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Intended Use: Plate and screw Implants are intended for temporary fixation, correction or stabilization of bones in various anatomical regions. One-Quarter Tubular Plates 2.4/2.7 are indicated for fixation of fractures of the foot, hand, wrist, and forearm (including radius). The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression. Straight Plates 2.4/2.7 are indicated for fixation of fractures, osteotomies, malunions and nonunions of the foot, hand, wrist, and forearm (including radius) and arthrodesis of small bones of the foot and hand. Reconstruction Plates 2.4/2.7 are indicated for fixation of fractures of the foot, hand, wrist, and forearm (including radius) Radius Distal Styloid Plate 2.4/2.7 is indicated for the fixation for fractures of the radial styloid that have metaphyseal comminution or as an adjunct to either volar of dorsal plate fixation when additional support of the radial styloid is required. The Radius Proximal head plates 2.4/2.7 are indicated for extra-articular and intra-articular fractures of the proximal radius and multifragmented radial neck fractures. The Radius Distal Volar Plates 2.4/2.7 are indicated for the fixation for fractures, fusions, or osteotomies of the distal radius. One-Third Tubular Plates 3.5 are indicated for fixation of fractures of the elbow (distal humerus and ulna), and fibula. The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression. Reconstruction Plates 3.5 are indicated for fixation of fractures of the elbow (distal humerus and ulna), wrist, and forearm (including radius), fibula, and calcaneus Straight Plates 3.5 are indicated for fixation of fractures, osteotomies, malunions and nonunions of the elbow (distal humerus and ulna), wrist, forearm (including radius), and fibula. Tibia T-Plates 3.5 are indicated for buttressing of partial articular fractures and bone fragments of the distal tibia. The Clavicle Superior Plates 3.5 are indicated for: - Fractures of the clavicle shaft - Fractures of the lateral clavicle - Malunions of the clavicle - Non-unions of the clavicle The Clavicle Hook Plate 3.5 is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint. The Humerus Proximal Plates 3.5 are indicated for the fixation of fractures, fracture dislocations, non-unions and osteotomies of the proximal humerus. The Tibia Proximal Lateral Plates 3.5 are indicated for: - Split-type fractures of the lateral tibial plateau - Lateral split fractures with associated depressions - Pure central depression fractures - Split or depression fractures of the medial plateau The Tibia Distal Medial Plates 3.5 are indicated for the fixation of fractures, osteotomies, and non-unions of the distal tibia. The Tibia Distal Anterolateral Plates 3.5 are indicated for the fixation of fractures, osteotomies, and non-unions of the distal tibia. The Humerus Distal Dorsolateral Plates 2.7/3.5 are indicated for - Intraarticular fractures of the distal humerus - Supracondylar fractures of the distal humerus - Non-unions of the distal humerus The Humerus Distal Medial Plates 2.7/3.5 are indicated for - Intraarticular fractures of the distal humerus - Supracondylar fractures of the distal humerus - Non-unions of the distal humerus The Ulna Proximal Olecranon Plates 3.5 are indicated for - Complex extra- and intra-articular olecranon fractures - Non-unions of the proximal ulna - Osteotomies - Simple olecranon fractures Broad Curved Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, femur, and tibia. Broad Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, femur, and tibia. Narrow Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, and distal tibia. T Plate 4.5/5.0 is intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression. T-Buttress Plates 4.5/5.0 are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load sharing purposes, e.g., buttressing, tension banding, neutralization, or compression. LL-Buttress Plates 4.5/5.0 are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load sharing purposes, e.g., buttressing, tension banding, neutralization, or compression. Femur Distal Plates 4.5/5.0 are indicated for distal shaft fractures, supracondylar fractures, intraarticular fractures, and periprosthetic fractures of the distal femur Tibia Proximal Lateral Plates 4.5/5.0 are indicated for proximal shaft fractures, metaphyseal fractures, intra-articular fractures and periprosthetic fractures of the proximal tibia.

The Genostis Osteosynthesis System comprises of fracture fixation plates, corresponding screws and required surgical instruments. Different shapes and sizes are available to accommodate for different anatomical regions and locations of fractures. The plate screw interface is either locking, non-locking or, for some plates, realized by a combination hole offering both options (locking and non-locking). All plates and screws are made of titanium alloy (Ti 6Al 4V ELI) according to ASTM F136 and ISO 5832-3. The implants of the Genostis Osteosynthesis System are sterilized by radiation and are delivered sterile.

The Exactech® Equinoxe® Scapula Fracture System is indicated for Open Reduction Internal Fixation (ORIF) procedures of the scapula. Specific clinical indications for ORIF are as follows: Levy Type I, IIA, and IIB fractures, fracture dislocations, osteotomies, and non-unions of the acromion and scapular spine. The 3.5mm diameter and 2.7mm diameter Exactech® EPIC Screws of the Epic Extremity Plate System (cleared under K153340) are also intended for use with the Exactech® Equinoxe® Scapula Fracture System for Open Reduction Internal Fixation procedures of the scapula. The Straight Plates of the EPIC Fracture Plate System (cleared under K172441) are also intended for use with the Exactech® Equinoxe® Scapula Fracture System for Open Reduction Internal Fixation procedures of the scapula.

