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The HKT Anatomical Locking Trauma System is intended for adult patients for fixation of fractures, osteotomies, and non-unions of the clavicle, humerus, elbow, radius, ulna, hand, tibia and foot.

The HKT Anatomical Locking Trauma System is a collection of implantable bone plates and bone screws. The HKT Anatomical Locking Trauma System is intended for adult patients for fixation of fractures, osteotomies, and non-unions of the clavicle, humerus, elbow, radius, ulna, hand, tibia and foot. This system consists of Bone Plates, Bone Screws and Washers

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The ENOS Software Guided External Fixation System application is used with the Paragon 28 Monkey Rings™ External Fixation System for the treatment of traumatic or reconstructive deformities within the indications for use of the Monkey Rings External Fixation System. It is used to generate a prescription of strut adjustments to provide to the patient.

The ENOS Software Guided External Fixation System (also known as Smart Monkey Rings) is a cloud-based medical device software system that assists orthopedic surgeons in planning patient-specific deformity corrections for use with the Monkey Rings Circular External Fixation System. The surgeon enters anatomical alignment values, hardware configuration parameters, and treatment objectives, and the software's algorithm processes these inputs together with the mechanical characteristics of the Monkey Rings hardware to generate a patient-specific strut adjustment schedule.

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The RIB LINK™ Fixation System is indicated for use in the stabilization, fixation, and reconstruction of rib fractures, fusions, osteotomies, resections, including spanning gaps and/or defects, and chest wall deformities including rib hump deformity. These implants are indicated for use in skeletally mature patients with normal or osteoporotic bone for chest wall fixation.

The RIB LINK™ Fixation System includes a variety of plates, rods, and screws intended for use in rib fixation and stabilization applications. The implants are available in various sizes and styles and can be assembled in multiple construct configurations to accommodate varying patient anatomy. The constructs can be surgically positioned across the external surface of the ribs. RIB LINK™ implants are manufactured from titanium alloy as specified in ASTM F136.

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The OSSIOfiber® Suture Anchors are indicated for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation, 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 and Bunionectomy.
• Knee: Anterior Cruciate Ligament Repair (4.75-5.5 Anchors Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair and Meniscal Root Repair. Secondary or adjunct fixation of ACL/PCL reconstruction or repair (4.75 - 5.5 Anchors only).
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair (Tennis Elbow).

The OSSIOfiber® Suture Anchor consists of an eyelet and anchor body preloaded on an inserter. The anchor body and eyelet are made from poly (L-lactide-co-D,L-lactide) (PLDLA) reinforced with continuous mineral fibers. OSSIOfiber® implants have been shown to be biocompatible. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made from minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the bone. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery. Sutures, needles and suture snare may also be provided with the device depending on configuration.

The OSSIOfiber® Suture Anchors are sterile, single-use, and non-pyrogenic.

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The KLS Martin Ixos system is indicated for use in forearm fractures, osteotomies, and arthrodeses. This system is intended for adults, as well as adolescents (12-21 years) and children (2-12 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

The KLS Martin Ixos System consists of metallic plates used in conjunction with bone screws and locking pins intended for the internal fixation, alignment, stabilization, and reconstruction of the radius and/or ulna. Plates are manufactured from Ti-6Al-4V and are available in various shapes and dimensions. The system also includes the necessary instruments to facilitate placement of the implants. The manufacturing process, sterilization methods, materials and packaging are identical to those of the cleared predicate device, KLS Martin LINOS Wrist System (K222624).

The purpose of this premarket notification is to expand the Ixos system to include anatomically pre-contoured plates designed to conform to the dorsal aspect of the radius, the distal ulna, and the shaft portions of both the radius and ulna. These plates will be available in both left and right configurations. In addition, new sizers will be introduced to the current Ixos system to assist with intraoperative selection and placement.

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The KLS Martin Pure Pectus System is indicated for use in surgical procedures to repair pectus excavatum and other anterior chest wall deformities. It is indicated for use in adult and pediatric (children and adolescents) populations.

The KLS Martin Pure Pectus system consists of metallic implants comprised of straight and angled pectus bars and connector bars that provide support to the thoracic cavity undergoing repair for pectus excavatum and other anterior chest wall deformities. The implants are provided non-sterile in multiple sizes and are manufactured using traditional manufacturing methods. Pectus bars are manufactured from CP Titanium. Connector bars are manufactured from Ti-6Al-4V. The system also includes the necessary instruments to facilitate placement of the implants.

The purpose of this submission is as follows:

1. Line extension to include the Pectus Stabilizer

2. Add "MR Conditional" to the device labeling for the Pectus Stabilizer used in conjunction with pectus bar.

3. Expand the Indications for Use to include other anterior chest wall deformities such as Pectus Carinatum and Pectus Arcuatum

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The ATLAS™ Expandable Osteotomy Wedge System is an expandable osteotomy wedge fusion device used for internal bone fixation for bone fractures, fusions, or osteotomies in the foot and ankle.

The ATLAS™ Expandable Osteotomy Wedge System is intended for use with supplemental fixation for use in the foot or ankle.

The ATLAS™ Expandable Osteotomy Wedge System is not intended for use in the spine.

The ATLAS™ Expandable Osteotomy Wedge System is an expandable osteotomy wedge fusion device used for internal bone fixation for bone fractures, fusions, or osteotomies in the foot and ankle.

