Acetabular Cup

  • Model / Serial
    Product Code: MRA, Catalog Number 140-01-56, Serial Numbers: 4268399 and 4268400, Exp. 2/6/2021.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.
  • Product Description
    Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total hip arthroplasty.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

177 devices with a similar name

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  • Model / Serial
    Part Number 999800746, Size 46, All lots
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide
  • Product Description
    ASR ACETABULAR IMPLANT 46, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System || The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat¿ porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. || The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. || The DePuy ASR TM Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
  • Manufacturer
  • Model / Serial
    Part Number 999800744, Size 44, All lots
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide
  • Product Description
    ASR ACETABULAR IMPLANT 44, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. || The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. || The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. || The DePuy ASR TM Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
  • Manufacturer
  • Model / Serial
    Part Number 999800748, Size 48, All lots
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide
  • Product Description
    ASR ACETABULAR IMPLANT 48, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. || The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat¿ porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. || The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. || The DePuy ASR TM Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
  • Manufacturer
  • Model / Serial
    Part Number 999800750, Size 50, All lots
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide
  • Product Description
    ASR ACETABULAR IMPLANT 50, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System || The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat¿ porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. || The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. || The DePuy ASR TM Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
  • Manufacturer
  • Model / Serial
    Part Number 999800752, Size 52, All lots
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide
  • Product Description
    ASR ACETABULAR IMPLANT 52, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. || The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat¿ porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. || The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. || The DePuy ASR TM Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
  • Manufacturer
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