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The APEX 3D™ Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. In the United States, components are intended for cemented use only.

The APEX 3D Total Ankle Replacement System has been cleared under K192994. The purpose of this submission is to introduce a new diffusion bonded talar dome to the APEX 3D Total Ankle Replacement System. The APEX 3D Total Ankle Replacement System is a cemented, fixed-bearing device comprised of a tibial component, a talar component, and a UHMWPE component used for ankle joint replacement. Based on patient anatomy, a number of component sizes and design configurations can be selected for best fit.

The Monkey Bars Pin to Bar External Fixation System is intended to be used in adult and pediatric patients (specifically, children and adolescents aged 2 through 21 years) for provisional fixation of open and/or unstable fractures in the lower and upper extremities and pelvis. It may also be used for temporary fixation of peri-articular or intra-articular fractures. Additionally, the device can be used on fractures where soft tissue injury or an infected fracture site may preclude the use of other fracture fixation treatments.

The device is used for the external stabilization of bone fractures. It consists of: Carbon fiber composite bars, 11mm diameter by 150mm to 500mm lengths, titanium combination clamp, aluminum 5 & 8 hole multi-pin clamps, aluminum straight and 30 degree angled posts, stainless steel 3mm, 4mm and 5mm thread diameter pins with 5mm diameter shanks that come in blunt tip and self tapping with 125mm through 230mm overall lengths and 20mm through 65mm thread lengths, stainless steel transfixing pin with 5mm shank, 7.2mm thread diameter, and 325mm overall length, and stainless steel instruments for implantation. The pins are implanted into bone and then they are connected using the clamps, rods and posts to form a rigid construct which holds the bone fragments rigidly in place. The pins are offered in various lengths and thicknesses.

The Phantom Fibula Nail System is intended for use in the fixation of fibular fractures and osteotomies.

The Phantom Fibula Nail System consists of nails, screws, and accessories for the intended use of fibula repair. The implants are provided in multiple sizes and lengths.

The APEX 3D Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. In the United States, components are intended for cemented use only.

The APEX 3D Total Ankle Replacement System is a cemented, fixed-bearing device comprised of a tibial component, a talar component, and a UHMWPE component used for ankle joint replacement. Based on patient anatomy, a number of component sizes and design configurations can be selected for best fit.

The Baby Gorilla/Gorilla Bone Plates and Bone Screws of the Baby Gorilla/Gorilla Plating System are indicated for use in stabilization of fractures or osteotomies; intra and extra articular fractures, ioint depression, and multi-fragmentary fractures: revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus, as well as the fingers, hands, and wrists. The system can be used in both and pediatric patients. Specific examples include: Forefoot: Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion), Metatarsal or phalangeal fractures and osteotomies, Lesser metatarsal shortening osteotomies (e.g. Weil), Fifth metatarsal fractures (e.g. Jones Fracture). Mid/Hindfoot: LisFranc Arthrodesis and/or Stabilization, 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions, Intercuneiform Fusions, Navicular-Cuneiform (NC) Fusion, Talo-Navicular (TN) Fusion, Calcaneo-Cuboid (CC) Fusion, Subtalar Fusion, Medial Column Fusion, Cuneiform Fracture, Cuboid Fracture, Navicular Fracture. Ankle: Lateral Malleolar Fractures, Syndesmosis Injuries, Medial Malleolar Fractures and Osteotomies, Bi-Malleolar Fractures, Tri-Malleolar Fractures, Posterior Malleolar Fractures, Distal Anterior Tibia Fractures, Vertical Shear Fractures of the Medial Malleolus, Pilon Fractures, Distal Tibia Shaft Fractures, Distal Fibula Shaft Fractures, Distal Tibia Periarticular Fractures, Medial Malleolar Avulsion Fractures, Lateral Malleolar Avulsion Fractures, Tibiotalocalcaneal Joint Arthrodesis, Tibiotalar Joint Arthrodesis, Tibiocalcaneal Arthrodesis, Supramalleolar Osteotomy, Fibular Osteotomy, First metatarsal osteotomies for hallux valgus correction including: Opening base wedge osteotomy, Closing base wedge osteotomy, Crescentic Osteotomy, Proximal Osteotomy (Chevron and Rotational Oblique), Distal Osteotomy (Chevron/Austin), Arthrodesis of the first metatarsophalangeal joint (MTP) including: Primary MTP Fusion due to hallux ridgidus and/or hallux valgus, Revision MTP Fusion, Revision of failed first MTP Arthroplasty implant. Flatfoot: Lateral Column Lengthening (Evans Osteotomy), Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy), Calcaneal Slide Osteotomy. Charcot: Medial column fusion (talus, navicular, cuneiform, metatarsal) for neuropathic osteoarthropathy (Charcot), Lateral column fusion (calcaneus, cuboid, metatarsal) for neuropathic osteoarthropathy (Charcot). In addition, the non-locking, titanium screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture fixation, appropriate for the size of the device. The Monster Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the device. Specific examples include: Fractures and Osteotomies: Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc), Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture), Talar fractures, Ankle fractures, Navicular fractures, Fractures of the fibula, malleolus, and calcaneus, Metatarsal and phalangeal osteotomies, Weil osteotomy, Calcaneal osteotomy. Hallux Valgus Correction: Fixation of osteotomies (i.e. Akin, Scarf, Chevron), Interphalangeal (IP) arthrodesis, Proximal, midshaft, or distal osteotomy, Lapidus arthrodesis. Arthrodesis/Deformity Correction: 1st MTP arthrodesis, Metatarsal deformity correction, Tarsometatarsal joint arthrodesis, Naviculocuneiform joint arthrodesis, Talonavicular arthrodesis, Subtalar joint arthrodesis, Triple arthrodesis, Medial column arthrodesis, Subtalar joint distraction arthrodesis, Ankle arthrodesis, Lateralizing calcaneal osteotomy, Lateral column lengthening, Hammertoe. Fusion resulting from neuropathic osteoarthropathy (Charcot) such as: Medial and lateral column, Subtalar, talonavicular, and calcaneocuboid.

