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The MC-Subtalar™ II screw system is for the correction of flexible flat feet in children (6 to < 12 years of age) and adolescence (12 to < 13 years of age). It is intended to block medial and plantar pronation of the talus, while, allowing normal subtalar joint motion. Specific indications for use include: - Flexible flat feet in children and adolescence, - Progression medial talus protrusion, - Loss of longitudinal arch, - Pain along the tibialis posterior, - Age > 6 years, after conservative treatment did not result in a flat foot correction, - Age < 13 years, while the deformity may be corrected manually.

The MC-Subtalar™ II screws are partly threaded, cannulated and self-tapping screws. They are designed to be implanted into the calcaneus bone of the foot for subtalar extra-articular arthroeresis. A hexagonal shaped shaft end allows easy adjustment while operation. The screws are made of X2CrNiMo 18-15-3 stainless steel and are also available made of Ti6Al4V titanium alloy. The MC-Subtalar™ II is offered in sizes of 25 mm, 30 mm and 35 mm and with different head diameter of 6 mm, 8 mm and 10 mm to meet the specific anatomical requirements for various age groups.

Indications for use include fixation of fractures. For specific screw indications please see below. MetaFixTM LS Locking Screws - · For adult and pediatric patients - · In combination with Merete Locking Plates - · Fixation of fractures, osteotomies, non unions of the clavicle, scapula, olecranon, radius, ulna, fibula, metacarpals, metatarsals - · Hallux Valgus osteotomy correction, middle hand and middle foot bones and particular in osteopenic bone Merete® Cannulated PCS - · For adult and pediatric patients - · Fixation of fresh fractures - · Revision procedures - · Joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes Merete® CS Cortical Screws - · For adult and pediatric patients - · Fixation of fresh fractures - · Revision procedures - · Joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes Merete® Cannulated HCS - · Fixation of fractures and reconstruction of various bones - · Osteotomies in the foot (as Hallux Valgus) or hand - · Athrodesis in hand, foot or ankle surgery - · Fixation of bone fragments in long bones or small bone fractures DuoThread™ Scarf Screws - · Small bone fracture fixation - · Fixation and stabilization of bones of the feet - · Osteotomies (Scarf-Osteotomy, Chevron-Austin Osteotomy, Closing Wedge Osteotomy) - · Fusion (MPG-Athrodesis) - · Fixation of almost all common osteotomies of the first metatarsal TwistCut™ Snap-Off Screws - · Fixation of fractures and reconstruction of bones - · Fixation of small bone fragments - · Mono cortical fixation - · Osteotomies (Weil-Osteotomy) - · Fracture fixation in the foot and hand

MetaFix™ LS Locking Screws: The screws are fully threaded and self-tapping with a threaded head to lock into Merete Locking plates. Locking screws/plates incorporate a screw-to-plate locking feature which creates a locked, fixed angle construction to hold fracture or osteotomy reduction. The screws are made of titanium (ASTM F-136) and are available in the lengths from 12 mm (Ø3.0 mm), 12 mm to 48 mm (Ø3.5 mm) and 10 mm to 48 mm (Ø3.8 mm). Merete® Cannulated PCS: The Merete® Cannulated PCS screw is a partly threaded, self-tapping, self-drilling and cannulated compression screw. The screws are made of titanium (ASTM-F136) and are available in the lengths from 12 mm to 48 mm (Ø3.0 mm). The wrench type of the screw is a torx socket. Merete® CS Cortical Screws: The Merete® CS Cortical Screw is fully or partly threaded and self-tapping. The screws are made of titanium (ASTM-F136) and are available in the lengths from 10 mm (Ø3.0 mm or Ø3.5 mm). The wrench type of the screw is a torx socket. Merete® Cannulated HCS: The Merete® Cannulated HCS screw is a partly threaded, self-tapping, self-drilling and cannulated headless compression screw. The screw is featured with a sinkable threaded head. The thread pitch of the shaft and the head are different to achieve a better compression. The screws are made of titanium (ASTM F-136) and are available in the lengths from 12 mm to 40 mm (Ø3.0 mm to 60 mm (Ø4.3 mm). The wrench type of the screw is a torx socket. DuoThread™ Scarf Screws: The DuoThread™ Scarf screw is a partly or fully threaded, cannulated compression screw. The compression is obtained through a different thread pitch at the head of the screw. The screws are made of titanium (ASTM-F136) and are available in the lengths from 10 mm to 34 mm (Ø3.0 mm). The wrench type of the screw is a torx socket. TwistCut™ Snap-Off Screws: The TwistCut™ Snap-Off screw is self-tapping and self-drilling. The screw has a shank to chuck it into a K-Wire pistol, which is cut off when the screw head hits the cortex. The screws are made of titanium (ASTM-F136) and are available in the lengths from 11 mm to 14 mm (Ø2.0 mm).

