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The PINNACLETM Constrained Acetabular Liner is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history or prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability and for whom all other options of constrained acetabular components have been considered. The PINNACLETM Constrained Acetabular Liner is indicated for use with the PINNACLETM Acetabular Cup in cementless application.

The PINNACLE™ Constrained Acetabular Liner is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The liner is manufactured from ultra-high molecular weight polyethylene (UHMWPE), which locks into a porous coated, hemispherical outer shell component manufactured from titanium alloy (Ti-Al6-V4). The liner component articulates with a metal femoral head of an appropriate diameter. The PINNACLE™ Constrained Acetabular Liner mechanically constrains the femoral head within the inner diameters of the liner by providing greater than 180 degrees femoral head capture combined with a titanium constraining ring which fits over the opening diameter of the liner. The UHMWPE liner is held in the metal shell by means of a titanium locking ring. The PINNACLE™ Constrained Acetabular Liners are UHMWPE acetabular cup liners that are available in a lateralized neutral or lateralized face-changing orientation. The liners have inner diameters compatible with standard metal femoral heads sized 28, 32, and 36mm, as well as larger diameter unipolar, Self-Centering (bipolar) and Modular M femoral heads sized 40 and 44mm. The outer diameters (OD) are geometrically the same as other Pinnacle Acetabular Liners, in a 48mm-76mm size range offering.

The R3™ Constrained Liner Acetabular System is an uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained Liner is intended for single use only.

Subject of this Traditional premarket notification is the addition of new liner sizes to the Smith & Nephew R3" Constrained Liner Acetabular System. The R3 Constrained Liner Acetabular System currently consists of the R3 Constrained Liner offered in sizes of 52mm to 66/70mm cleared via premarket notification K111635. The proposed devices are additional sizes to the R3 Constrained Liners that were previously cleared. The proposed devices will be offered in sizes of 48mm, 50mm, 72-74mm, and 76-80mm, and will be marketed as part of the R3 Constrained Liner Acetabular System. The new R3 Constrained Liner sizes are line additions to the primary predicate R3 Constrained Liners cleared via premarket notification K111635. The subject devices are similar to the primary predicate R3 Constrained Liners in that they are a multipiece acetabular component consisting of a bipolar bearing that articulates with a captured outer polyethylene liner, locking ring, and outer poly support ring. The subject devices and the primary predicate R3 Constrained Liners utilize a tripolar design allowing motion at two interfaces: the femoral head with the bipolar bearing and the bipolar bearing with the outer liner. The subject devices are identical in design to the cleared R3 Constrained Liners, with the exception that they are smaller or larger in overall size. The new R3 Constrained Liner sizes are also similar to the following additional predicates: R3 Constrained Liners (K122139), REFLECTION Constrained Liners (K021803, K033442), R3 XLPE Liners (K113848), and DePuy Self-Centering Hip Prostheses (K033273). The subject devices are also similar to reference predicate Osteonics Constrained Acetabular Inserts (P960047). The subject devices utilize seven components manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE), forged Titanium Alloy (Ti-6Al-4V), and Cobalt Chrome (CoCr).

EXPRT™ Revision Hip System is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.

The EXPRT™ Revision Hip System includes non-porous distal femoral stem implants and nonporous proximal body implants, with bolt, all made from titanium alloy (Ti6Al4V) per ASTM F1472. System specific instrumentation allows the surgeon to prepare the bone to accept the EXPRT™ Revision Hip System implants.

Exprt™ Revision Hip System is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.

The EXPRT™ Revision Hip System includes non-porous distal femoral stem implants and nonporous proximal body implants, with bolt, all made from titanium alloy (Ti6Al4V) per ASTM F1472. System specific instrumentation allows the surgeon to prepare the bone to accept the EXPRT™ Revision Hip System implants.

The R3 Constrained Liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained Liner is intended for single use only.

The R3 Constrained Liners were previously cleared for market via premarket notification K111635. Subject of this premarket notification are minor modifications to the R3 Constrained Liner components, specifically the bipolar shell and inner poly liner. The R3 Constrained Liners are available with inner diameters of 22 and 28mm and outer diameters from 52mm through 66/70mm. The devices are assembled from components that are made of ASTM F75 CoCr, ASTM F90 CoCr, ASTM F1472 Ti-6AI-4V, and ASTM F648 UHMWPE.

The R3 Constrained Liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained Liner is intended for single use only.

The R3 Constrained Liners were previously cleared for market notification K083566. In August of 2010, Smith & Nephew launched a voluntary recall of the devices due to reports of intraoperative distocations .- The subject devices have been modified to address the intraoperative failure mode. Design features have been incorporated into the inner locking and support ring components of the R3 Constrained Liner construct which increase the device's resistance to dislocation under dynamic loading. The R3 Constrained Liners are available with inner diameters of 22 and 28mm and outer diameters from 52mm through 66/70mm. The devices are assembled from components that are made of ASTM F75 CoCr, ASTM F90 CoCr, ASTM F1472 Ti-6Al-4V, and ASTM F648 UHMWPE.

The Longevity IT Constrained Liner is indicated as a component of a total hip prosthesis in primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered.

The Longevity Integrated Taper (IT) Constrained Liner is a modular acetabular shell liner intended to capture the femoral head of a total hip prosthesis to reduce the incidence of joint dislocation. The liners feature integral polyethylene "fingers" reinforced with a modular Tivanium® ring to capture the mating femoral head. The Longevity IT Constrained Liners are intended to mate with Continuum and Trilogy IT acetabular shells.

The R3 Constrained Liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acefabular components have been considered. The R3 Constrained Liner is intended for single use only.

The R3 Constrained Liner and Shell Construct is a multi-piece acetabular component made up of an R3 Shell and the Constrained Liner Constrained Liner Construct includes a bipolar bearing which articulates with a captured outer polyethylene liner, locking ring and outer poly support ring. The R3 Constrained Liner may be used with previously implanted femoral stems, femoral heads and acetabular shells as in a revision case, or it may be used in primary cases and implanted along with a shell, head and stem. The R3 Constrained liner was designed to be used with existing Smith & Nephew hip components. The R3 Constrained Liner should not be used with ceramic femoral heads or skirted femoral heads of any material.

The Trabecular Metal Acetabular Revision System (TMARS) Cemented Constrained Liner is intended to be cemented into a TMARS shell is intended for cementless fixation into the acetabulum. The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss. soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered.

The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is a polyethylene/metal acetabular liner, which, when used with a Trabecular Metal Acctabular Revision Shell (K050937, cleared May 11, 2005), forms the acetabular component of a total bip prosthesis. The device consists of a Longewire highly crosslinked polyethylene liner and a Tivanium " Titanium alloy constraming ring. The liner allows for mechanical capture of the metal fernoral head and greater flexion/extension range of motion than hooded constrained liner designs. Subject acetabular liners are available in mner diameters of 28. 32 and 36mm.

The SPA Porcus Coated Proximal Sleeve components of the S-ROM Total Hip System are indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from theumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonumion of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion. The SPA Porous Coated Proximal Sleeves are intended for cementless use.

The SPA Poeous Coated Peoximal Sleeve is a composent of the S-ROM Total Hip Replacement System. It is a porous coated Titanium femoral component with an elliptical shape that matches the contour of the bone and a stepped exterior to maximize compressive stresses. Fixation of the proximal sleeve to the femur is achieved by biologic fixation via tissue in-growth into the porous onsung.