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Found 17 results
510(k) Data Aggregation
K Number
K061749Device Name
ECLIPSE TOTAL ANKLE IMPLANT
Manufacturer
KINETIKOS MEDICAL, INC.
Date Cleared
2006-11-22
(154 days)
Product Code
HSN
Regulation Number
888.3110Why did this record match?
Applicant Name (Manufacturer) :
KINETIKOS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Eclipse Total Ankle replacement system is intended for prosthetic replacement of the tibio-talar joint in patients affected with severe rheumatoid, post-traumatic, or degenerative arthritis. It is also intended for revision of prior ankle surgery, and is intended for use with bone cement.
Device Description
The Eclipse Total Ankle implant is intended for use in total ankle joint replacement arthroplasty. The system consists of various size range components to accommodate variations in human ankle anatomy. Materials: -Cobalt Chrome, per ASTM F75, with Titanium Plasma Spray Coating per ASTM 1580 (Tibia Plates / Talar components) -U.H.M.W.Pe., per ASTM 648-00 (Bearing) -Titanium Alloy per ASTM F-136 (Bone screws) Function: The Eclipse Total Ankle system functions as a replacement for the ankle joint.
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K Number
K061465Device Name
KMI CEMENT RESTRICTOR IMPLANT
Manufacturer
KINETIKOS MEDICAL, INC.
Date Cleared
2006-10-05
(132 days)
Product Code
JDK
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
KINETIKOS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KMI Cement Restrictor Implant is intended to be implanted inside the intramedullary canal for use as an absorbable bone cement flow restrictor plug. The safety and effectiveness of this device for use in the spine have not been established.
Device Description
The KMI Cement Restrictor Implant is a flexible, bio-resorbable restrictor designed to provide a quick and effective method of plugging the intramedullary canal with an easy-to-place absorbable bone plug. Based on the size of the canal and reamer used to form the channel, the appropriate size cement restrictor is selected and is guided into the canal to the desired depth. The KMI Cement Restrictors are malleable to take on the irregular shape of the canal, effectively sealing them at the desired friction-fit position. There are a variety of sizes and shapes offered, including cylindrical and cube versions. Each device can be custom shaped either by manual manipulation, by using a scalpel at the time of surgery, or by press-fitting into the canal.
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K Number
K051611Device Name
MBARESORB IMPLANT
Manufacturer
KINETIKOS MEDICAL, INC.
Date Cleared
2005-09-06
(81 days)
Product Code
HWC, MBJ, MJW
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
KINETIKOS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MBAResorb Implant is indicated as an internal support to primary surgical interventions in the treatment of flat foot, providing structural support at minimum during the first three months of healing.
Device Description
The MBAResorb Implant consists of a soft-threaded implant designed to be inserted between the posterior and middle facets of the subtalar joint and corresponding instrumentation to facilitate insertion. The design differs from the predicate Subtalar MBA device only in that the material is reabsorbed into the body.
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K Number
K041461Device Name
KMI DISTAL VOLAR RADIUS PLATE SYSTEM
Manufacturer
KINETIKOS MEDICAL, INC.
Date Cleared
2004-08-16
(75 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
KINETIKOS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KMI Distal Volar Radius Plate is generally indicated for the reduction, stabilization and internal fixation of proximal radius bone fractures and osteotomies involving the distal radius.
Device Description
Description device is intended for use in the reduction, stabilization, and internal Fixation of proximal radial bone fractures. The design incorporates the use of a plate and two sets of bone screw sets that are fixated perpendicular. The implant utilizes 'variable angle locking technology' (VALT) screw locking system which facilitates precise angular positioning of the bone screws relative to the distal volar radius plate.
Materials: Titanium; Ti-6A14V-ELI as per ASTM F136
Function: The system functions to fix proximal radial bone fractures together, thereby facilitating fixation.
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K Number
K032806Device Name
KATALYST RADIAL HEAD IMPLANT
Manufacturer
KINETIKOS MEDICAL, INC.
Date Cleared
2004-04-16
(220 days)
Product Code
KWI
Regulation Number
888.3170Why did this record match?
Applicant Name (Manufacturer) :
KINETIKOS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KMI Katalyst Radial Head Implant is generally indicated for radial head replacement arthroplasty. Use of the implant is contraindicated in those cases where complete avascular necrosis has rendered bone stock inadequate.
Device Description
The KMI Katalyst Radial Head implant is intended for use in radial head replacement arthroplasty. The system consists of modular stem and head components to accommodate variations in human anatomy. The design incorporates an adjustable stem length capability to allow stem length adjustment in-sito.
Materials: -Cobalt Chrome, per ASTM F75 -Stainless Steel BioDur 108 Alloy per ASTM F2229 -UHMWPE per ASTM 648-00
Function: The system functions as a replacement for the proximal radial head.
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K Number
K040356Device Name
KOMPRESSOR SCREW SYSTEM
Manufacturer
KINETIKOS MEDICAL, INC.