The Exactech® Equinoxe® Scapula Fracture System with EPIC Screws and Straight Plates is a set of plate and screw components for use in Open Reduction Internal Fixation (ORIF) applications for fractures of the acromion and scapular spine. The Exactech® Equinoxe® Scapula Fracture System includes a range of sizes and options of scapula fracture plates and screws to accommodate varying patient anatomy and needs. Previously cleared components to be used with the Exactech® Equinoxe® Scapula Fracture System include the Exactech® EPIC Locking Screws, EPIC Non-Locking Screws, and EPIC Straight Plates. All components work together in various configurations to address scapular ORIF procedures.

TriMed Ulnar Osteotomy Plates are indicated for use in osteotomy procedures of the Ulna.

TriMed Ulnar Osteosystem System includes plates and screws indicated for osteotomies of the ulna. TriMed Ulnar Osteotomy System plates and screws are manufactured from medical grade stainless steel. Ulnar Osteotomy Compression Plates accept 3.2mm locking and non-locking screws. The lag screw hole in the plate accepts a 3.2mm lag screw that helps achieve additional compression across the osteotomy site.

Intended Use CORIOGRAPH Pre-Op Planning and Modeling Services are intended to provide preoperative planning for surgical procedures based on patient imaging, provided that anatomic landmarks necessary for generating the plan are identifiable on patient imaging scans. Indications for Use The CORIOGRAPH Pre-op Planning and Modeling Services are indicated for use for the following procedures: - Unicondylar Knee Replacement (UKR) - Total Knee Arthroplasty (TKA) - Primary Total Hip Arthroplasty (THA) - Primary Anatomic Total Shoulder Arthroplasty (aTSA) - Primary Reverse Total Shoulder Arthroplasty (rTSA)

Coriograph Pre-Op Planning and Modeling Services (CORIOGRAPH) are Software as a Medical Device (SaMD) that provide pre-operative planning for orthopedic surgical procedures based on patient imaging, surgeon preferences and implant geometry. CORIOGRAPH is comprised of several medical software systems (modules), and these modules share a set of non-medical function software applications called the Case Processing System. CORIOGRAPH is a Software Medical Device System. The medical function modules share a graphic user interface where the surgeon provides their case preferences and patient imaging, retrieves PDF plans generated by the Pre-Op Plan modules, and launches the Modeler modules. #### CORIOGRAPH Pre-Op Plan Modules Using patient-specific information, patient imaging, and surgeon inputs, a pre-operative plan is generated by Smith+Nephew personnel. The plan provides initial alignment recommendations to the surgeon on implant placement based on the geometries of the implant and of the generated bone models. #### CORIOGRAPH Hip Modeler and CORIOGRAPH Shoulder Modeler Modules CORIOGRAPH Hip Modeler and CORIOGRAPH Shoulder Modeler are web-based software applications intended for surgeons to modify the patient-specific pre-operative plan and to evaluate the impact of the modifications through the impingement analysis tools such as Impingement-free Range-of Motion (ROM) and Activities of Daily Living (ADL) simulations.

The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The CONMED Argo Knotless® 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 tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.

The CONMED Argo Knotless® 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 and the suture eyelet are manufactured of PolyEtherEtherKetone (PEEK) material. Each size features a single use driver, a threaded anchor, suture eyelet, a 1.0mm UHMWPE Hi-FiTM, 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. A maximum of six (6) Hi-Fi #2 suture, or 1.3mm Hi-Fi ribbon suture, or (2) two limbs of Hi-Fi tape, or one (1) bioresorbable reinforced implant can be threaded through the eyelet. The repair sutures are then tensioned and cleated on the driver cleat, if deemed necessary by the surgeon. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.

The subject device can be used with the TRIGEN META-TAN Trochanteric Antegrade Nailing System, TRIGEN TAN FAN Trochanteric Antegrade and Femoral Antegrade Nailing System, and the TRIGEN META-NAIL Retrograde Femoral Nail System therefore the indications for use for all three systems are applicable to the subject TRIGEN Stable Lock Nut & Washer. ### TRIGEN META-TAN Trochanteric Antegrade Nailing System The TRIGEN META-TAN Trochanteric Antegrade Nail is indicated for fixation of fractures that occur in and between the proximal third and distal fourth of the femur including simple long bone fractures, severely comminuted, spiral, and segmental fractures, and supracondylar fractures. In addition, TRIGEN META-TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; intertrochanteric fractures; and intracapsular fractures. ### TRIGEN TAN FAN Trochanteric Antegrade and Femoral Antegrade Nailing System Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted spiral, large oblique and segmental fractures; and nonunions. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (e.g. Femoral Antegrade Nail, Trochanteric Antegrade Nail and Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures and intertrochanteric fractures. ### TRIGEN META-NAIL Retrograde Femoral Nail System The TRIGEN META-NAIL Retrograde Femoral Nail is indicated for fractures of the femur including stable and unstable distal metaphyseal fractures, diaphyseal fractures, intra-articular fractures, and peri-prosthetic fractures.

