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This implant is indicated as a temporary implant to aid in the healing of long diaphysis fractures, malunions and nonunions and to prevent further fractures in femur, tibia and humerus in pediatric patients suffering from Osteogenesis Imperfecta without disrupting the bone growth plate. It can be used in procedures such as bone lengthening/shortening concomitantly with external fixators in pediatric or small stature patients with limb length discrepancy.

The Fassier-Duval Telescopic IM System is a telescopic rod for use in fixation of long bone fractures. The design of the nail includes a female component (which is attached to the proximal -trochanteric- cortex of the bone) and a male component (which is attached to the distal cortex of the bone). Anchorage of the components is achieved through screw-type fixation. The nail is composed of two sliding components that allow for extension of its length as the bone structures heal and normal patient growth occurs. The Peqa Medical Fassier-Duval Telescopic IM System can be attached to bony structures without disrupting the bone growth plates. This Special 510(k) Premarket Notification is submitted for the additional offering of gamma sterilized Ø3.2 – Ø6.4 stainless steel Fassier-Duval implant components. All subject components have previously been cleared as non-sterile implants. All other components of the Fassier-Duval Telescopic IM System will remain non-sterile to be sterilized by end-user.

The Simple Locking IntraMedullary (SLIM) System is intended as a temporary implant for alignment, stabilization and fixation of long bones that have been surgically prepared (osteotomy) for correction of deformities, or have sustained fractures due to trauma or disease. This includes: - Femur and tibia in the pediation (child and adolescent), and small-stature adults such as patient with small intramedullary canals affected by skeletal dysplasias, osteogenesis imperfecta or other bone diseases. . Humerus, ulna, fibula in all patient populations

The Simple Locking Intra-Medullary (SLM) system consists of intramedullary fixation devices for use in long bones. The solid shaft, bevelled point, and pre-determined or blank length options is designed for easy insertion in the medullar canal. Anchorage of the device is achieved through a conical thread to obtain a stable fixation in the epiphyses or cortical bone, which aims to reduce the risk of migration. Internal features, such as a hexagonal drive and an internal mechanical thread in the device, are designed for capture and guidance during insertion and retrieval. Additional proximal and distal locking holes allow pinning to ensure fixation with locking pegs when required, and the Bullet screws allow fixation of smaller diameter shafts that cannot be cross-pinned due to their size. The SLIM implants are manufactured in medical grade Stainless Steel (SS316L, ASTM F138). The rods are available in seven diameters: 2.0.2.6.3.2. 4.0. 4.8. 5.6 and 6.4 mm, from 80mm up to 400 mm in length allows end user to customize the length of the rod.

The Locking Pediatric Osteotomy Plate (LolliPOP) system is a modular hip blade-plate system intended for stable fixation of valgus, varus, derotation, flexion and extension of proximal femoral osteotomies (PFO) and fractures in the pediatric (ages 2 to 21 years old) population. Indications for use include the following: *Inter and subtrochanteric valgus osteotomies *Inter and subtrochanteric varus osteotomies *Inter and subtrochanteric derotation osteotomies *Inter and subtrochanteric flexion and extension osteotomies, *Inter and subtrochanteric fractures.

The Locking Pediatric Osteotomy Plate (LolliPOP) system is a modular hip blade-plate system intended for stable fixation of valgus, varus, derotation, flexion and extension, of proximal femoral osteotomies (PFO) and fractures in the pediatic population. PFOs are widely performed reconstructive surgeries in children with hip deformities, such as Coxa Valga, Coxa Vara and other congenital deformities. The implants are made of medical grade 316L Stainless Steel (ASTM F138) and are offered in four sizes: infant, child, adolescent and adolescent HD. The system is comprised of a set of plates, connectors, locking cortical screws, polyaxial compressions screws, and all the instrumentation required for implantation and retrieval of the device.

The Y3 Proximal Femoral Plate System is intended for the temporary internal fixation of fractures and osteotomies of the greater trochanter or of the proximal femur. It is indicated for the following: - Re-attachment of the greater trochanter following osteotomy in THA - Trochanteric and intertrochanteric fractures - Extended trochanteric osteotomy - Periprosthetic femoral fractures - Comminuted fractures - Mal-unions and non-unions - Fractures in osteopenic bone

The Y3 Proximal Femoral Plate System is an innovative fixation device intended for the treatment of proximal femoral fractures and osteotomies. The unique Y-shape design divides the proximal portion of the plate into anterior and posterolateral branches, thus intended for stability at the Greater Trochanter level both in rotation and translation while reducing the prominence of the implant. Fixation options include locking and non-locking screws in addition to cerclage cables. The Y3 Proximal Femoral Plate System is manufactured in medical grade Titanium Alloy Ti-6AI-4V ELI as per ASTM F136. The Y3 Proximal Femoral Plate System is available in four lengths: 135, 185, 235 and 285 mm. Left and right versions are offered to accommodate the anatomical shape of the proximal femur.

