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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.

TRIGEN MAX Tibial Nail System: The TRIGEN MAX Tibial Nail is indicated for stable and unstable fractures that occur in and between the proximal and distal third of the tibia, including the shaft. INTERTAN MAX Hip Fracture Nail System: The INTERTAN MAX Nails are indicated for fractures of the femur including: · Fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, and segmental shaft fracture; subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures; and intracapsular fractures - · Polytrauma and multiple fractures - · Prophylactic nailing of impending pathologic fractures - · Reconstruction following tumor resection and grafting.

The Smith & Nephew TRIGEN MAX Tibial Nail and INTERTAN MAX Hip Fracture Nail systems consist of implant intramedullary nails, screws, nail caps, buttress plate, washers and their corresponding US Class II instrumentation. The TRIGEN MAX Tibial Nail system is designed to address fractures of the tibia and the INTERTAN MAX Hip Fracture Nail system is designed to address fractures of the proximal femur.

The TRIGEN INTERTAN Nails are indicated for fractures of the femur including: - Fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, and segmental shaft fractures; subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures: and intracapsular fractures - · Polytrauma and multiple fractures - · Prophylactic nailing of impending pathologic fractures - · Reconstruction following tumor resection and grafting

The TRIGEN INTERTAN 10S Nail System consists of metallic implants including femur nails, leg screw, compression screw, Subtrochanteric lag screw, locking screw, Set Screw, and nail caps. TRIGEN INTERTAN 10S nail is designed to have a slightly different neck taper from the existing neck design of the predicate TRIGEN INTERTAN 10mm Nail (K040212, SE 02/20/2004). The neck taper of the subject devices has been modified to accommodate the different patient population. The TRIGEN INTERTAN 10S system is intended to provide a solution for treatment of proximal femoral fractures with one nail product. The INTERTAN nail includes two interlocking screws near the proximal end that form a worm gear, which is designed to provide stability for hip fracture cases. The subject TRIGEN INTERTAN 10S nails are made of Titanium-6 Aluminum-4 Vanadium (Ti-6Al-4V). The 10S nails are available in both long and short nails. The "S" stands for shey are the smallest diameter nails offered. Design wise, the small diameter and a change to the subject INTERTAN 10S Nail implants are avallable in the 10mm diameter size, with lengths from 18cm to 46cm in 2cm increments, in both 125° or 130° neck angle versions. The INTERTAN 10S nails are single-use and are Gamma sterilized.

NET BRAND Osteosynthesis Nailing System are provided non-sterile. Tibial Nails are indicated for stabilization of fractures of proximal and distal tibial shaft, open and closed tibial shaft fractures, certain pre and postisthmic fractures, non-unions and malunions. Femoral Nails are indicated for stabilization of femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions. The Elastic Nails are indicated for fixation of diaphyseal fractures of the long bones where the medullary canal is narrow or the flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in paediatric or small statured patients, the flexibility of the elastic intramedullary nailing allows it to be inserted at a point which avoids disruption of the bone growth plate. All Implants are for single use only.

NET BRAND Osteosynthesis Nailing System consists of various shape and sizes of Nails and Screws, Locking Bolts. The NET BRAND Osteosynthesis Nailing System are fabricated from Stainless Steel And Titanium. The system contains several models based on the size of the device and application site such as fixation/reconstruction of Tibia and Femoral bones appropriate for the device. The Nail implants are available in many diameters and lengths. These all are mainly divided into - Tibia Nail - Femoral Nail - Elastic Nail - Corresponding Screws and Locking Bolts for Fixations of These Nails. These implants are supplied non-sterile, the products have to be sterilized prior to use.

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 TRIGEN META-NAIL Antegrade Tibial Nail is indicated for stable and unstable fractures of the proximal and distal third of the tibia, including the shaft.

