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510(k) Data Aggregation
K Number
K122883Device Name
EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM
Manufacturer
STELKAST COMPANY
Date Cleared
2013-08-05
(319 days)
Product Code
JWH, OIY
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
STELKAST COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Proven Gen-Flex™ Total Knee System is intended for:
- Total knee replacement due to osteoarthritis. osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems.
- Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
The device is intended for cemented use only.
Device Description
The EXp Tibial Inserts and Patellar Components are made of polyethylene to which Vitamin E has been blended. The tibial inserts are available in "Cruciate Retaining" (CR) and "Posterior Stabilized" (PS) designs. The patellar components are available Single Peg and Three Peg designs. These implants are part of the Proven Gen-Flex™ Total Knee System and will be used in conjunction with a femoral component and tibial baseplate in total knee arthroplasty.
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K Number
K122773Device Name
CROSS-OVER ACETABULAR SHELL & LINER
Manufacturer
STELKAST COMPANY
Date Cleared
2012-10-09
(29 days)
Product Code
OQG, JDI, LPH, LWJ, LZO, MAY, OQH, OQI
Regulation Number
888.3358Why did this record match?
Applicant Name (Manufacturer) :
STELKAST COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cross-Over Acetabular Shell and Liner are intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from:
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 using other techniques.
5. Revision of previously failed total hip Arthroplasty.
The Cross-Over Acetabular Shell and Liner are used as part of the Provident Hip Systems. The components of this hip system are intended for cementless fixation.
Device Description
The Cross-Over Acetabular Shell and Liner will be used as part of a complete total hip system in conjunction with a femoral head and femoral stem in total hip arthroplasty.
The Cross-Over Acetabular Shell is made of titanium alloy with a commercially pure titanium plasma spray coating. The Cross-Over Liner is made of polyethylene blended with Vitamin E. The liner is available in both non-hooded and hooded options.
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K Number
K094035Device Name
EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM
Manufacturer
STELKAST COMPANY
Date Cleared
2011-03-24
(449 days)
Product Code
OQG, JDI, LPH, LWJ, LZO, MAY, OQH, OQI
Regulation Number
888.3358Why did this record match?
Applicant Name (Manufacturer) :
STELKAST COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EXp Acetabular Shell Liner is intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from:
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 using other techniques.
5. Revision of previously failed total hip Arthroplasty.
Cemented and Uncemented Applications
Device Description
The EXp Acetabular Shell Liner is made of polyethylene to which Vitamin E has been added. It is available in both hooded and non-hooded options. The liner is part of a complete total hip system and will be used in conjunction with an acetabular shell, femoral head and femoral stem in total hip arthroplasty. The femoral heads which are to be mated with the EXp Liner are made of Biolox forte, Biolox Delta, or CoCr alloy.
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K Number
K081458Device Name
PROVEN STEM EXTENDER
Manufacturer
STELKAST COMPANY
Date Cleared
2008-06-06
(14 days)
Product Code
JWH
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
STELKAST COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The StelKast Proven Stem Extenders are intended for use with compatible components of the Proven Knee System for the following indications:
1. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems;
2. Revision of failed previous reconstructions where sufficient bone stock and soft integrity are present; and
3. Cemented use only.
Device Description
Not Found
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K Number
K063211Device Name
PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT
Manufacturer
STELKAST COMPANY
Date Cleared
2007-01-18
(87 days)
Product Code
JWH
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
STELKAST COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- 1. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems.
- 2. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
- 3. For cemented use only.
Device Description
Not Found
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K Number
K051976Device Name
PROVEN REVISION MODULAR TIBIAL TRAY
Manufacturer
STELKAST COMPANY
Date Cleared
2005-10-17
(88 days)
Product Code
JWH
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
STELKAST COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The StelKast Proven Revision Modular Tibial Tray is intended for cemented use only in total knee replacement with the following indications:
1. osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems;
2. revision of failed previous reconstructions where sufficient bone stock and soft integrity are present.
Device Description
Not Found
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K Number
K033944Device Name
STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD
Manufacturer
STELKAST COMPANY
Date Cleared
2004-03-12
(84 days)
Product Code
LZO
Regulation Number
888.3353Why did this record match?
Applicant Name (Manufacturer) :
STELKAST COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 32mm Modular Ceramic Femoral Head is a single use device used for reconstruction of the articulating surface of the femoral head portion of the hip that is severely disabled and/or very painful resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or fracture of the femoral head.
Device Description
StelKast 32mm Modular Ceramic Femoral Head
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K Number
K032824Device Name
STELKAST UNICONDYLAR KNEE SYSTEM
Manufacturer
STELKAST COMPANY
Date Cleared
2003-11-13
(64 days)
Product Code
HSX
Regulation Number
888.3520Why did this record match?
Applicant Name (Manufacturer) :
STELKAST COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- 1. Moderate joint impairment from painful arthritis (rheumatoid, osteo and/or posttraumatic).
- 2. Revision of a failed unicompartmental knee implant or other procedure.
- 3. Alternative to tibial osteotomy in patients with unicompartmental arthritis.
Device Description
StelKast Unicondylar Knee System
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K Number
K031901Device Name
PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT
Manufacturer
STELKAST COMPANY
Date Cleared
2003-10-10
(112 days)
Product Code
JWH
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
STELKAST COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.
2. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
3. For cemented use only.
Device Description
Stelkast Proven Cemented, Semi-Constrained Total Knee System
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K Number
K032110Device Name
PROCLASS PRESS FIT HIP STEM
Manufacturer
STELKAST COMPANY
Date Cleared
2003-09-22
(75 days)
Product Code
LWJ, LZO
Regulation Number
888.3360Why did this record match?
Applicant Name (Manufacturer) :
STELKAST COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. The ProClass Press Fit Hip Stem is a single use, cementless device used for reconstruction of the articulating surface of the femur portion of the hip that is severely disabled and/or very painful resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or fracture of the femoral head provided there is sufficient sound bone to seat the prosthesis.
2. The stem can be used for primary hip implant or for hip revision of a failed implant.
3. The stem can be used for congenital defects that will allow adequate function of the system.
Device Description
ProClass Press Fit Hip Stem is a single use, cementless device.
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