The device in scope of this submission is the TRIGEN Stable Lock Nut & Washer. The TRIGEN Stable Lock Nut & Washer is intended to be used as an aid to normal fracture healing for fractures that occur in and between the proximal third and distal fourth of the femur including simple long bone fractures, severely comminuted, spiral, and segmental fractures, and supracondylar fractures; simple long bone fractures; severely comminuted spiral, large oblique and segmental fractures; nonunions; for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated; and for fractures of the femur that include stable and unstable distal metaphyseal fractures, diaphyseal fractures, intra-articular fractures, and peri-prosthetic fractures. The TRIGEN Stable Lock Nut & Washer is made from Ti-6Al-4V material. The device is Gamma sterilized and intended for single-use only.

The LORRAINE 2.5/3.5mm Distal Humerus System is indicated for intra-articular or extra-articular fractures of the distal humerus, supracondylar fractures, osteotomies, and non-unions. Longer plates may be used for distal humerus fractures with diaphyseal extension.

The Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates, locking and non-locking screws for fixation and corresponding instruments. The plating system is further subdivided into variants/types based on the anatomical location of the fracture. The subject LORRAINE 2.5/3.5mm Distal Humerus System is a variant of the Bonebridge Osteosynthesis Plating System. The plates are primarily manufactured from stainless steel (ISO 5832-1, ASTM F138, or ASTM F139) and include Titanium Inlay Clips (TICs) made from pure titanium (ASTM F67 or ISO 5832-2). The screws are manufactured entirely from stainless steel (ISO 5832-1, ASTM F138, or ASTM F139). All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ASTM F899, ISO 7153-1, ISO 5832-1, and ASTM F138/139), medical grade PEEK, medical grade EPDM terpolymer, or medical grade silicone. All plates are sterilized with gamma irradiation and delivered sterile. Screws and instruments are delivered non-sterile. Devices supplied in a non-sterile condition must be cleaned and steam sterilized prior to surgical use. Non-clinical testing has demonstrated the implants are MR Conditional.

### Montblanc Radius Plate System The Montblanc Radius Plate System is intended for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius and distal ulna. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and malunions. This system can be used for palmar, dorsal or orthogonal application. ### Montblanc Ankle Plate System The Montblanc Ankle Plate System is intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the distal tibia and fibula.

The Montblanc Plate System consists of a series of plates and screws of varying lengths and orientations with Montblanc Radius Plate System and Montblanc Ankle Plate System. Each plate provides locking screw fixation. The proposed plates are manufactured from CP Grade 4 Titanium conforming to ASTM F67. The plates are sold as non-sterile, single-use.

ARIX Pectus Bar System is intended for use in surgical procedures to repair Pectus Excavatum and other anterior chest wall deformities.

ARIX Pectus Bar System is used in a minimally invasive surgical procedure to correct pectus excavatum, a type of deformity of the thoracic wall, characterized by a concave shaped chest. This device consists of pectus bar and stabilizer to lift the sternum upwards to lessen the severity of the deformity. ARIX Pectus Bar System includes appliance accessories used in surgical procedures to insert a fixation bar into the thoracic cavity and get it fixed to the coastal ribs for repairing pectus excavatum, a type of deformity of the thoracic wall. Depending on the method of connection, Pectus Bars are used in combination of three types (Single Bar System, Double Bar System, Multi Bar System). Especially, Single Bar System is used only for the Lower Bar, and the Upper Bar cannot be used alone.

The SIGNEX plates and screws are indicated for the fixation of upper extremity (humerus, olecranon, radius, ulna, metacarpals, phalanges), lower extremity (femur, tibia, fibula, tarsals, metatarsals, phalanges), and clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Hand System is indicated for fixation of hand (metacarpals, phalangeal) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Wrist System is indicated for fixation of wrist (distal radius, ulna) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Forearm System is indicated for fixation of forearm (radius and ulna) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Elbow System is indicated for fixation of elbow (distal humerus, olecranon, proximal radius and ulna) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Humerus System is indicated for fixation of humerus fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Foot System is indicated for fixation of foot (tarsal, metatarsal, phalangeal) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Fibula System is indicated for fixation of fibula fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Tibia System is indicated for fixation of tibia fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Femur System is indicated for fixation of femur fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Clavicle System is indicated for fixation of clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Universal Plates are indicated for fixation of arm (humerus, radius, ulna), leg (femur, tibia, fibula), and clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions.

This product is intended for closure /or bone fixation of fractures, fusion, osteotomies, non-union, malunion and reconstruction of hand, wrist, forearm, elbow, humerus, foot, fibula, tibia, femur and clavicle. This is comprised of plates and screws. The plates are made of Pure Titanium (ASTM F67) or Ti-6Al-4V ELI Titanium alloy (ASTM F136), and screws are made of Ti-6Al-4V ELI Titanium alloy (ASTM F136). The plates and screws are single-use only, non-sterile products. So, those must be sterile before use.