compression and fixation between two adjacent bone segments. The screw is available with thread diameters of 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, and 9.0mm. The screw is configured to have either full thread, long thread, or short thread. The multiple thread lengths come in various options which can assist to ensure fit for various bone sizes. General trauma screws are intended for compression and fixation of bone.

This Submission also references Washers and Trays. The Trays are specific to the Tyber Medical Trauma Screws.

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The Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm is intended to be used for suture or tissue fixation in the foot/ankle and hand/wrist. Specific indications for use are listed below:

• Hand/Wrist: Repair of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits and Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty)
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Ligament Repair, Hallux Valgus Reconstruction

The proposed Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm is a knotless, two-component suture anchor consisting of a fully threaded and vented anchor body and a closed eyelet. The anchor and eyelet are manufactured from polyetheretherketone (PEEK Optima per ASTM F2026). The anchor and eyelet are preassembled on a disposable inserter with a suture threader. Arthrex recommends the use of the Arthrex 1.3 mm SutureTape (sold separately) previously cleared within Arthrex SutureTape (K193575). The proposed device is offered sterile, single-use, and is packaged in a single-pack (one per box).

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The ZipToe™ Hammertoe Fusion System is indicated for interphalangeal fusion of the toes.

The ZipToe™ Hammertoe Fusion System is a permanent implant designed for fixation of the proximal interphalangeal joint. The device is composed of a titanium alloy sleeve (ASTM F136) with two internally deployed nitinol claws (ASTM F2063). The implant is available in multiple sizes to accommodate varying patient anatomy. The insertion tool for the implant includes two "ripcords" that are pulled to deploy the implant's claws. The "ricord" is a surgical suture that is connected to the implant's claws through a loop; thus, once the implant in place, the ends of the suture ("ripcords") are pulled to deploy the claws. Once deployed, the claws assist in initial fixation by providing opposing compression into the bone and help minimize implant rotation.

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