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The Novae® Dual Mobility and Hype® Hip Systems are indicated for total hip replacement, which includes: - · Osteoarthritis, - · Femoral neck fracture, - · Dislocation risk, - · Osteonecrosis of the femoral head, - · Revision procedures where other treatments or devices have failed and if bone reconstruction so permits. Sunfit TH, Novae® E TH, and Coptos TH acetabular cups are intended for press-fit use and Novae® Stick acetabular cup is indicated for cemented use. Hype® SCS, SCC, SCV, SCC mini, and SCLA mini hip stems are intended for press-fit use.

The Novae® Dual Mobility System consists of cemented acetabular shells and a polyethylene liner. Novae® XPEO-E liners are made from highly crosslinked vitamin E stabilized polyethylene and are spherical in geometry for dual mobility articulation. The inner articular surface mates and retains a Biolox® delta ceramic or CoCrMo metal femoral head. The outer articular surface articulates within the highly polished inner diameter of Novae® cementless or cemented cups. Novae® cups are manufactured from stainless steel, with pressfit options coated with titanium and hydroxyapatite (HA). Pegs and cortical bone screws for optional ancillary fixation are made from stainless steel. Hype® press-fit hip stems are compatible with the Novae® Dual Mobility System and Serf CoCrMo and Biolox® delta femoral heads. Hype® press-fit hip stems are made from titanium alloy coated with titanium and HA. The primary purpose of this 510(k) notification is a line extensions to the 510(k) cleared Novae® acetabular cups (K111572) that are compatible with: (1) liner option made from highly crosslinked and vitamin E stabilized polyethylene (XPEO-E), (2) femoral heads made from CoCrMo alloy and Biolox® delta ceramic, and (3) Hype® press-fit hip stems.

BI-MENTUM™ Dual Mobility System is indicated for total hip replacement, which includes: - Osteoarthritis - Femoral neck fracture - Dislocation risk - Osteonecrosis of the femoral head - Revision procedures where other treatments or devices have failed and if bone reconstruction so permits BI-MENTUM™ PressFit Cup, BI-MENTUM™ Plus Cup and BI-MENTUM™ Revision Cup are intended for press-fit use and BI-MENTUMTM Cemented Cup is indicated for cemented use.

The BI-MENTUM™ dual mobility system is composed of a metallic shell fixed in the acetabulum and a polyethylene liner. Cemented metallic shell: BI-MENTUM™ Cemented Cup: the cemented metallic shell is made of stainless steel according to ISO 5832- 1. The outer surface is sandblasted and presents macro-volumes to augment contact between the implant and the cement. The inner surface is highly polished. Cementless metallic shell: The cementless metallic shell is made of stainless steel according to ISO 5832-1 and is coated with a CP titanium and hydroxyapatite plasma spray (double layer coating) on the outer surface and is highly polished on the inner surface. Three cementless metal-backs are available: - BI-MENTUM™ PressFit Cup: this version is available without the pegs and screw, and is a press fit only. - BI-MENTUM™ Plus Cup: it has 3 fixation points (2 divergent pegs towards the pubis and ischium and 1 cortical screw through a flange towards the ilium). - BI-MENTUM™ Revision Cup: it has 5 fixation points (2 divergent pegs towards the pubis and ischium, cortical screws through 2 flanges towards the ilium and 1 foramen hook). Liner: The liner is made of Ultra-High-Molecular-Weight Polyethylene according to ISO 5834-2. The liner is mobile (free) in the metallic shell and retained on the prosthetic femoral head. Liners can be used with Ø22,2 or 28 mm prosthetic femoral heads. Pegs and cortical screws: When applicable, primary fixation can be reinforced by impacted pegs and self-tapping cortical screws made of stainless steel according to ISO 5832-1.

Cl../..X liner for NOVAE® Dual mobility Acetabular Cup is indicated for total hip replacement, which includes: - . Osteoarthritis - . Femoral neck fracture - Dislocation risk ● - Osteonecrosis of the femoral head - . Revision procedures where other treatments or devices have failed and if bone reconstruction so permits SUNFIT TH, NOVAE E TH and COPTOS TH are intended for press-fit use and NOVAE STICK is indicated for cemented use

The Cl../..X liner for NOVAE® Dual Mobility Acetabular Cup is made of cross-linked Ultra-High-Molecular-Weight Polyethylene which meet the strength requirements of the ASTM F648 and the testing listed in the ASTM F2565. The liner is mobile (free) in the NOVAE® metallic shell (clearance K111572) and retained on the prosthetic femoral head. Liners can be used with Ø22.2 or 28 mm prosthetic femoral heads.

NOVAE® Dual mobility Acetabular Cup is indicated for total hip replacement, which includes: - . Osteoarthritis - . Femoral neck fracture - . Dislocation risk - . Osteonecrosis of the femoral head - Revision procedures where other treatments or devices have failed and if bone . reconstruction so permits SUNFIT TH, NOVAE E TH and COPTOS TH are intended for press-fit use and NOVAE STICK is indicated for cemented use.

The NOVAE® Dual Mobility Acetabular Cup is composed of a metallic shell fixed in the acetabulum and a polyethylene liner. Cemented metallic shell: - NOVAE STICK: the cemented metallic shell is made of stainless steel according to ISO 5832-1:2007. The outer surface is sandblasted and presents macro-volumes to augment contact between the implant and the cement. The inner surface is highly polished. Cementless metallic shell: The cementless metallic shell is made of stainless steel according to ISO 5832-1:2007 and is coated with a CP titanium and hydroxyapatite plasma spray (double layer coating) on the outer surface and is highly polished on the inner surface. Three cementless metal-backs are available: - SUNFIT TH: the SUNFIT TH version is available without the pegs and screw, and is a press fit onlv. - NOVAE E TH: the NOVAE E TH has 3 fixation points (2 divergent pegs towards the pubis and ischium and 1 cortical screw through a flange towards the ilium). - COPTOS TH: the COPTOS TH has 5 fixation points (2 divergent pegs towards the pubis and ischium, cortical screws through 2 flanges towards the ilium and 1 foramen hook). Liner: The liner is made of Ultra-High-Molecular-Weight Polyethylene according to ISO 5834-2:2006. The liner is mobile (free) in the metallic shell and retained on the prosthetic femoral head. Liners can be used with Ø22,2 or 28 mm prosthetic femoral heads. Pegs and cortical screws: When applicable, primary fixation can be reinforced by impacted pegs and self tapping cortical screws made of stainless steel according to ISO 5832-1:2007.