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The OptumSI Implant System is intended for sacroiliac fusion for the following conditions:

• Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
• To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
• Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

The OptumSI Implant System consists of a cannulated diamond-shape, titanium implant (Ti-6Al-4V ELI, ASTM 3001) with a porous surface. The implant is available in varying lengths and are provided sterile and individually packaged. The system utilizes a transverse approach with a lateral or lateral-to-medial trajectory from the ilium to the sacrum. Instruments are provided as a reprocessable set to assist with gaining access and delivering the implant as intended. The principle operation is based on the diamond-shape and porous surface which are designed to prevent and minimize motion of the sacroiliac (SI) joint, thereby stabilizing the joint or fracture. The mechanism of action is that the interference fit allows for fixation, stabilization, and fusion.

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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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The Skeletal Dynamics Geminus Volar Distal Radius Plating System is intended for fixation of fractures and osteotomies of the distal radius.

The current Geminus Volar Distal Radius Plating System includes medical grade titanium alloy (Ti 6Al-V4 ELI) bone plates offered in 12 sizes, an ulnar hook plate, Cobalt-Chromium-Molybdenum (CoCrMo) and titanium alloy (Ti 6Al-V4 ELI) bone screws and pegs, and specialized instrumentation for the repair of distal radius and osteotomies. The system also includes the Radial Hook Plate extensions to buttress a volar marginal fragment, and the Buttress Button assembly to capture and hold small dorsal corner fractures.

The implants and instruments are provided non-sterile and shall be sterilized at the health care facility.

The Geminus Volar Distal Radius Plating System is comprised of:

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The Pace Surgical Ultra™ Compression Screw System is intended for the internal fixation and stabilization of arthrodeses, osteotomies, fractures, and nonunions of the foot and ankle. The System is specifically indicated for:

Fractures and Osteotomies

• Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc)
• Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture)
• Talar fractures
• Ankle fractures
• Navicular fractures
• Fractures of the fibula, malleolus, and calcaneus
• Metatarsal and phalangeal osteotomies
• Weil osteotomy
• Calcaneal osteotomy

Fusion resulting from neuropathic osteoarthopathy (Charcot), example:

• Medial and lateral column
• Subtalar, talonavicular, and calcaneocuboid

Arthrodesis and Deformity Correction

• 1st MTP arthrodesis
• Metatarsal deformity correction
• Tarsometatarsal joint arthrodesis
• Naviculocuneiform joint arthrodesis
• Talonavicular arthrodesis
• Subtalar joint arthrodesis
• Triple arthrodesis
• Medial column arthrodesis
• Subtalar joint distraction arthrodesis
• Ankle arthrodesis
• Lateralizing calcaneal osteotomy
• Lateral column lengthening
• Hammertoe

Hallux Valgus Correction

• Fixation of osteotomies (i.e. Akin, Scarf, Chevron)
• Interphalangeal (IP) arthrodesis
• Proximal, midshaft, or distal osteotomy
• Lapidus arthrodesis

The Ultra Compression Screw System is intended for the internal fixation and stabilization of arthrodeses, osteotomies, fractures, and nonunions of the foot and ankle. The system consists of various solid and cannulated screws in diameters ranging from 2-8mm with partial and fully threaded variants. Screws are available in headed and headless variants. Compatible washers are also included in the system. All screws and washers are manufactured from titanium alloy per ASTM F136.

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The GMReis Suture Anchors is intended to be used for soft tissue reattachment in the elbow, shoulder, hand, wrist, foot, ankle, knee, and hip. 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, 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, 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: Capsular repair, acetabular labral repair.

The Suture Anchors, manufactured by GM dos Reis Industria e Comercio Ltda, are anchor-type implants, and are manufactured in PEEK (polyetheretherketone). The anchors are made available preloaded in a disposable inserter device, composed of a metal rod and a polymeric handle. The implant and disposable inserter devices are unique products and cannot be sold separately. Implants of the Suture Anchors are classified as surgically invasive, non-absorbable, and non-active implantable medical devices. In addition, the implants, as well as the inserter device, are for single-use and sold in sterile form by Ethylene Oxide.

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The Meduloc Intramedullary Fracture Fixation (IFF) System is intended for use in the fixation of long bone fractures in both adult and pediatric applications.

The Meduloc Intramedullary Fracture Fixation (IFF) System is intended to treat small, long-bone fractures. It consists of three implants: Intramedullary Wire, Bone Anchor, and Locking Screw. The implants are provided in various sizes to accommodate varying patient anatomy. The system also contains a set of ancillary instruments. All elements of the System are Gamma sterilized and provided sterile-packed and are single-use.

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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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The SIros-X System is intended for sacroiliac joint fusion in skeletally mature patients for the following conditions:
• Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
• To augment immobilization and stabilization of the sacroiliac joint in patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
• Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

When connected to the TiLock2 Spinal System, the SIros-X System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:
• Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
• Spondylolisthesis
• Trauma (i.e., fracture or dislocation)
• Spinal stenosis
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Spinal tumor
• Pseudarthrosis
• Failed previous fusion

When connected to the TiLock2 Spinal System, the SIros-X System is intended to provide immobilization and stabilization of spinal segments in skeletally immature patients as an adjunct to thoracolumbar fusion for the treatment of progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis, as well as the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The SIros-X Navigation instruments are intended to be used with the SIros-X System to assist the surgeon in precisely locating anatomical structures in SIros-X System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data-based model of the anatomy. The SIros-X Navigation instruments are intended to be used with the Medtronic StealthStation System.

The SIros-X System is comprised of cannulated screws of various lengths, diameters, and configurations as well as system specific instruments. Instruments are offered to support open and minimally invasive placement of the SIros-X screws.

The SIros-X System is intended to provide fusion of the sacroiliac joint when multiple SIros-X screws traverse the SI joint. In addition, screws with tulips are intended to provide fixation to the pelvis when used with multi-level pedicle screw constructs that terminate in the lumbosacral spine.

The SIros-X System navigation instruments are offered to assist the surgeon in precisely locating anatomical structures in SIros-X System procedures in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data-based model of the anatomy.

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The Aevumed FASE™ 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 FASE™ 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 FASE™ Suture Anchors are available in diameter sizes: 4.75mm and 5.5mm. They are offered sterile and are for single use only.

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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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