The PediatrOS™ RigidTack™/ FlexTack™ bone staples are indicated for pediatric patients (children/ adolescents) with angular deformities or leg length discrepancies. Therefore PediatrOS™ RigidTack™ / FlexTack™ is intended to redirect the angle of growth of long bones and to correct leg length discrepancies by inhibition of longitudinal growth of the physis (growth plate) in growing children and adolescents. Specific pediatric conditions/diseases for which the devices will be indicated include: - Valgus, varus, or flexion, extension, deformities of the knee (femur and/or tibia) ● - Valqus or varus deformities of the elbow (humerus) ● - Leg length discrepancies ●

**PediatrOS™ RigidTack™** The PediatrOS™ RigidTack™ bone staples are used to correct leg length discrepancies through (dual) epiphysiodesis of long bones. The PediatrOS™ RigidTack™ has a trapezoidal shape which allows the staples to fit well to the epiphyseal bone. The staples are made from titanium alloy TiAl6V4 ELI and are available in several sizes, so they can be used for children of various age groups (before reaching skeletal maturity). The jagged surfaces of the staples' legs help secure it into the bone to prevent loosening. The staples have cannulated legs to facilitate placement through K-wires. In order to achieve a stiff mechanical behavior, the staples are equipped with a support strut. Female threads, built in the cannulated legs, help to remove the staples with threaded K-wires and the appropriate explantation instruments. **PediatrOS™ FlexTack™** The PediatrOS™ FlexTack™ bone staples are used to correct axial deformities through hemiepiphysiodesis of long bones. The PediatrOS™ FlexTack™ has a trapezoidal shape which allows the staples to fit well to the epiphyseal bone. The staples are made from titanium alloy TiAl6V4 ELl and are available in several sizes, so they can be used for children of various age groups (before reaching skeletal maturity). The jagged surface of the staples' legs help secure it into the bone to prevent loosening. The staples have cannulated legs to facilitate placement through K-wires as well as a flexible middle part which can be bent in vivo by the strength of bone growth permitting successive growth delay. Female threads, built in the cannulated legs, help to remove the staples with threaded K-wires and the appropriate explantation instruments.

The device is intended to be used in the management of segmental diaphyseal bone loss of the femur in oncology patients secondary to radical bone loss and/or resection due to tumors. The intramedullary rods can be fixed with interlocking screws without or with bone cement.

The OsteoBridge™ IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System is a series of modular intramedullary rod segments that may be used as either proximal or distal segments. The segments are designed to be attached together to form a complete intramedullary rod using semicircular hollow attachment shells that are clamped together with multiple screws to create a complete intramedullary rod. The complete unit is designed to accept interlocking bone screws for additional rotational stability. The implants from this submission are an extension of the OsteoBridge™ IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System (K051965/K113303). The components from this submission can be used in combination with the rod segments from the OsteoBridge™ IDSF diameter 10 to 16 mm (K051965) as well as with the dia. 5 mm interlocking screws. In addition sterile intramedullary rod segments are available in diameters of 18 mm and 20 mm in lengths of 90 mm and 110 mm. The hollow central attachment shell for use in the femur has a diameter of 34 mm and is available in four lengths 40 mm, 50 mm, 60 mm and 70 mm with reducing bushings to allow the use of different diameter rods proximally and distally to better fit the medullary canal. If the defect size is larger than 70 mm, two attachment shells can be connected by a spacer connector. All components of the OsteoBridge™ IDSF system are manufactured from Ti-6Al-4V titanium alloy conforming to ASTM F 136-13.

