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TGM Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components of compatible TGM Medical systems in cases of: A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. C. Proximal femoral fractures. D. Avascular necrosis of the femoral head. E. Non-union of proximal femoral neck fractures. F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa plana, coxa vara, coxa valea, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.

The Biolox® delta Ceramic Heads are modular femoral components used in hip arthroplasty. The head attaches to a femoral stem via a 12/14 Morse taper and articulates with a polyethylene acetabular component. The ceramic material is Transition-Toughened-Platelet Alumina (TTPA) consisting of 75% Alumina, 24% Zirconia and 1% Platelet. The heads are available in three diameters (28, 32 & 36mm) and a variety of offsets.

- Primary intervention of rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, A. collagen disorders, and/or avascular necrosis of the femoral condyle. - Post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion, B. dysfunction, or prior patellectomy). - Failed osteotomy or unicompartmental replacements. C. - Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone D. stock exists. - The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced E. and stabilized at the time of surgery. - Moderate valgus, varus, or flexion deformities. F. All MRKS femoral components and tibial baseplates are intended for cemented use only: All MRKS stems are intended uncemented use.

The MILESTONE Revision Knee System (MRKS) is a semi-constrained, cemented knee prosthesis designed for either primary or revision total knee arthroplasty. The MRKS contains left and right configurations of a femoral component and a fixed-bearing tibial component, in addition to accessory components including stems, augments, screws, pegs, a taper plug, and a baseplate plug. The femoral component and tibial baseplate employ modularity for stem and augment attachment. The MRKS femoral component is manufactured from cast cobalt chrome alloy. It is offered in six sizes (1-6) and is designed to articulate with the MRKS ultracongruent tibial insert and the MILESTONE Knee System (MKS) all poly patellar component (K112285). The MRKS femoral component is not designed to articulate with the MKS posterior stabilizing (PS) tibial insert (K112285) or any condylar constrained tibial components. The MRKS box profile is thicker than the MKS femoral component to accommodate increased bone loss. The MRKS tibial component consists of two parts to be assembled at the time of surgery: a tibial baseplate and an ultracongruent (PCL substituting) tibial insert. The baseplate is manufactured from cast cobalt chrome alloy and is designed with an identical locking mechanism as the MKS tibial baseplate (K112285). The baseplate is offered in seven sizes (0-6) and is designed to accommodate the MRKS ultracongruent insert when used with the MRKS femoral component or the MKS PS tibial insert (K112285) when used with the MKS PS femoral component (Ki 12285). The MRKS tibial baseplate is thicker than the MKS baseplate to accommodate increased bone loss. The MRKS insert is manufactured from ultra-high molecular weight polyethylene (UHMWPE) and is designed with an identical locking mechanism, thickness, and size range as the MKS PS insert. The MRKS accessory components are manufactured from Titanium alloy. The stems are available in three lengths (80, 110, and 150mm) and seven diameters (10-22mm). They employ a male 12/14 Morse taper for attachment to the CRKS femoral component or tibial baseplate. The taper plug is available in one size and is intended for use when a stem is not desired. The taper plug employs an identical male taper as the stem. The augments are available in left and right configurations, and are offered in a range of sizes to accommodate all sizes of the MRKS femoral components and tibial baseplates. Femoral augments are split into distal and posterior segments, each available in 5mm thicknesses. Tibial augments are available in 5mm and 10mm thicknesses. The pegs are offered in three sizes (short, medium, and long). Screws are offered in two sizes (short and long). The baseplate plug is offered in one size. The pegs and screws are designed for mechanically attaching the augments to their respective implants. Pegs also aid in stabilizing the implant post-operatively and are designed to fill the distal augments holes of the femoral component and augment holes of the tibial baseplate when augments are not desired. The baseplate plug is designed to fill the baseplate augment holes when pegs and augments are not desired.

The Treasure Bipolar Head is intended for use as follows: - A. Fractures of the proximal femur; - B. Nonunions of proximal femoral neck fractures; - C. Aseptic necrosis of the femoral head; - D. Osteo-rheumatoid and post-traumatic arthritis of the hip with minimal distortion of the acetabulum; - E. Salvage of failed total hip arthroplasty. The Treasure Bipolar Head is intended for cementless use. The Treasure Bipolar Head is intended for use with the Helicon Hip System.

