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- Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., 1. avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. - Those patients with failed previous surgery where pain, deformity, or dysfunction 2. persists. - Revision of previously failed arthroplasty. 3. The Natural-Hip™ System Porous Stem with HA/CSTi™ is intended only for use without bone cement.

The Natural-Hip System Porous Stem with HA/CSTi is a straight stem manufactured from Ti-6Al-4V alloy conforming to ASTM F-136. The stem is available in both a collared and collarless design. The proximal anterior surface of the stem employs anterior angulation or build-up to match the anatomic angulation of a natural femur. The superior portion of the stem has a built-in anteversion of nine degrees to match the anatomic anteversion of the femur. Circumferential hydroxylapatite coated Cancellous Structured Titanium™ (CSTi™) porous coating provides biological fixation in a cementless application. The distal portion of the Natural-Hip System Porous Stem with HA/CSTi employs ribs and flutes on the anterior and posterior sides to enhance cortical contact, thereby providing rotational stability to the hip stem. In addition, the distal portion of the stem has a flared coronal slot which reduces stiffness of the stem.

The Natural-Knee II Revision Femoral Spacer Lugs are intended for cemented use with the previously cleared Natural-Knee II Revision Femoral Component and associated components (e.g., tibial, patellar, etc.) in the treatment of: - Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular 1. necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. - Correctable valgus-varus deformity and moderate flexion contracture. 2. - Those patients with failed previous surgery where pain, deformity or dysfunction persists. 3. - Revision of previously failed knee arthroplasty. 4.

The Natural-Knee II Revision Femoral Spacer Lug is in effect a bolt. The threaded portion of the lug screws into blind holes on the inner box of the Natural-Knee II Revision Femoral Component. A large hexagonal head allows the lug to be tightened into place. When used with a femoral spacer, the lug holds the spacer component firmly in place. When used without the spacer, the lug provides medial-lateral stability similar to that of conventionally cast or machined pegs usually found on the inner box of most femoral components.

The Natural-Hip System CoCr Revision Stem is intended to replace the anatomy of the femur in cases of total hip or hemi-hip replacement. The Natural-Hip System CoCr Revision Stem is intended for cemented application only and is intended for single use only. The Natural-Hip System CoCr Revision Stem is intended for use in treatment of the following: Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. Those patients with failed previous surgery where pain, deformity or dysfunction persists. Revision of previously failed arthroplasty.

The Natural-Hip System CoCr Revision Stem is fabricated from either forged or wrought cobalt chromium alloy which conforms to the American Standards for Testing and Materials (ASTM) standards F-799 or F-1537, respectively. The Natural-Hip System CoCr Revision Stem features a threaded Sulzer 12/14 configured neck trunnion for attachment to IOI's currently marketed femoral heads, including Biolox and Zirconia heads, employing a Sulzer 12/14 configured bore. The Natural-Hip System CoCr Revision Stem is available in both a collared and collarless design. The proximal one-third of the stem's surface employs normalization steps and is roughened via the process of grit blasting. The normalization steps and grit blasted surface enhance cement compression and bonding for optimal fixation of the hip stem in the femoral canal. The proximal surface of the Natural-Hip System CoCr Revision Stem also employs polymethylmethacrylate (PMMA) cement centralizers to provide even cement mantle when the stem is implanted in the femur. The distal portion of the Natural-Hip System CoCr Revision Stem is bowed to mimic the anatomy of the femur. The Natural-Hip System CoCr Revision Stem employs a hole in the distal portion of the stem to allow the use of a PMMA centralizer for correct distal alignment.

The Select Shoulder Curved-back Pegged All-Poly Glenoids, when used with one of the Select Shoulder Humeral Stems and Humeral Heads, are intended only for use with bone cement in cases of total shoulder arthroplasty for treatment of the following: - Patient conditions, including but not limited to, noninflammatory degenerative joint > 1. disease (NIDJD), e.g., osteoarthritis or post-traumatic arthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. - Complex acute fractures, fracture-dislocations of the humeral head, malunion or non-2. union of a small osteoporotic head fragment, chronic, recurrent or acute dislocation with loss of humeral head cartilage, or large impression fractures. - Those patients with failed previous surgery where pain, deformity, or dysfunction 3. persists. - Failed previous surgery, including joint reconstruction, internal fixation, nonunion of the 4. humeral neck, arthrodesis or hemiarthroplasty. - 5. Cuff tear arthropathy. - Avascular necrosis or osteonecrosis of the humeral head. 6. - Tumor resection. 7.