The IntraBlock™ BioBall™ Hip System (IBS) is intended for use in total hip arthroplasty. The IBS is indicated for: - Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, - Avascular necrosis of the femoral head, - - = Correction of functional deformity, - Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques, - -Revision procedures where other treatment or devices have failed. The IBS is indicated for cementless use only.

The IntraBlock™ BioBall™ Hip System (IBS) is composed of femoral stems, heads, taper adapter sleeves and acetabulum cups. The System is designed for uncemented use for either primary or revision hip arthroplasty. The Ceramic Head is made of Biolox® delta (Alumina Matrix Composite ISO 6474-2) and available in diameters 28, 32 and 36 mm. The cementless MultiCup Locking PressFit is manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F-136 with a titanium plasma spray (TPS) coating on the outer surface. It is used with a UHMWPE Inlay sized for Ø28, 32 and 36 mm heads. 5 holes with threaded plugs give the option for an additional fixation with locking screws. The MultiCup is available in 9 different sizes ranged from 46 mm, 48 mm up to 62 mm outer diameter.

The Merete Locking Bone Plate System can be used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes.

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The Merete BLP™ Small Fragment Locking Bone Plate System is used for adult and pediatric patients as indicated for small bone fracture fixation. Indications for use include fixation of fractures, osteotomies, non-unions of the clavicle, scapula, olecranon, radius, ulna, fibula, metacarpals, metatarsals, Hallux Valgus osteotomy corrections, middle hand and middle foot bones, particular in osteopenic bone.

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The IntraBlock™ BioBall™ Hip System (IBS) is intended for use in total hip arthroplasty. The IBS is indicated for: - Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, - -Avascular necrosis of the femoral head, - Correction of functional deformity. ー - -Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques, - Revision procedures where other treatment or devices have failed. - AND/OR The IBS is indicated for cementless use only.

The IntraBlock™ BioBall™ Hip System (IBS) is composed of femoral stems, heads. taper adapter sleeves and acetabulum cups. The System is designed for uncemented use for either primary or revision hip arthroplasty. The IBS stem is straight, collarless, and flat with a tapered design. The stem is manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F-136 with a proximal titanium plasma spray (TPS) coating. The stems are proportionally sized and shaped in sizes 6.25 mm to 15.00 mm to match the geometry of the femur. A lateralized version of the device is available. Both versions have a neck shaft angle of 135° and a 12/14 morse taper trunion. The Ceramic Head is made of Biolox® delta (Alumina Matrix Composite ISO 6474-2) and available in diameter 28 mm. The taper adapter sleeves are made from titanium alloy (Ti-6AI-4V ELI) with a 12/14 morse taper trunion in the four neck lengths S, M, L and XL. The cementless MultiCup Locking PressFit is manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F-136 with a titanium plasma spray (TPS) coating on the outer surface. It is used with a UHMWPE inlay sized for Ø28 mm heads. 5 holes with threaded plugs give the option for an additional fixation with locking screws. The MultiCup is available in 9 different sizes ranged from 48mm up to 62mm outer diameter.

Merete® CS, Cortical Screws 3.0 and 3.5mm can be used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hands, feet, wrists, ankles, fingers and toes.

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The Merete Locking Bone Plate System III can be used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes.

The Merete Locking Bone Plate System III consists of contoured, anatomically shaped locking bone plates in various sizes and different curvatures for the fixation with Merete 3.0 and 3.5 mm locking screws and 3.0 mm cannulated compression screws. Before placing the screws, plates can be fixed temporarily with K-Wires. Plates, screws and K-Wires of the Merete Locking Bone Plate System III are made of Ti-6Al-4V ELI Alloy for Surgical Implant Applications (ASTM F136, ISO 5832-3). K-Wires are additionally made of CrNiMo Stainless Steel for Surgical Implants (ASTM F138, ISO 5832-1).