The GAP Endo-Exo Medullary System is indicated as a temporary implant to assure alignment, stabilization and fixation of long bones that have been surgically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. The GAP Endo-Exo Medullary System is used for pediatric patients (child and adolescent) ages 2 to 21. It is indicated for correction of the following conditions: - Diaphyseal fracture of the femur, tibia and humerus ● - . Fractures of the femoral neck - Subtrochanteric, intertrochanteric and combination fractures ● - . Correction of deformities (OI, Coxa vara, Coxa valga) - . Nonunions and malunions

The GAP Endo-Exo Medullary System consists of an intramedullary cannulated nail linked to various types of plates via lag and/or mechanical screws creating a combined Endomedullary/ Exomedullary osteosythesis device. The nail is available is diameters ranging from 4.8 to 12.0mm in 0.8mm increments. Lengths available range from 160 to 320mm. 2.5, 3 and 4mm cortical screws are used to secure the nail to the bone.

The SLIM System is intended as a temporary implant for alignment, stabilization of long bones that have been surgically prepared (osteotomy) for correction of deformities, or have sustained fractures due to trauma or disease. This includes the femur, tibia, humerus, ulna and fibula of the pediatric population (child and adolescent) , and patients with small intramedulary canals affected by skeletal displasias, osteogenesis imperfecta or other bone diseases.

The Simple Locking IntraMedullary (SLIM) System consists of intramedullary fixation devices for use in long bones. The solid shaft and bevelled point are designed for quided insertion through the medullary canal. Anchorage of the device is achieved through a conical thread for a wedged fixation in the epiphyses or cortical bone, which aims to reduce the risk of migration. Internal features, such as a hexagonal drive and an internal mechanical thread in the device, allow for capture and quidance during insertion and retrieval. Additional proximal and distal locking holes provide supplementary pinning options when required. The SLIM, single-use, implants are manufactured in medical grade Stainless Steel (SS316L, ASTM F138). The rods are available in seven diameters: 2.0, 2.6. 3.2, 4.0. 4.8, 5.6 and 6.4 mm, from 80mm up to 400 mm in length.

The Free-Gliding SCFE Screw System is indicated as a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in all pediatric patients (less than or equal to 21 years old) with the exclusion of newborn and infants under 2 years of age.

The Free Glidinq SCFE Screw is a self-extending cannulated screw for use in fixation of slipped capital femoral epiphysis and femoral neck fractures. The design of the screw includes a male component (which is attached to the lateral cortex) and a female component (which is attached at the proximal epiphysis). Anchorage of the components is achieved through screw-type fixation. The screw has a built-in feature that allows for free extension of its length as the slipped capital physeal plate heals and normal patient growth continues. Stable fixation and rotational stability is created at the fracture (slip) site while avoiding compression forces thus avoiding premature closure of the physeal plate.

The GAP Endo-Exo Medullary System is indicated as a temporary implant to assure alignment, stabilization and fixation of: long bones that have been surqically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. The GAP Endo-Exo Medullary System is used for pediatric patients (child and adolescent) age 2 to 21. It can be used to correct the following conditions: - Diaphyseal facture of the femur, tibia and humerus . - Fractures of the femoral neck . - . Subtrochanteric, intertrochanteric and combination fractures - . Correction of deformities (OI, Coxa vara, Coxa valga) - . Nonunions and malunions

The GAP Endo-Exo Medullary System consists of an intramedullary cannulated nail linked to various types of plates via and/or mechanical screws creating a a combined laq Endoamedullary/ Exomedullary osteosythesis device. 3 and 4mm cortical screws are used to secure the nail to the bone.

The Hinge Pediatric Plating System is indicated as a temporary implant to aid in the correction of the angle of growth of long bones by inhibiting longitudinal growth of the physis in pediatric patients. It can be used to correct the following conditions: - Femur and tibia: varus, valgus, flexion or extension deformities of the knee. . - . Humerus: valgus or varus deformities of the elbow. - Radius and Ulna: flexion or extension deformities of the wrist. . - Ankle: varus, valgus or plantar flexion deformities of the ankle. .

The Hinge Pediatric Plating System is a three-component device made of Medical Grade Stainless Steel. The components are a plate and two screws of different sizes.

This implant is indicated as a temporary implant to aid in the healing of long diaphysis fractures, osteotomies, malunions and nonunions and to prevent further fractures in femur, tibia and humerus in pediatric patients suffering from Osteogenesis Imperfecta without disrupting the bone growth plate. It can be used in procedures such as bone lengthening concomitantly with external fixators in pediatric or small statured patients with limb length discrepancy.

The Fassier-Duval Pediatric IM System is a telescopic rod for use in fixation of long bone fractures. The design of the nail includes a female component (which is attached to the proximal -trochanteric- cortex of the bone) and a male component (which is attached to the distal cortex of the bone). Anchorage of the components is achieved through screw-type fixation or a locking pin. The nail is composed of two sliding components that allow for extension of its length as the bone structures heal and normal patient growth occurs. The Fassier-Duval Pediatric IM System can be attached to bony structures without disrupting the bone growth plates.