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The Balanced Knee System TriMax PS Plus Tibial Inset is in cemented total knee arthroplasty procedures with the following indications: 1. Loss of knee joint configuration and joint function. 2. Osteoarthritis of the knee joint. 3. Rheumatoid arthritis of the knee joint. 4. Post-traumatic arthritis of the knee joint. 5. Valgus, varus, or flexion deformities of the knee joint. 6. Revision procedures where other treatments or devices have failed.

The Balanced Knee® System (BKS) TriMax PS Plus Tibial Insert is a line extension of the TriMax PS Tibial Insert (K131337) that offers slightly more constraint than the original PS Insert. The PS post geometry is the only design difference between the previously cleared predicate device and the subject device. The change slightly modifies the post's shape to provide additional internal/external and varus/valgus constraint if the surgeon determines the need exists. The balance of the design is identical including the articulating surface, locking mechanism, as well as the PS post location and height. The PS Plus inserts are intended for use in primary and revision knee surgeries with the same indications for use as the predicate. This implant is used with existing BKS and BKS Revision (BKSR) tibial travs. TriMax femoral components and the BKSR modular femoral components. The material is identical as well as all manufacturing processes, cleaning, sterilization and packaging that were cleared under K131337.

The Progen™ short trochanteric nail is indicated for fixation of various types of stable and unstable neck, intertrochanteric, and peritrochanteric fractures. The Progen™ long trochanteric nail is intended for fixation of stable femoral fractures occurring from the base of the femoral neck extending distally to a point approximal to the intercondylar notch including fractures of the basilar neck, intertrochanteric fractures, subtrochanteric fracture, femoral shaft fractures, pathological fractures, impending pathological fractures, tumor resection, nonunion, and revisions. The Progen™ long trochanteric nail is intended for fixation of stable and unstable femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10cm proximal to the intercondylar notch including fractures of the basilar neck, intertrochanteric fractures, peritrochanteric fractures, subtrochanteric fracture, femoral shaft fractures, pathological fractures, impending pathological fractures, tumor resection, nonunion, malunion, and revisions.

The Progen™ Trochanteric Nail System consists of temporary fixation intramedullary nails and their accompanying instrumentation designed for fracture fixation and stabilization of the femur. The implants are available in various lengths and diameters to accommodate a range of patient anatomy. Each of the intramedullary nails is secured by a sequence of screws that transect through holes in the proximal and distal sections of each nail. The Progen™ Trochanteric Nail System consists of single-use intramedullary nails for stable and unstable neck, intertrochanteric, pertrochanteric, and subtrochanteric fractures and combinations of these fractures. The system consists of Nail, Lag Screw, Secondary Screw, Lag Cap, Locking Screws, Set Screws, and Nail End Cap. The nails and accompanying components are manufactured from titanium alloy (Ti-6Al-4V ELI). Additionally, the Nails and Lag Screws have a Type II anodized surface treatments.

1. Non-inflammatory degenerative joint diseases (NIDJD), e.g., osteoarthritis, avascular necrosis 2. Traumatic arthritis 3. Previous tibial condyle or plateau fracture with loss of anatomy or function 4. Varus deformities 5. Revision of the tibial bearing insert of a previously implanted unicompartmental knee system provided that the tibial tray mechanism is not compromised, and femoral and tibial tray components remain well fixed and undamaged. The BKS Uni is intended for unicompartmental knee arthroplasty procedures. The system is single-use and intended for implantation with bone cement.

The Balanced Knee® System (BKS®) Uni is a single compartment knee replacement. The BKS Uni is indicated for cemented use only. Cobalt Chromium Femoral Component The femoral components are cobalt chromium (Co-Cr-Mo). The femoral components are right and left specific and are intended for cemented use only. Titanium Tibial Trays The titanium tibial trays (Ti-6Al-4V ELI) are left and right specific and are for cemented use only. Polyethylene Tibial Insert The E-Vitalize tibial insert is manufactured from crosslinked Vitamin E Ultra High Molecular Weight Polyethylene. The inserts match the respective size of the tibial tray used.

The Pisces Spinal System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, sacrum and iliac spine (T1-Sacrum/Ilium) for the following indications: 1. Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) 2. Degenerative Spondylolisthesis with objective evidence of neurologic impairment 3. Trauma (fracture or dislocation) 4. Spinal tumor 5. Failed previous fusion (pseudarthrosis) 6. Spinal stenosis 7. Spinal deformities or curvatures such as scoliosis, kyphosis, or lordosis

The Pisces Spinal System is an implantable system intended to provide immobilization and stabilization of spine segments. The subject device is a modular pedicle screw assembly that consists of pedicle screws with solid and cannulated options, modular tulips in standard, reduction, and extended tab configurations, spinal rods, and set screws. All components are made of implantable-grade titanium. The modular tulip is an assembly which consists of a tulip body, a saddle, and a locking ring. The top of the tulip body receives a locking set screw which secures the tulip body assembly to an ø5.5mm or ø6.0mm rod and pedicle screw when tightened. The pedicle screw has a spherical head which the tulip assembly snaps onto either before or after surgical insertion. The 5.5mm or 6.0mm rod is inserted into the tulip assembly. After assembly of multiple pedicle screws, a set screw is inserted into the tulip and locked to a predetermined locking torque, immobilizing the construct. For the 20mm reduction and 90mm extended tab tulips, the guide tabs are removed from the construct following final lock. 20mm reduction tabs can be used to provide length for rod reduction while 90mm tab tulips facilitate minimally invasive surgeries (MIS). All implants are provided sterile for single use only.

