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510(k) Data Aggregation
K Number
K962215Device Name
CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER
Manufacturer
U.S. MEDICAL PRODUCTS, INC.
Date Cleared
1996-08-15
(66 days)
Product Code
HWE
Regulation Number
878.4820Why did this record match?
Applicant Name (Manufacturer) :
U.S. MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Consensus® Posterior Stabilized Knee system employs a router device to remove the intercondylar bone from the distal portion of the femur. This bone must be removed to accommodate the spine of the posterior stabilized tibial insert. This procedure occurs after all bone resections of the distal femur have been completed in the traditional manner with the existing Consensus® Knee instruments.
Device Description
A template is placed on the distal femur. This template is made from stainless steel (17-4PH SS @ H900). The template contains a central groove with adequate markings that ensure proper guidance of the router.
The router itself consists of a router bit (17-4PH SS @ H900), the shank of which is encased in a plastic body (Ultem® 4000) that acts as a handle for the surgeon and as a journal bearing for the shaft of the router bit.
The base of the body has a large diametrical flange that rests on the superior surface of the template. This flange acts to stabilize the router against torsional forces created by the router bit. The superior end of the router shank is attached to a standard flexible shaft. A standard Zimmer fitting is integrally machined to the superior side of the flexible shaft in order to accommodate a standard operating room power drill (Stryker, 3M, etc.).
The router body and bit are available in one size. The template is available in three sizes; size 1/2, size 3/4, and size 5/6. This accommodates the range of Consensus® Knee posterior stabilized femoral components.
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K Number
K954818Device Name
CONSENSUS POSTERIOR STABILIZED KNEE
Manufacturer
U.S. MEDICAL PRODUCTS, INC.
Date Cleared
1996-05-22
(215 days)
Product Code
JWH
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
U.S. MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Consensus® Posterior Stabilized Knee is indicated for use in:
- 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis in the absense of the posterior cruciate ligament.
- 2. Failed osteotomy or unicompartmental replacements
- 3. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
Device Description
The Consensus® PS Knee tibial insert component is manufactured from ultra-high molecular weight polyethylene (UHMWPE, ASTM F648), and is designed to articulate with the Consensus® PS femoral component. The insert has a spine on the central eminence which engages the crossbar of the PS femoral component. The spine is positioned so that the crossbar of the PS femoral component engages at approximately 65° flexion. The inferior surface of each component employs dovetail grooves for positive interlocking with the Consensus® Primary Knee tibial baseplate. The design is available in three sizes and each size is available in five thicknesses.
The Consensus® PS Femoral component is made of CoCrMo alloy (ASTM F75). Both the outer articulating surface and the inner box geometry of the Consensus® PS femoral component are identical to the respective surfaces of the Consensus® Primary Knee femoral component. Therefore, the PS femoral component contains the same deepened patella groove as the Consensus® Primary Knee femoral component for increased range of motion, utilizes the same instrumentation as the Consensus® Knee for preparing the distal femur, and employs smooth distal pegs for added Medial/Lateral stability. The Consensus® PS femoral component has a shortened patella groove to accommodate the spine of the Consensus® PS tibial insert. It also contains a stabilizing bar located between the posterior condyles which engages the spine of the Consensus® PS tibial insert at high flexion angles.
The Consensus® Posterior Stabilized Knee System will be provided sterile.
The Consensus® Posterior Stabilized Knee is designed for use with the following Consensus® Total Knee System components:
Consensus® All Poly or metal back Patellar component
Consensus® Porous Titanium Stemmed Tibial Baseplate
Consensus® Nonporous Titanium Stemmed Tibial Baseplate
Consensus® CoCr Stemmed Tibial Baseplate
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K Number
K953443Device Name
CONSENSUS PCL SUBSITUTING TIBIAL INSERT
Manufacturer
U.S. MEDICAL PRODUCTS, INC.
Date Cleared
1996-04-26
(284 days)
Product Code
JWH
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
U.S. MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Consensus® PCL Substituting Tibial Insert is indicated for use in:
- 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
- 2. Failed osteotomy or unicompartmental replacements
- 3. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
Device Description
The Consensus® Knee PCL Substituting Tibial Insert component is manufactured from ultra-high molecular weight polyethylene (ASTM F648). It is an asymmetric cruciate-retaining tibial component and is designed to articulate with the Consensus® Knee primary femoral component. Therefore, it has articulating surface geometry similar to the Consensus® Knee congruent tibial insert component. The inferior surface of each component employs dovetail grooves for positive interlocking with the tibial baseplate. The design is available in three sizes and each size is available in five thicknesses. The Consensus® PCL Substituting Tibial Insert will be provided sterile.
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K Number
K952943Device Name
CONSENSUS ALL POLY TIBIA
Manufacturer
U.S. MEDICAL PRODUCTS, INC.