The Curved-back Pegged All-Poly Glenoid is a one piece, polyethylene (ASTM F648) design intended to reproduce the function of the natural glenoid. The design is such that the component may be used in either the right or left shoulder. The implant is cemented into the subchondral bone of the glenoid cavity providing a cement mantle of approximately 1-2 mm. This design features a curved articulating surface. The component has two grooved pegs bounded by two dovetail cement grooves which provide translational and rotational stability to the implant as well as to enhance cement fixation. The grooves in the pegs also allow the surgeon to intraoperatively trim the length in the glenoid vault is shallow and prevents the full length from being seated. Titanium (ASTM F136) x-ray marker pins are incorporated in the superior aspects of the component to assist in postoperative evaluation. The lateral surface of the glenoid component accommodates the humeral head. The articulating geometry is nonconstrained for greater range of motion and greater translation.

The Natural-Hip System CoCr Stem is intended to replace the anatomy of the femur in cases of total hip or hemi-hip replacement. The Natural-Hip System is intended for cemented application only. The general indications associated with the use of Natural-Hip System CoCr Stem in total hip arthroplasty include: Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., 1. avascular necrosis, ostooarthritis and inflammatory joint disease (JJD), e.g., rheumatoid arthritis. 2. Those patients with failed previous surgery where pain, deformity or dysfunction persiss. Revision of previously failed arthroplasty. 3.

The Natural-Hip System CoCr Stem is a straight stem employing a proximal wedge shaped design. The stem is available in both a collarless design. The proximal one-third of the stem's surface is grit blasted. Normalization steps are also located on the proximal portion of the stem. The grit blasted surface and normalization steps enhance cement compression and bonding for optimal fixation of the hip stern in the femoral canal. The Natural-Hip System CoCr Stem employs a Sulzer 12/14 configured neck trumion for attachment to Intermedics Orthopedics, Inc.'s femoral heads, including Biolox and Zirconia ceramic heads, featuring a Sulzer 12/14 configured bore. The Natural-Hip System CoCr Stem has a hole in the distal portion of the stem to allow the use of a distal centralizer for correct distal alignment. The stern also employs proximal PMMA centralizers which, along with the distal centralizer, provide for an even cement mantle. This device is intended for single use only.

This device is intended to replace the proximal, distal or total femur, especially in cases that require extensive resection and restoration. Replacement of the distal femur would also include replacement of the proximal tibia and the possible resurfacing of the patella, if necessary. Proximal replacement components are available for press-fit or cemented application. Components used for replacement of the distal femur are for cemented use only. Specific diagnostic indications for use of the MOST include: metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell turnors, bone tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur; revision cases requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur: and. severe conditions of inflammatory or noninflammatory degenerative joint disease that require extensive resection(s) and replacentent(s) of the proximal and/or distal femur.

The Modular Options for Severe bone loss and Trauma (MOST) System will be used for the replacement of the proximal, distal or total femur. Replacement of the distal femur would also include replacement of the proximal tibia and the possible resurfacing of the patella, if necessary, Unlike primary hip and knee systems, this system will be used where the amount of femoral resection and restoration required is extreme (e.g., in oncology cases). The modularity of this system allows for the resection of varying amounts of the femur (and the proximal tibia and patella, if necessary) before implantation. A total replacement is possible in those cases where no part of the femur can be salvaged. The components of the MOST System include: the proximal femoral replacement that is available in two designs to address the presence or absence of the greater rochanter, with sunure holes for soft tissue attachment; the distal femoral replacement which mates with a tibial component via a hinge-type mechanism, allowing 15 degrees of internal and external rountion; intramedullary (I/M) stems with Cancellous Structured Titanium (CSTi) and femoral segments which will be used in conjunction with the proximal and distal replacements, and, an all-poly patella.

The general indications associated with the use of Patellofemoral Joint Prosthesis in patellofemoral arthroplasty include: - 1. Patients with osteoarthritis in the distal femur and patella. - Patients with a history of patellar dislocation or patellar 2. fracture. - 3. Those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.