The TGM Medical, Inc. Treasure Bipolar Head consists of a bipolar femoral head component, locking ring, and a bipolar insert component. The Treasure Bipolar Head is available either fully preassembled, or with the bipolar femoral head and locking ring preassembled and the insert separate. The bipolar femoral head component is manufactured from cobalt chrome alloy (CoCrMo, ASTM F75, ASTM F799, or ASTM F1537). The bipolar head has a highly polished spherical outer surface with a cylindrical bored internal diameter which accepts the polyethylene bipolar insert. The bipolar insert component and locking ring are manufactured from ultra-high molecular weight polyethylene (UHMWPE, ASTM F648). The bipolar insert and locking ring are designed for use with the appropriate size bipolar head component.

The ZENITH Hip System is designed for total hip arthroplasty and is intended to be used with compatible components (femoral heads and acetabular cups) of the Helicon Hip System. The indications for use are: - A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. - B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. - C. Proximal femoral fractures. - D. Avascular necrosis of the femoral head. - E. Non-union of proximal femoral neck fractures. - F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities. The un-coated stem in the ZENITH Hip System is indicated for cemented use while the porous coated stem is indicated for non-cemented use.

The ZENITH Hip System (ZHS) offers a proximally porous and nonporous femoral stem component each compatible with all femoral heads, acetabular components, and cancellous bone screws of the Helicon Hip System (HHS). The porous ZHS stems are manufactured from forged Titanium (Ti) alloy, and employ a porous-coating made from commercially pure Ti (CPTi) beads. The nonporous ZHS stems are manufactured from forged cobalt chrome (CoCr) alloy. The porous Ti stem is a straight, collarless design available in 6 sizes ranging from 10 to 15mm. The nonporous CoCr stem is a straight, collared design available in 8 sizes ranging from 8 to 15mm. Both stems feature a neck-shaft angle of 128°, a 12/14 Morse taper trunnion, neck relief, and a cylindrical fluted shaft. A distal centralizer manufactured from polymethylmethacrylate (PMMA) is available for cemented applications of the CoCr stem. The ZHS also includes 36mm femoral heads and acetabular cups. The heads are manufactured from forged or wrought CoCr alloy. The 36mm inserts are manufactured from conventional UHMWPE. The heads are highly polished and are available in four neck offsets (-5mm, Neutral, +5mm, +10mm). The heads incorporate an identical female 12/14 Morse taper used on all predicate HHS CoCr heads. The 36mm inserts are compatible with predicate HHS acetabular shells ranging in size from 56 to 68mm. Refer to the compatibility table (new Attachment 1 of the September 12, 2012 Al response/Supplement 1 ). The 36mm inserts are offered in neutral or 10 degree hooded configurations. Hooded inserts include an X-ray marker manufactured from wrought Ti alloy. The 36mm heads and mating inserts are also compatible with the Helicon Hip System.

The MILESTONE Knee System Primary Knee is designed as a system and is not intended for substitution of components from other systems. - A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis. - B. Failed osteotomy or unicompartmental replacements. - C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists. All MILESTONE Knee components are intended for cemented use only.

The MILESTONE Knee System (MKS) is a primary, fixed-bearing, total knee system designed to replicate the natural anatomy of the knee in order to restore knee function. It was developed to preserve and utilize healthy ligamentous structures, and to restore stability to the knee. The MKS incorporates femoral, tibial, and patellar components and all associated instrumentation needed for implantation. The femoral and tibial components are provided in left and right configurations. The femoral component is made from CoCr and is offered in a posterior stabilizing (PS) configuration. The tibial component comprises an asymmetric tibial baseplate made from CoCr alloy and an asymmetric PS tibial insert made from UHMWPE. The baseplate is designed to maximize metaphyseal bone coverage on the tibia. The baseplate employs a cruciate type keel to enhance implant fixation and torsion resistance. The tibial insert attaches to the baseplate via a mechanical locking mechanism. All MKS metallic components are available in uncoated variants for cemented use. The patellar component is an all-poly round patella made from UHMWPE, also intended for cemented use.