The TRIGEN META-NAIL Nail Systems is designed to be used for internal fixation of long bones in skeletally mature patients. The Subject TRIGEN META-NAIL Systems include TRIGEN Retrograde Femoral, Supracondylar and Tibial Nails (K051557, 6/30/2005), TRIGEN Meta-Nail Retrograde Femoral and Tibial Nails and TRIGEN META-NAIL Nail Cap Set Screw (K061019, 6/6/2006). The subject Smith & Nephew TRIGEN META-NAIL Systems devices are identical in function, design features, materials, sterilization, manufacturing methods and operational principles to what was previously 510(k) cleared. These labeling updates do not affect the safety and effectiveness of the subject devices when used as labeled. The TRIGEN META Antegrade Tibial Nails and the TRIGEN META Retrograde Femoral Nails are intended for the internal fixation of long bones in skeletally mature patients. The TRIGEN META Antegrade Tibial Nails and the TRIGEN META Retrograde Femoral Nails have a round, cannulated geometry and are composed of biocompatible titanium alloy (Ti-6AI-4V complied to ASTM F1472/ISO 5832-3). The TRIGEN META-NAIL Antegrade Tibial & Retrograde Femoral Nails are provided preassembled with polyethylene sleeves, which are manufactured from ultra-high molecular weight polyethylene (UHMWPE)] conforming to ASTM F648 and ISO 5834-2. The TRIGEN META Antegrade Tibial Retrograde Femoral Nailing System also include nail cap set screws. The META Nail Cap Set Screw is also composed of the same Titanium alloy (TI-6Al-4V) as the nail implants. These implants are design to provide a solution for fracture fixation and are offered in a variety of diameters (8.5-13mm) and lengths (16-50cm). The implants within this system are single-use and are Gamma sterilized.

DePuy Synthes Tibial Nail Advanced System: The Tibial Nail Advanced implants are intended for treatment of fractures in adolescents (12-21) in which the growth plates have fused. Specifically, the implants are indicated for: - · Open and closed proximal and distal tibial fractures - Open and closed tibial shaft fractures - · Tibial malunions and nonunions DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm: DePuy Synthes Locking Screws are used for the static and dynamic interlocking of femoral, humeral and tibial nails.

DePuy Synthes Tibial Nail Advanced System: The DePuy Synthes Tibial Nail Advanced System is a system comprised of intramedullary nails, locking screws, end caps implants, as well as system-specific insertion instruments. The Tibial Nail Advanced System is intended to be used for temporary fixation and stabilization of tibia. This system enables three different surgical approaches for the insertion of the nailing implant in the tibia: suprapatellar. parapatellar, and infrapatellar. The implants are manufactured from titanium alloys and provided in a range of dimensions to match individual patient anatomy. The intramedullary nailing implants are cannulated and can be inserted over a reaming rod. The nailing implants are offered in a range of proximal and distal shaft diameters and lengths to accommodate patient anatomy and surgical need related to the specific fracture patterns and locations. The nails will be manufactured from titanium alloy (Ti-6Al-4V) and polyetherketone (PEEK). DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm: The DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm have a diameter of 5 mm available in lengths ranging from 26 up to 120 mm and a diameter of 4 mm available in lengths ranging from 18 up to 80 mm. These implantable devices are fully threaded at the shaft and are self-tapping. The locking screws feature either a standard screw head or a low-profile screw head. The screws are made from titanium alloy (Ti-6Al-7Nb).

Device Name: Auxein Nailing system Indications for Use (Describe) Device Name: Auxein Nailing System are categorized to the following system: 1. Expert Tibia Nailing System 2. Expert Femoral Nailing System 3. Ga-mma Nailing System 4. AJAX Advance nailing system 5. Elastic Nailing System 6. Humeral Nailing System 7. Retrograde Nailing System INDICATION FOR USE: 1. AUXEIN Brand of Expert Tibia Nailing System- consists of variety of Bone nails and bone screws. Expert Tibia Nail System is intended to stabilize fractures of the proximal and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non- unions. 2. AUXEIN Brand of Expert Femoral Nailing System -is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions. 3. AUXEIN Brand of Gamma Nailing System -The Gamma Nail with Anti -Rotation Screw is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, including non-union, malunion and tumor resections. The Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas, impending pathological fractures, long subtrochanteric fractures, ipsilateral fractures, proximal or distal non-unions, malunions, revision procedures and tumor resections. 4. AUXEIN Brand of AJAX Advance Nailing System, end cap and screws is intended to treat stable and unstable proximal femoral fracture including Pertrochanteric fractures and High sub trochanteric fractures and combination of these fractures. 5. The AUXEIN MEDICAL's Elastic Intramedullary Nail System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the important. This includes upper extremity fractures in all patients and lower extremity fractures in children above the age of 6 years and any patient below 65 kg. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures . 6. AUXEIN Brand of Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures. 7. AUXEIN Brand of Retrograde Nailing System This nails are indicated for simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following turnor resection and grafting; supracondylar fractures; bone lengthening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of long bones being treated.