The design of the Patellofemoral Joint Prosthesis closely replicates the anatomic features of the patellar groove on a femur. In addition, the design of the highly polished concave gliding anterior surface of the Patellofemoral Joint Prosthesis is identical to the proximal anterior surface of the articulating geometry of the Natural Knee II System's femoral component which has been determined substantially equivalent by the FDA via 510(k) K936159. The highly polished concave gliding surface of the Patellofemoral Joint Prosthesis complements the design of the articulating geometry of the IOI's patella components for optimal patellar tracking. The posterior surface of the Patellofemoral Joint Prosthesis employs two fixation pegs for enhanced stability of the prosthesis when cemented into the femur. In addition, the posterior surface of the Patellofemoral Joint Prosthesis employs a grit blasted roughened surface to facilitate interdigitation with bone cement. The roughness of the grit blasted surface ranges from 175 - 225 uinch. The Patellofemoral Joint Prosthesis is an asymmetrically designed component and, therefore, is available in both left and right configurations.

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The Natural Hip System Porous Stem is identical in design geometry as compared to the predicate IOI Porous Natural Hip Stem, except for the reduction in the neck length. This design change was intended to address various patient population in cases of total hip or hemi-hip arthroplasty. The Natural Hip System Porous Stem employs a Sulzer 12/14 configured neck trunnion for attachment to IOI's femoral heads, including Biolox and Zirconia ceramic heads. featuring a Sulzer 12/14 configured bore. The Natural Hip System Porous Stem is available in both collared and collarless design. The Natural Hip System with Collar employs Cancellous Structured Titanium (CSTi™) porous coating on the inferior surface of the collar. The proximal surface of the Natural Hip System Porous Stem employs anterior angulation to match the anatomic angulation of a natural femur. In addition, the proximal surface of the Natural Hip System Porous Stem employs circumferential CSTi™ porous coating The distal portion of the Natural Hip System Porous Stem employs ribs and flutes on the anterior and posterior sides of the hip stem. In addition, the distal portion of the Natural Hip System Porous Stem employs a flared coronal slot.

The InterMoore Fracture Hip Stem is intended for prosthetic replacement of the proximal portion of the femur in hip replacements (i.e., total hip replacement or hemi-arthroplasty).

The InterMoore Fracture Hip Stem is intended for prosthetic replacement of the proximal portion of the femur in hip replacements (i.e., total hip replacement or hemi-arthroplasty). This device will be manufactured from either cast, forged, or wrought Cobalt-Chromium (CoCr) alloy conforming to ASTM Standards F75, F799, and F1537, respectively. This straight stem is offered in a variety of sizes to allow the surgeon to replicate the natural anatomy of the hip joint as closely as possible when performing a femoral replacement. In addition, the InterMoore Fracture Hip Stem: - i has a broad collar which wraps around the anterior, medial, and posterior sides. - I incorporates a stem-neck angle which replicates natural anatomy. - E is available in a fenestrated design for press-fit applications and a solid design for press-fit and cemented applications. - 트 has a 12/14 Morse-type male taper making it compatible with any Intermedics Orthopedics, Inc. 12/14 metal femoral head (e.g., modular femoral head, unipolar) or bipolar component which utilizes a 12/14 modular femoral head. - 트 provides lateral offsets ranging from 32 to 49mm. - 부 incorporates I-beam grooves along the anterior and posterior surfaces to increase rotational stability in vivo. - 트 has a roughened/grit-blasted surface below the collar, to enhance fixation in vivo. - 트 will incorporate a proximal, lateral fin to the fenestrated design. This fin will increase the rotational stability of the implant in vivo.

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The Select Shoulder Humeral Stem is a metallic humeral component manufactured from cobalt chrome alloy (CoCrMo) and is intended for use with bone cement in total shoulder arthroplasty. The humeral stem is available in a variety of sizes and features a proximally grit blasted surface (except for the head stem taper) for enhanced cement fixation. The proximal trapezoidal shape tapers in the A-P plane, thus providing for a stable cement mande. The proximal body also features an antirotation fin on the lateral aspect. Suture holes are provided in the medial proximal body and lateral fin to allow for soft tissue/bony fragment attachment and tensioning, thus resulting in a more biomechanically stable construct for repair for proximal fractures. A male IOI morse type taper permits attachment of one of the metallic humeral heads offered by Intermedics Orthopedics. This taper is identical to the taper of the previously cleared Select Shoulder System. Distally, the stem is rounded and fluted to provide enhanced fixation and rotational stability. The distal stem tip is designed to accept a cement centralizer. The humeral stem is designed for use with Intermedics Orthopedics humeral heads and glenoid components in a variety of sizes and heights for increased stability of the glenohumeral joint.