Date Cleared
2004-03-01
(17 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
KINETIKOS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The use of the Kompressor compression screw is generally indicated for the reduction and fixation of fractures appropriate for the size of the device. It is indicated for use in the internal fixation of fractures, fusion, and revision. It is also indicated for reconstructive procedures where reduction and fixation of bone fragments is required (e.g. osteotomies). Contraindications would include any conditions which would contraindicate implants in general, including: Infection, Metal sensitivity or allergic reaction to foreign bodies, Any concomitant disease which may compromise the function of the implant, In those cases where avascular necrosis has rendered bone stock inadequate.
Device Description
The Kompressor bone screw implant is a two-piece fixation device intended for use in the reduction, stabilization, and internal fixation of small bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and compress bone segments. The implant is available in a variety of sizes to accommodate various fracture types and sites. Materials: Titanium; Ti-6A14V-ELI per ASTM F136. The system functions to draw bone fractures together, thereby facilitating fixation.
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K Number
K024233Device Name
KOMPRESSOR SCREW SYSTEM
Manufacturer
KINETIKOS MEDICAL, INC.
Date Cleared
2003-02-06
(45 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
KINETIKOS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The use of the Kompressor compresion screw is generally indicated for the reduction and fixation of fractures of the small bones of the hand and wrist, such as the scaphoid. It is indicated for use in the fixation of fractures classified as acute or fresh, as well as cases of non-union where conservative treatment options have failed.
Use of the implant is contraindicated in those cases where complete avascular necrosis has rendered bone stock inadequate.
Device Description
The Kompressor bone screw implant is a two-piece fixation device intended for use in the reduction, stabilization, and internal fixation of bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and fıx fracture fragments, and is available in a variety of sizes to accommodate various fracture types and sites.
Materials: Titanium; Ti-6A14V-ELI as per ASTN F136
Function: The system functions to draw bone fractures together, thereby facilitating fixation.
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K Number
K030037Device Name
UNIVERSAL TOTAL WRIST SYSTEM
Manufacturer
KINETIKOS MEDICAL, INC.
Date Cleared
2003-02-05
(30 days)
Product Code
JWJ
Regulation Number
888.3800Why did this record match?
Applicant Name (Manufacturer) :
KINETIKOS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for intractable pain resulting from traumatic arthritis, osteoarthritis, rheumatoid arthritis, trauma-induced osteoarthritis of the radial/carpal joint. To replace functionality of the joint due to deformity or elements stated above. The Universal Total Wrist is intended for cemented use.
Device Description
The KMI Universal Total Wrist (UTW) System (both predicate and extra small) consists of the following components: the radial implant, the carpal plate implant, the carpal polymer component, and two bone screws. The system will now be offered in 4 (four) sizes: 'extra small', 'small', 'medium' and 'large'), each with 3 (three) matching polymer component sizes, which are available in yarvina thicknesses (height); standard, +1 and + 2, It is constructed of materials that have a long clinical history of proven acceptance and performance. This system is intended for use with cement and will be promoted as such in the UTW Surgical Protocol.
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K Number
K023770Device Name
K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM)
Manufacturer
KINETIKOS MEDICAL, INC.
Date Cleared
2002-12-12
(30 days)
Product Code
KWD
Regulation Number
888.3730Why did this record match?
Applicant Name (Manufacturer) :
KINETIKOS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The K2 Hemi Great Toe Implant System is indicated for use in the treatment of patients with inflammatory arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head, along with the following clinical conditions; Hallux valgus, hallux rigidus and an unstable or painful MTP joint.
Device Description
The KMI Great Toe Implant System consists of 4 (four) sizes of toe implants. The implants will now be plasma coated. It is constructed of materials that have a lona clinical history of proven acceptance and performance. This system is intended for press fit use only and will be promoted as such in the Surgical Protocol 81-0065.
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K Number
K020554Device Name
MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM
Manufacturer
KINETIKOS MEDICAL, INC.
Date Cleared
2002-05-03
(72 days)
Product Code
JWJ
Regulation Number
888.3800Why did this record match?
Applicant Name (Manufacturer) :
KINETIKOS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for intractable pain resulting from traumatic arthritis, rheumatoid arthritis, trauma-induced osteoarthritis of the radial/carpal joint. To replace functionality of the joint due to deformity or elements stated above. Intended for cemented use only.
Device Description
The KMI Universal Total Wrist™ (UTW) System (either predicate or modification) consists of the following components: the radial implant, the carpal plate implant, the carpal polymer component and two bone screws. The system is offered in three sizes (small, medium, and large), with three matching polymer component sizes, which are available in varying thicknesses (standard, +1 mm, +2 mm). It is constructed of materials that have a long clinical history of proven acceptance and performance. This system is intended for use with cement and will be promoted as such in the UTW surgical technique manual.
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