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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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The Mini Superhawk Suture Anchors are intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures:

• Shoulder: Rotator Cuff Repair, 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, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy, Digital Tendon Transfers.

• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Vastus Medialis Obliquus Advancement, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure.

• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.

• Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.

• Hip: Capsular Repair, Acetabular Labral Repair.

The Mini Superhawk Suture Anchors are anchor devices comprised of polyether ether ketone (PEEK) material that are designed for the fixation of soft tissue to bone. The subject Mini Superhawk system features one 3.75mm diameter Screw-in (start) suture anchor preloaded on an inserter with a 1.5mm suture tape and one knotless 3.75mm diameter Push-in suture anchor preloaded on an inserter with a suture pull tab. The Push-in anchor also includes an auxiliary #0 suture that holds the anchor in place on the inserter until use and is then discarded. The Mini Superhawk Suture Anchors and inserters are assembled as a kit and provided to the end user sterile via ethylene oxide (EO) sterilization.

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The Eleganz™ IM Threaded Nail System 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. Examples include scaphoid and other carpal fractures, metacarpal and phalangeal fusions, and bunionectomies.

The nails are not intended for interference or soft tissue fixation.

The Eleganz™ IM Threaded Nail System includes nails for bone fixation and a set of instruments used for nail site preparation and delivery. The device is offered in one non-sterile tray that contains the nails, Kirschner wire, bone preparation instrumentation and drivers.

The nails are used to stabilize a fracture, osteotomy site, or joint so that healing and fusion may occur which achieves its intended function.

The nails are made from 316L stainless steel. They range from 11-75 mm in length.

The instrumentation includes a reamer, driver handle, driver bit, depth gauge, countersink, and Kirschner wire. The drills and driver components are cannulated. The driver handle is used with the driver bit to insert the screw as well as with the reamer for hand reaming. The countersink has cutting flutes to ease entry of the nails into the intramedullary canal.

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The iFuse Bedrock Granite Implant 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 compatible pedicle screw systems with 5.5- or 6.0-mm posterior rods made from either titanium alloy or cobalt chrome alloys, the iFuse Bedrock Granite Implant 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 compatible pedicle screw systems with 5.5- or 6.0-mm posterior rods made from either titanium alloy or cobalt chrome alloys, the iFuse Bedrock Granite Implant 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.

Please refer to the additional information section in the Instructions for Use on compatible pedicle screw system rods.

The iFuse Bedrock Granite Navigation instruments are intended to be used with the iFuse Bedrock Granite Implant System and the Medtronic StealthStation System to assist the surgeon in precisely locating anatomical structures in iFuse Bedrock Granite Implant 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 Granite iGPS instruments and iGPS Drill Bits are compatible with Globus ExcelsiusGPS® Instrument Trackers and intended to be used with the iFuse Bedrock Granite Implant System and the Globus ExcelsiusGPS® Robotic Navigation System (including the Globus Excelsius3D® Imaging System), which is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.

Use of the iGPS instruments is limited to use only with the 9.5 mm and 10.5 mm iFuse Bedrock Granite implants.

The iFuse Bedrock Granite® Implant System consists of implants of various lengths and diameters, and associated instruments sets. Instrument sets are provided for both open and minimally invasive approaches. The titanium (Ti-6Al-4V ELI) implant consists of a porous fusion sleeve with threaded length attached to a solid post that has connection and implant placement features of a typical pedicle fixation screw. It is intended to provide sacroiliac joint fusion in the sacral alar iliac (SAI) trajectory (when used with commercially available sacroiliac joint fusion promoting devices), and foundational stabilization when connected to pedicle screw fixation systems in both the SAI and the iliac trajectories. Additionally, iFuse Bedrock Granite can be placed into the S1 pedicle. The device is designed for connection to commercially available pedicle screw systems via Ø5.5 mm or Ø6.0 mm titanium alloy or cobalt chrome alloy spinal fixation rods.

The purpose of this submission is to add an alternative option for the set screw (referred to as the Granite Point Lock Set Screw) used with the iFuse Granite Implant System.

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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 MetaFore Small Screw System is indicated for the fixation of bone fractures and for bone reconstruction in hand and forefoot surgery.

The MetaFore Small Screw System consists of implantable screws, and accessories for use in arthrodesis procedures of the hand and forefoot. The screws consist of 2.0mm solid snap-off, 2.5 and 3.0mm cannulated headless and 3.0 and 4.0mm cannulated beveled available in various overall lengths and thread lengths. The screws are manufactured from titanium alloy (Ti-6Al-4V ELI) and provided sterile-packed. The instruments are manufactured primarily from surgical grade stainless steel and titanium and provided non-sterile.

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