Baby Gorilla/ Gorilla Plating System: The Baby Gorilla/Gorilla Plating System is comprised of bone plates, threaded bone screws, and washers. Gorilla Plates are offered in “mini” and “standard” set sizes in a variety of shapes based upon the anatomical fixation required. Screws are also offered in “mini” and “standard” sets and, in addition, in locking and non-locking versions. Size-matched washers are available for use with the non-locking screws when the latter are used for fixation without the plates. Size-matched plate washers are also available for use with plate holes when there is no desire to use a screw. The Baby Gorilla/Gorilla Plating System implants are manufactured from medical grade titanium (per ASTM F67), stainless steel (per ASTM E138) and titanium alloy (per ASTM. Monster Screw System: The Monster Screw System is comprised of threaded bone screws (Ti Alloy or Stainless Steel) offered in 2.0mm to 9.5mm diameters (in 0.5mm increments). In addition, a 2.7mm diameter is also part of the system. The overall screw length ranges from 8mm (for smaller diameters) thru 200mm (for larger diameters). The screws are available in a variety of designs including fully or partially threaded, self-drilling or blunt, cannulated or solid, and headed or headless. Sized-matched washers are also available.

The Grappler Suture Anchor R3FLEX IOL System is intended for the fixation of soft tissue to bone including: Elbow: Biceps Tendon Reattachment, Lateral Epicondylitis Repair, Tennis Elbow Repair Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC Foot/Ankle: Lateral Stabilization (Brostrom, Brostrom-Gould, Christman-Snook Repair), Ankle Ligament Repair, Medial Stabilization (Deltoid, Spring Ligament Repair), Achilles Tendon Repair, Metatarsal Ligament Repair, Syndesmosis Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, LisFranc Repair Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Extra Capsular Reconstruction, Patellar Ligament and Tendon Avulsion Repair Hip: Capsular Repair, Acetabular Labral Repair The plate interacting anchors are only indicated for the above Hand/Wrist and Foot/Ankle indications.

The Grappler Suture Anchor R3FLEX IOL System consists of suture anchors, suture, and the accompanying instrumentation for the intended use of soft tissue damage repair. The anchors are provided in titanium and all-suture and are connected by suture composed of UHMWPE.