Auxein Brand of Expert Tibia Nail system consists of various shape and sizes of nails featuring proximal & distal holes, End cap & locking bolts of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 8 mm to 12 mm; the length varies from 255 mm to 375 mm. The screw implants are in corresponding diameter of 4.4 mm & 4.8 mm diameters with lengths varying as per the requirements and minimum length: 18 mm to maximum length 90 mm. Auxein Brand of Expert Femoral Nail system consists of various shape and sizes of nails featuring proximal & distal holes, End cap, locking screw & Anti-rotation screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 9 mm to 13 mm; the length varies from 320 mm to 440 mm. The screw implants are in corresponding diameter of 4.8 mm, 6.4 mm diameters with lengths varying as per the requirements and minimum length: 25 mm to maximum length 130 mm. Auxein Brand of Ga-mma Nailing system consists of various shape and sizes of nails featuring proximal & distal holes, End cap, Inner screw, locking bolts, Antirotation screw & Cephalic screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 9 mm to 13 mm; the length varies from 180 mm to 440 mm. The screw implants are in corresponding diameter of 4.8 mm, 6.4mm & 10.5 mm diameters with lengths varying as per the requirements and minimum length: 26 mm to maximum length 120 mm. Auxein Brand of Humeral Nailing system consists of various shape and sizes of nails featuring proximal & distal holes, End cap, locking bolt, compression screw, and proximal screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 7mm to 9 mm; the length varies from 180 mm to 320 mm. The screw implants are in corresponding diameter of 3.5 mm & 4.5 mm diameters with lengths varying as per the requirements and minimum length: 20 mm to maximum length 70mm. Auxein Brand of AJAX Advance Nailing system consists of various shape and sizes of nails featuring proximal & distal holes, End cap, locking bolts, Cephalic screw, inner screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 9 mm to 12 mm; the length varies from 170 mmto 420 mm. The screw implants are in corresponding diameter of 4.9 mm & 10.5 mm diameters with lengths varying as per the requirements and minimum length: 26 mm to maximum length 120 mm. Auxein Brand of Elastic Nailing system consists of various shape and sizes of nails featuring end cap of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 1.5 mm to 4.0 mm; the total length of 440 mm. The end caps are in corresponding diameter ranges from 1.5 mm to 4.0 mm diameters with length of 14 mm & 25 mm. Auxein Brand of Retrograde Nailing system consists of various shape and sizes of nails featuring proximal & distal holes, End cap & locking bolts of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 10 mm to 12 mm; the length varies from 180 mm to 360 mm. The screw implants are in corresponding diameter of 5.0 mm diameters with lengths varying as per the requirements and minimum length: 32 mm to maximum length 80 mm. These implants are sold non-sterile, the products have to be sterilized prior to use.

WIN Flexible Nail System WIN Nails (for use in pediatric patients) are to be used for treatment of long-bone fractures including non-comminuted and comminuted mid-shaft fractures, subtrochanteric fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures. This device is intended for osteosynthesis. The WIN Flexible Nail System is to be used for treatment of long-bone fractures including non-comminuted and comminuted mid-shaft fractures, subtrochanteric fractures, distal third fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures.

The subject WIN Flexible Nail System is made of titanium alloy, which has been continuously made commercially available since the 1950s. This device is to be implanted by insertion into long bones for fixation of fractures.

The Conventus Orthopaedics PHS™ System is indicated for the fixation of proximal humerus fractures except when there are too many fracture fragments to repair the articular surface.

The Conventus PHS™ is an intramedullary device intended to treat proximal humerus fractures. The PHS™ System is a self-expanding implant which is deployed into the medullary canal and provides a scaffold to which bone fragments are attached using fragment screws. The implant is made from titanium alloy (Ti-6Al-4V ELI) and Nitinol.

The China Nails are indicated for simple long bone fractures; severely comminuted, spiral, long oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening; subtrochanteric fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; and intracapsular fractures. The Smith & Nephew, Inc. China Nails are for single use only.

Subject devices of this submission are China Nails and Accessories. The implant components included in the system are described in the following table. | China Nails and Accessories | Diameter | Length | |-----------------------------|--------------|-------------| | Intramedullary Nails | | | | Universal Nails | 9, 10, 11 mm | 17 cm | | Right and Left Hand Nails | 9, 10, 11 mm | 26 - 46 cm | | Screws | | | | Lag Screws | 8.6 mm | 70 - 125 mm | | Compression Screws | 6.2 mm | 65 - 120 mm | | Nail Cap Set Screws | 6.6 mm | 0, 5, 10 mm | | Distal Locking Screw | 4.5 mm | 20 - 65 mm | | | 5.0 mm | 20 - 110 mm | The implants are manufactured from titanium alloy (Ti-6Al-4V).