The ATLAS™ Expandable Osteotomy Wedge System consists of implants manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F136. Expansion mechanism components are manufactured from Molybdenum-47.5 Rhenium Alloy (MoRe) per ASTM F3273. Instrumentation are manufactured from Stainless Steel per ASTM F899.

The ATLAS™ Expandable Osteotomy Wedge System implants are offered in multiple configurations and different sizes to accommodate various patient anatomical requirements. The implants (osteotomy wedges) will be provided sterile packed and are intended for single use only. The instruments will be provided non-sterile and will be steam sterilized by the end user.

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The Biosteon™ Screw is indicated for use in anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), medial collateral ligament (MCL), lateral collateral ligament (LCL), and medial patellofemoral ligament (MPFL) reconstruction procedures where the surgeon:
• places the graft in tibial and/or femoral tunnels; and
• inserts between the tunnel wall and graft to hold the graft in place

The Biosteon™ Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL, PCL, MCL, LCL, and MPFL reconstruction.

The Bioston™ Screw is used to provide interference fixation during femoral and/or patellar tibial fixation in ACL, PCL, MCL, LCL, and MPFL reconstruction using a soft tissue graft (semi-tendonodesis gracilis).

The Biosteon® Screw is a cannulated, tapered, sterile, single-use interference screw made of an absorbable polymer that will gradually be absorbed into the body. The Biosteon® Screw is manufactured from a mixture of hydroxyapatite (HA) and poly(L-lactide) (PLLA). The device is available in diameters 6mm - 12mm, and lengths 23mm -35mm.

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The Wrist Fracture System Distal Radius Plate is indicated for fixation of fractures, osteotomies, and non-unions of the distal radius.

The Wrist Fracture System Dorsal Bridge Plate is indicated for fixation of fractures, osteotomies, and non-unions of the radius.

The Met One Technologies Wrist Fracture System is an implant system for the repair of radius fractures. Included in the system are titanium fracture plates, titanium bone screws, k-wires, and surgical instrumentation.

Distal radius plates are intended for fixation of fractures, osteotomies and non-unions of the distal radius. Various widths and lengths of distal radius plates are available to accommodate differences in patient anatomy. The dorsal bridge plate is intended for fixation of fractures, osteotomies and non-unions of the radius. One size of dorsal bridge plate is available. All plates are offered in multiple titanium grades and production processes which includes grade 23 titanium (Ti-6Al-4V ELI) per ASTM F 136, grade 4 titanium (CP Ti) per ASTM F67, additively manufactured grade 23 titanium (Ti-6Al-4V ELI) per ASTM F3001, and additively manufactured grade 1 titanium (CP Ti). Each plate is designed with pre-determined hole angles and incorporates a self-locking mechanism to resist movement of the screw relative to the plate.

Screws are available in two diameters (2.4 mm and 3.0 mm) and in a variety of lengths to accommodate differences in patient anatomy. All screws are manufactured from grade 23 titanium (Ti-6Al-4V ELI) per ASTM F136. The 2.4 mm screws are designed to allow a 30° cone of variable angle locking when used with fracture plates. The 3.0 mm screws are intended to be inserted orthogonal to the bone plate in predetermined holes where they self-lock with the fracture plate.

K-wires are available in 1.1 mm diameter and are used for temporary fixation or permanent implantation in specifically designed holes in fracture plates. K-wires are manufactured from 316L stainless steel per ASTM F138 or grade 23 titanium (Ti-6Al-4V ELI) per ASTM F136.

Instruments are provided for the preparation, implantation, and removal of implants. All instruments are reusable.

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The T2 Alpha Femur Retrograde Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved. The indications for use of these internal fixation devices include:

• Open and closed femoral fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures and tumor resections
• Supracondylar fractures, including those with intraarticular extension
• Fractures involving osteopenic and osteoporotic bone
• Fractures distal to a total hip prosthesis
• Periprosthetic fractures
• Nonunions and malunions

The Pangea Femur Reconstruction System is indicated for the internal fixation and stabilization of femur bone fractures and osteotomies in normal and osteopenic bone, including:

• Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures.
• Non-unions, malunions, and deformities.
• Peri-implant fractures.

When used with the T2 Alpha Femur Retrograde Nailing System, the Pangea Femur Reconstruction System is used for the indications of the T2 Alpha Femur Retrograde Nailing System.

T2 Alpha Femur Retrograde Nailing System, previously cleared in K250163, consists of implants (intramedullary nails in various diameter and sizes, compression screw, end caps, distal lateral/medial struts and interlinking dowels), as well as non-sterile instrumentation.

The subject of this 510(k) submission is to introduce new devices of the T2 Alpha Femur Retrograde Nailing System. This line extension consists of shorter lengths of the pre-contoured lateral struts, and of a spanning attachment to be used together with the existing lateral struts.
The struts and spanning attachments are manufactured from Ti6Al4V ELI (Type II anodization) and are available in left/right versions; these will be provided both non-sterile and sterile packaged.

Additionally, the purpose of this bundled submission is to rebrand some of the devices previously cleared in K250163 under the new Pangea Femur Reconstruction System. This system will consist of the distal lateral and medial femur plates, the dowels and the spanning attachments, as well as non-sterile instruments. The anatomically pre-contoured plates and interlinking dowels of this system will be used in combination with the existing nails of the T2 Alpha Femur Retrograde System for the treatment of complex fractures of the distal femur.

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