Date Cleared
1996-04-01
(280 days)
Product Code
JWH
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
U.S. MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Consensus® All Poly Tibia is indicated for use in:
- 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
- 2. Failed osteotomy or unicompartmental replacements
- 3. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
Device Description
The Consensus® Knee All Poly Tibia component is manufactured from ultra-high molecular weight polyethylene (ASTM F648). It is a symmetric cruciate-retaining tibial component and is designed to articulate with the Consensus® Knee primary femoral component. Therefore, it has articulating surface geometry similar to the Consensus® Knee congruent tibial insert component. The inferior surface of each component employs dovetail grooves for macro-cement interdigitation between the implant and the bone. Each component has two titanium X-Ray markers for postoperative evaluation: one placed vertically in the distal end of the stem, and one placed horizontally in the central anterior aspect of the component. The design is available in six sizes and each size is available in five thicknesses. The minimum thickness of polyethylene under the articulating surface is 7.5mm for all sizes. The Consensus® All Poly Tibia will be provided sterile.
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K Number
K960302Device Name
CONSENSUS ACETABULAR SHELL, ALL UHMWPE
Manufacturer
U.S. MEDICAL PRODUCTS, INC.
Date Cleared
1996-04-01
(70 days)
Product Code
JDI
Regulation Number
888.3350Why did this record match?
Applicant Name (Manufacturer) :
U.S. MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CONSENSUS® Acetabular Shell, All UHMWPE is indicated for use in:
1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis and avascular necrosis with a non-acute fracture of the femoral neck.
2. Osteoarthrosis involving femoral and acetabular articular surfaces.
3. Avascular osteonecrosis and/or non-union of acute femoral neck fractures.
4. Fracture-dislocation of the hip.
5. Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists.
Device Description
The Consensus® Acetabular Shell, All UHMWPE is intended for use with the Consensus® Total Hip System as an alternative to the the metal acetabular shell and UHMWPE acetabular insert components in the Consensus® Total Hip System. It is a single use device. The Consensus® Acetabular Shell, All UHMWPE is designed for use with size compatible Consensus® Total Hip System components. The Concensus® Acetabular Shell, All UHMWPE will be provided sterile and will be available in fourteen sizes for 22mm heads (42mm to 68mm increments), in twelve sizes for 26mm heads (46mm to 68mm in 2mm increments), and in eleven sizes for 28mm heads (48-68mm in 2mm increments). The material will be ultra high molecular weight polyethylene (UHMWPE), ASTM F648.
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K Number
K960340Device Name
CONSENSUS APEX DOME HOLE PLUG
Manufacturer
U.S. MEDICAL PRODUCTS, INC.
Date Cleared
1996-03-15
(51 days)
Product Code
JDI
Regulation Number
888.3350Why did this record match?
Applicant Name (Manufacturer) :
U.S. MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CONSENSUS® Apex Dome Hole Plug (PMMA) is indicated for use in:
- 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis and avascular necrosis with a non-acute fracture of the femoral neck.
- 2. Osteoarthrosis involving femoral and acetabular articular surfaces.
- 3. Avascular osteonecrosis and/or non-union of acute femoral neck fractures.
- 4. Fracture-dislocation of the hip.
- 5. Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists.
Device Description
The Consensus® Apex Dome Hole Plug (PMMA) is intended for use with the Consensus® Total Hip System as an addition to the the metal acetabilar shell and UHMWPE acetabular insert components in the Consensus® Total Hip System. It is a single use device. The Consensus® Apex Dome Hole Plug (PMMA) is designed for use with size compatible Consensus® Total Hip System components:
Porous coated Acetabular Shell K922561 SE 07/21/93
Nonporous Acetabular Shell K922561 SE 07/21/93
Acetabular Insert, UHMWPE K922561 SE 07/21/93
The Concensus® Apex Dome Hole Plug (PMMA) will be provided sterile and will be available in one size. The material will be polymethylmethacrylate (PMMA), ASTM F451.
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K Number
K960151Device Name
CONSENSUS 26MM COCRMO FEMORAL HEAD
Manufacturer
U.S. MEDICAL PRODUCTS, INC.
Date Cleared
1996-02-21
(41 days)
Product Code
JDI
Regulation Number
888.3350Why did this record match?
Applicant Name (Manufacturer) :
U.S. MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K960156Device Name
CONSENSUS 32MM COCRMO FEMORAL HEAD
Manufacturer
U.S. MEDICAL PRODUCTS, INC.
Date Cleared
1996-02-21
(41 days)
Product Code
JDI
Regulation Number
888.3350Why did this record match?
Applicant Name (Manufacturer) :
U.S. MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K960339Device Name
CONSENSUS 22MM COCRMO FEMORAL HEAD
Manufacturer
U.S. MEDICAL PRODUCTS, INC.
Date Cleared
1996-02-21
(28 days)
Product Code
JDI
Regulation Number
888.3350Why did this record match?
Applicant Name (Manufacturer) :
U.S. MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K955386Device Name
CONSENSUS ZIRCONIA FEMORAL HEAD
Manufacturer
U.S. MEDICAL PRODUCTS, INC.
Date Cleared
1996-02-20
(90 days)
Product Code
LZO
Regulation Number
888.3353Why did this record match?
Applicant Name (Manufacturer) :
U.S. MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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