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Found 6 results
510(k) Data Aggregation
K Number
K021740Device Name
TOTAL KNEE CEMENTED, SEMI-CONSTRAINED
Manufacturer
DJ ORTHOPEDICS, LLC
Date Cleared
2002-09-23
(118 days)
Product Code
JWH
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
DJ ORTHOPEDICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Active Knee® System is indicated to be used only with bone cement in patients suffering from the following conditions:
- Noninflammatory degenerative joint disease including osteoarthritis, . traumatic arthritis, or avascular necrosis.
- Inflammatory degenerative joint disease including rheumatoid arthritis. ●
- Correction of functional deformity such as varus, valgus, or flexion . deformities.
- Revision procedures where other treatments or devices have failed. .
- . Treatment of fractures that are unmanageable using other techniques.
The device is intended for single use only.
The Active Knee® System is contraindicated for the following conditions:
- Acute or chronic infections, either local or systemic: .
- Severe muscular, nervous or vascular disease endangering the leg; .
- Defective bone structures, which could impede adequate anchoring of the ● implant:
- Patients who are younger than 60 years whose joint disease is such that . good results may be achieved by using other reconstructive procedures such as osteotomy and;
- . All associated diseases which could endanger the function and success of the implant.
Device Description
The Active Knee System is a modular knee system consisting of a femoral component, a standard meniscal insert, an ultracongruent meniscal insert (tibial insert), a patella, and a tibial baseplate.
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K Number
K011354Device Name
HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
Manufacturer
DJ ORTHOPEDICS, LLC
Date Cleared
2001-07-31
(89 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
DJ ORTHOPEDICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K010594Device Name
DJ ORTHOPEDICS POST SCREW
Manufacturer
DJ ORTHOPEDICS, LLC
Date Cleared
2001-05-29
(90 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
DJ ORTHOPEDICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K010595Device Name
DJ ORTHOPEDICS INTERFERENCE SCREW
Manufacturer
DJ ORTHOPEDICS, LLC
Date Cleared
2001-05-08
(69 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
DJ ORTHOPEDICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002829Device Name
DJ ORTHOPEDICS FEMORAL ANCHOR
Manufacturer
DJ ORTHOPEDICS, LLC
Date Cleared
2001-03-26
(196 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
DJ ORTHOPEDICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003960Device Name
DJ ORTHOPEDICS TIBIAL ANCHOR
Manufacturer
DJ ORTHOPEDICS, LLC
Date Cleared
2001-03-21
(90 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
DJ ORTHOPEDICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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