The Gecko Spinal System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: 1. Spinal trauma surgery, used in sublaminar or facet wiring techniques; 2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scollosis, kyphosis and spondylolisthesis; 3. Spinal degenerative surgery, as an adjunct to spinal fusions. The Gecko Spinal System may also be used in conjunction with other Ortho Development's spinal rod systems made of similar metals whenever "wiring" may help secure the attachment of the other implants.

The Gecko Spinal System is an implantable device intended to provide immobilization and stabilization of spinal segments. The device consists of an implantable polyethylene terephthalate (PET) braided band with a stiffened guiding section at one end and a metal leader at the other (both removed before final implantation), an implantable grade titanium alloy clamp that mates with 5.5mm diameter rods, and an implantable grade titanium alloy nut that secures the band, clamp, and connecting rod together. All implants are provided sterile for single use only; the implant should not be re-used or re-sterilized under any circumstances.

These devices are intended for use in total knee arthroplasty procedures for the following conditions: 1. Loss of joint configuration and joint function. 2. Osteoarthritis of the knee joint. 3. Rheumatoid arthritis of the knee joint. 4. Post-traumatic arthritis of the knee joint. 5. Valgus, varus, or flexion deformities of the knee joint. 6. Revision procedures where other treatments or devices have failed. The BKS Revision is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves, cones or stem extensions. The BKS Revision System Trabecular Tibial Cone Augments are for cemented or cementless use.

The Balanced Knee® Revision System (BKS® Revision) Trabecular Tibial Cone Augments are an addition to the Balanced Knee® Revision System to provide optional single-use modular cone augment implants used in revision knee surgery. The subject device provides additional support to the tibial implant and reinforcement to the proximal tibia when bone voids are present. The subject device is designed for cemented or uncemented fixation with the bone.

These devices are intended for use in total knee arthroplasty procedures for the following conditions: 1. Loss of joint configuration and joint function. 2. Osteoarthritis of the knee joint. 3. Rheumatoid arthritis of the knee joint. 4. Post-traumatic arthritis of the knee joint. 5. Valgus, varus, or flexion deformities of the knee joint. 6. Revision procedures where other treatments or devices have failed. The BKS Revision is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves or stem extensions. The BKS Revision is indicated for cemented application only. The porous-coated metaphyseal sleeves are intended for cemented and uncemented biological fixation application.

The BKS® Revision Sleeves System expands the capabilities of the Balanced Knee® System (BKS®) Revision through the introduction of femoral and tibial sleeves, a tapered junction box, locking bolt, and a sleeve specific tibial tray. All new implants are a single-use modular system used in revision knee surgery to accommodate metaphyseal bone defects and provide rotational stability. The system is designed for cemented or uncemented fixation with the bone. The porous-coated femoral sleeve is affixed to the modular femoral component via a tapered junction box. The porous-coated tibial sleeve is affixed to a sleeve tibial tray.

This device is intended for use in total knee arthroplasty procedures for the following conditions: 1. Loss of joint configuration and joint function. 2. Osteoarthritis of the knee joint. 3. Rheumatoid arthritis of the knee joint. 4. Post-traumatic arthritis of the knee joint. 5. Valgus, varus, or flexion deformities of the knee joint. 6. Revision procedures where other treatments or devices have failed.

The Offset Junction Box is part of the Balanced Knee® Revision System and is a single use modular device used in revision knee surgery to provide an attachment point between a modular femoral component and a stem extension. The Offset Junction Box is available in four size options: 0mm and 5mm offset configurations with either a 5° or 7° valgus angle.

This device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of: - Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis. - Previously failed hip surgery. - Fractures of the femoral neck or head. - Avascular necrosis of the femoral head. - Congenital dysplasia or other structural abnormalities where sufficient bone stock exists to prosthesis.

The proposed subject device is a line extension to the acetabular cup system previously cleared in K103384. The predicate is a modular system intended for the replacement of the natural articular surface of the hip joint in total hip replacement surgery. The system consists of acetabular shells, liners, bone screws, apical screw hole cover, and femoral heads. The subject and predicate acetabular liners are both made of highly cross-linked polyethylene and are hemispherical in shape with positive locking, liner stabilization, and anti-rotation features. The Legend Acetabular Liners (subject device) differ from the predicate device, cleared in K103384, through the addition of new sizes. Other components of the system have not been modified and are not a part of this submission other than by reference.

This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of: 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis. 2. Previously failed hip surgery. 3. Proximal femoral neck fractures or dislocation. 4. Idiopathic avascular necrosis of the femoral head. 5. Non-union of proximal femoral neck fractures. 6. Treatment of fractures that are unmanageable using other forms of therapy. 7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where stock exists to properly seat the prosthesis.

Entrada™ hip stem is a single-piece, tapered, collared and non-collared, hydroxyapatite (HA) coated femoral hip stem designed for single use. The stem has a neck with a 12/14 trunnion taper for modular attachment to femoral heads. Entrada™ hip stem is manufactured from titanium alloy and device fixation is achieved through uncemented press-fit in the medullary canal and through the use of biocompatible HA coating. The stem has a variety of sizes to accommodate the majority of patients encountered: lengths (95-160mm), horizontal offsets (35-55mm), vertical offsets (29-34mm), resection angle of 45°, and neck angle of 132°. The stem is offered with both standard (STD) and extended (EXT) offsets and with and without a collar.