The Monster® Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the size of the device. Specific examples include: Fractures and Osteotomies, Hallux Valgus Correction, Arthrodesis/Deformity Correction, Fusion resulting from neuropathic osteoarthropathy (Charcot). The Baby Gorilla® / Gorilla® Bone Plates and Bone Screws of the Baby Gorilla® and Gorilla® Plating System are indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus, as well as the fingers, hands, and wrists. The system can be used in both adult and pediatric patients. Specific examples include: Forefoot, Mid/Hindfoot, Ankle, First metatarsal osteotomies for hallux valgus correction, Arthrodesis of the first metatarsophalangeal joint (MTP), Flatfoot, Charcot. In addition, the non-locking titanium screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device. The Phantom® Small Bone Intramedullary Nail System is indicated for use in stabilization and fixation of the small bones of the feet and ankle for the treatment of fractures, osteotomies, nonunions, pseudarthroses and malunions by revision, joint fusion or reconstruction procedures. The Phantom® Hindfoot TTC/TC Nail System is indicated for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include: Post-traumatic or degenerative arthritis, Previously infected arthrosis, Revision of failed ankle arthrodesis, Revision of failed total ankle arthroplasty, Talar deficiency conditions such as avascular necrosis of the talus (requiring tibiocalcaneal arthrodesis), Neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle, Rheumatoid arthritis, Osteoarthritis, Nonunions or pseudarthrosis of hindfoot and distal tibia, Trauma (severe or malunited tibial pilon fracture), Charcot foot (neuroarthropathy), Severe end-stage degenerative arthritis, Instability and skeletal defects after tumor resection, Pantalar arthrodesis, Severe foot/ankle deformity. HammerTube™M System is indicated for fixation of The reconstruction and fusion of toes during correction procedures for hammertoe deformity, claw toe deformity, shortening osteotomies of the phalanges and mallet toe deformity as well as revision hammertoe procedures. The cannulated and solid HammerTube™ implants may be used without any other additional device. The cannulated implants may be used with K-Wires for delivery of implants or for the temporary stabilization of nearby joints, such as the metatarsophalangeal joint. The implantable K-Wires are indicated for use in the stabilization and fixation of small bones for use in bone reconstruction, osteotomy, arthrodesis, fracture repair and fixation, appropriate for the size of the joint. Additionally, the implantable K-Wires are indicated as guide pines for insertion of instruments and implants in the HammerTube™ System. The APEX 3D™ Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. Components are intended for cemented use only.

**Monster® Screw System:** The Monster® Screw System is comprised of threaded bone screws (Ti Alloy or Stainless Steel) offered in 2.0mm to 9.5mm diameters (in 0.5mm increments). In addition, a 2.7mm diameter is also part of the system. The overall screw length ranges from 8mm (for smaller diameters) thru 200mm (for larger diameters). The screws are available in a variety of designs including fully or partially threaded self-drilling or blunt, cannulated or solid, and headed or headless. Sized-matched washers are also available. **Baby Gorilla® / Gorilla® Plating System:** The Baby Gorilla® / Gorilla® Plating System is comprised of bone plates, threaded bone screws, and washers. Gorilla® Plates are offered in "mini" and "standard" set sizes in a variety of shapes based upon the anatomical fixation required. Screws are also offered in "mini" and "standard" sets and, in addition, in locking and non-locking versions. Size-matched washers are available for use with the non0locking screws when the latter are used for fixation without the plates. Size-matched plate washers are also available for use with plate holes when there is no desire to use a screw. The Baby Gorilla® / Gorilla® Plating System implants are manufactured from medical grade titanium (per ASTM F67), stainless steel (per ASTM F138), and titanium alloy (per ASTM F136). **Phantom® Small Bone Intramedullarv Nail System:** The Phantom® Small Bone Intramedullary Nail System is comprised of small bone intramedullary nails, locking screws and threaded pegs. The Phantom® nails are offered in a variety of lengths to accommodate variations in patient anatomy. The Phantom® threaded pegs and locking screws insert through the intramedullary nail to secure the construct. These are offered in varving lengths to accommodate the anatomical fixation required. The system includes instruments for implantation. **Phantom® Hindfoot TTC/TC Nail System:** The Phantom® Hindfoot TTC/TC Nail System is comprised of intramedullary nails, screws and accessory components. The Phantom® nails are offered in a variety of sizes lengths, and configurations to accommodate variations in patient anatomy. The Phantom® screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required. **HammerTube™ System:** The HammerTube™ System includes HammerTube™ and K-Wire implants. The HammerTube™ is a commercially pure titanium plasma sprayed PEEK cylinder in varying diameters, lengths, and angles. The K-Wires are stainless steel and double trocar pointed. The implants are sold sterile. **APEX 3D Total Ankle Replacement System:** The APEX 3D™ Total Ankle Replacement System is a cemented, fixed bearing device comprised of a tibial component, a talar component and an Ultra-High Molecular Weight Polyethylene (UHMWPE) component used for ankle joint replacement. Components are available in varying sizes and design configurations intended for both primary and revision applications.