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510(k) Data Aggregation
K Number
K972760Device Name
LINK, ACETABULAR REVISION MESH CUP
Manufacturer
LINK AMERICA, INC.
Date Cleared
1997-10-22
(90 days)
Product Code
JDJ
Regulation Number
878.3300Why did this record match?
Product Code :
JDJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cases of acetabular erosion or protrusio are not un-common. These problems are usually caused by a prior, failed acetabular implant, or a trauma induced fracture, or as a result of progressive joint disease. The surgical re-construction of the acetabular it is necessary to restore the floor or defect in the natural acetabular joint cavity. Using the mesh cup or mesh sheet as a scaffold. This creates a sound foundation or base for the definitive load bearing acetabular cup replacement devise:
Device Description
Link Acetabular Mesh Cup and Sheet
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K Number
K970957Device Name
OSTEONICS RESTORATION ACETABULAR RING
Manufacturer
OSTEONICS CORP.
Date Cleared
1997-06-03
(78 days)
Product Code
JDJ
Regulation Number
878.3300Why did this record match?
Product Code :
JDJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indications for the use of the Osteonics® Restoration Acetabular Rings, in keeping with those of other legally marketed Osteonics acetabular components, are as follows:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid . arthritis, post-traumatic arthritis or late stage avascular necrosis.
- . Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques . are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques o as indicated by deficiencies of the acetabulum.
- . Class II cavitary or protrusio defects.
Device Description
The Osteonics Restoration Acetabular Rings are single use components which are intended for placement within the acetabulum, and which are intended to provide an articulating surface for corresponding, Osteonics' femoral head/stem components. Each Osteonics" Restoration Acetabular Ring is assembled from two separate components: an Osteonics" Restoration Acetabular Shell and a predicate Osteonics Omnifit "Cup Insert, Osteonics "Concentric Polyethylene Acetabular Cup, or Osteonics Flanged Polyethylene Acetabular Cup.
The bodies of the Osteonics" Omnifit" Cup Insert, Osteonics" Concentric Polyethylene Acetabular Cup, and Osteonics" Flanged Polyethylene Acetabular Cup are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The Osteonics Omnifit" Cup Insert, Osteonics Concentric Polyethylene Acetabular Cup, or Osteonics Flanged Polyethylene Acetabular Cup, when used with the Osteonics" Restoration Acetabular Ring, is intended to be affixed to the shell via polymethylmethacrylate (PMMA) bone cement.
The Osteonics" Restoration Acetabular Rings are manufactured from ASTM F-67 Commercially Pure Titanium (CP Ti). The shells are available in a range of outer diameter shell sizes. The Osteonics Restoration Acetabular Ring features a basic spherical geometry, thirteen or sixteen acetabular dome screw holes (depending on the size of the shell), a built up 20° superior lip, an inferiorly located acetabular notch hook, and satin-finished interior and exterior surfaces.
Bone screws placed through the dome and/or lip of the acetabular shell are used to secure the Osteonics" Restoration Acetabular Ring within the prepared acetabulum. The shells are designed to allow some of the bone cement (used to fix the polyethylene liner to the shell) to be extruded through any unoccupied acetabular dome screw holes. In addition to traditional acetabular dome screws, and in order to further enhance the potential for initial and long term stable shell fixation despite small bony defects, the Osteonics" Restoration Acetabular Ring employs an inferior hook and a superior lip. The inferior hook is crimped around the acetabular notch. The superior lip of the shell covers the superior rim of the acetabular cavity and can be secured to the acetabulum with 6.5mm cancellous bone screws.
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K Number
K963940Device Name
EXETER MESH
Manufacturer
HOWMEDICA, INC.
Date Cleared
1997-02-13
(135 days)
Product Code
JDJ
Regulation Number
878.3300Why did this record match?
Product Code :
JDJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Exeter Mesh is intended to be used to reinforce bone when additional strengthening and support is required.
Device Description
The Exeter Mesh is available in four (4) styles to fit a variety of anatomical requirements. The mesh is intended to be either cemented in place or affixed with screws. Screws are provided that are 3.5mm in diameter and range in length from 10mm to 35mm.
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K Number
K962541Device Name
REFLECTION ACETABULAR REINFORCEMENT RINGS
Manufacturer
SMITH & NEPHEW RICHARDS, INC.
Date Cleared
1996-09-17
(81 days)
Product Code
JDJ
Regulation Number
878.3300Why did this record match?
Product Code :
JDJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Reflection Acetabular Reinforcement Ring System is indicated as follows: rheumatoid arthritis, avascular necrosis, femoral neck fractures, osteomyelitis, fracture-dislocation of the hip, and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection. Indications also include osteoarthritis, traumatic arthritis, slipped capita epiphysis, fused hip, and diastrophic variant. Reflection Acetabular Reinforcement Rings are intended to be used in primary and revision surgeries where the acetabulum has the deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and / or protrusion as a result of the indications listed previously. The device is for single use.
Device Description
The Reflection Acetabular Reinforcement Ring is a device intended to address acetabular defects. The rings are manufactured from titanium in a variety of sizes to accommodate the needs of patients.
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K Number
K962007Device Name
PROTRUSION CAGES
Manufacturer
DEPUY, INC.
Date Cleared
1996-08-01
(71 days)
Product Code
JDJ
Regulation Number
878.3300Why did this record match?
Product Code :
JDJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DePuy Protrusio Cage is intended to be used to reinforce a deficient or weakened medial acetabular wall to prevent the protrusion of an acetabular cup prosthesis into the abdominal cavity and may be indicated for use in cases involving acetabular revision procedures, severe osteoporosis, Protrusio Acetabuli, or a shallow acetabular roof.
Device Description
The DePuy Protrusio Cage is a rimmed metal shell with multiple holes and ischial "wings". It is intended to reinforce weak acetabula by transferring stress away from the medial wall to the stronger acetabular rim. The wings and rim of the cage can be fixed to solid bone using Titanium bone screws. The reinforcement provided by the Protrusio cage allows improved fixation of an acetabular cup prosthesis, which can be fixed inside the Protrusio cage using bone cement. The DePuy Protrusio cage is available in diameters of 52, 56 and 60mm in right and left configurations. The Titanium bone screws have a diameter of 6.5mm and are available in lengths of 20, 25, 30, 35, 40, 45, 50, 55 and 60mm.
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