Porous Plasma Spray (PPS) Ringloc Acetabular System

  • Model / Serial
    Lot numbers M037210, M037230, M099350, M248780, M684480, M727820 and M900900.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.
  • Product Description
    Ringloc + Acetabular Shell limited hole finned 60 mm Size 25 porous coat, for uncemented use, sterile, REF 16-104160, Biomet Orthopedics, Warsaw, IN. || Intended Use: The Porous Plasma Spray (PPS) Ringloc¿ Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA

26 devices with a similar name

Learn more about the data here

  • Model / Serial
    M582210
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.
  • Product Description
    Ringloc + Acetabular Shell limited hole finned 46 mm Size 22 porous coat, for uncemented use, sterile, REF 16-104146, Biomet Orthopedics, Warsaw, IN. || Intended Use: The Porous Plasma Spray (PPS) Ringloc¿ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflamnmatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.
  • Manufacturer
  • Model / Serial
    M105210, M181710, M211040, M582230, M618540, M618560 and M618570.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.
  • Product Description
    Ringloc + Acetabular Shell limited hole finned 48 mm Size 22 porous coat, for uncemented use, sterile, REF 16-104148, Biomet Orthopedics, Warsaw, IN. || Intended Use: The Porous Plasma Spray (PPS) Ringloc¿ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflamnmatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.
  • Manufacturer
  • Model / Serial
    M011320, M011340, M020960, M105260, M361280, M379570, M379580, M482310, M482330, M482340, M583540, M618580, M618910, M815740, M815750, M857250, M888560, M888590, M971590, M971600 and M971680.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.
  • Product Description
    Ringloc + Acetabular Shell limited hole finned 50 mm Size 23 porous coat, for uncemented use, sterile, REF 16-104150, Biomet Orthopedics, Warsaw, IN. || Intended Use: The Porous Plasma Spray (PPS) Ringloc¿ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflamnmatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.
  • Manufacturer
  • Model / Serial
    Lot numbers M022740, M022750, M134000, M379640, M387770, M387780, M387800, M387810, M423630, M618930, M743160, M888610, M888620 and M988780.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.
  • Product Description
    Ringloc + Acetabular Shell limited hole finned 52 mm Size 23 porous coat, for uncemented use, sterile, REF 16-104152, Biomet Orthopedics, Warsaw, IN. || Intended Use: The Porous Plasma Spray (PPS) Ringloc¿a¿ Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.
  • Manufacturer
  • Model / Serial
    Lot numbers M059630, M065810, M065820, M074220, M082510, M082530, M181820, M387830, M387850, M387870, M423730, M482410, M592100, M592150, M743190, M903070, M903080, M903090, M971770 and M061150.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.
  • Product Description
    Ringloc + Acetabular Shell limited hole finned 54 mm Size 24 porous coat, for uncemented use, sterile, REF 16-104154, Biomet Orthopedics, Warsaw, IN. || Intended Use: The Porous Plasma Spray (PPS) Ringloc¿ Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.
  • Manufacturer
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