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510(k) Data Aggregation

    K Number
    K093868
    Device Name
    I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM
    Manufacturer
    I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH
    Date Cleared
    2010-08-05

    (231 days)

    Product Code
    HRS, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The I.T.S. LRS Locking Reconstruction System is a titanium implant fracture fixation system for stabilizing fractures in long bones of the distal femur and proximal lateral tibia of all pediatric patients (less than or equal to 21 years old) or adult patient. Indications for Use include distal/proximal shaft fractures, supracondylar fractures, intra-articular fractures, metaphyseal fractures, osteotomies, nonunions and malunions of the distal femur and proximal tibia. The system is not intended for spinal use.
    Device Description
    The I.T.S. LRS (Locking Reconstruction System) consisting of the DFL (Distal Femur Locking) & PTL (Proximal Lateral Tibia Locking) are fracture fixation plating systems for repairing long bone factures located in the distal femur and proximal tibia in the human body. The DFL Plates consist of three plate lengths of 5, 9, & 13 hole pre-contoured shape in a left/right configuration to fit the distal femur and the PTL Plates consist of three plate lengths of 7, 12, & 17 hole precontoured shape in a left/right configuration to fit the proximal lateral tibia. Both plate systems are manufactured from Commercialy Pure (CP) Titanium material to allow for minor intra-operative forming/contouring by the surgeon. The plate design concept offers an extramedullary, internal fixation system, minimal bone contact, and a locked fixed-angle construct using angular stability locking screws into the plate. Both locking and non-locking high strength 6-4 Alloyed Titanium screws in a 5.9mm cancellous and 4.5mm cancellous/cortical sizes are offered. All screws are self-tapping for insertion into bone. The design intent of the aiming guide instrumentation allows the surgeon to prepare percutaneous targeting of screws through 'minimal invasive' stab incisions. This aiming guide instrument ensures that all targeted screws will be properly inserted and locked to the plate. The aiming guide instrumentation is radiolucent to allow offset (90 degree) fluroscopy evaluation in bone fragment reduction of the fracture site and confirmation of screw engagement into the plate. Small holes in the plate allow intermediate 'k-wire bone fracture segment positioning' for reducing and aligning the fracture bone segments while positioning the plate and the introduction of multiple sizes of locking/nonlocking screws as needed for stabilizing the fracture - when using x-ray fluroscopy. All I.T.S. LRS - DFL & PTL plates and screws are processed with a TIODIZE II surface treatment. A full compliment of instrumentation is available for use with the system.
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    K Number
    K080706
    Device Name
    CONNEXX LOCKING TIBIA NAIL
    Manufacturer
    I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH
    Date Cleared
    2008-06-09

    (89 days)

    Product Code
    JDS, HSB, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the I.T.S. CONNEXX Locking Tibia Nail is to stabilize fractures of the proximal and distal tibia and the tibial shaft in a pediatric or adult patient. Indications for use include open and closed tibial shaft fractures; certain pre and post-isthmic fractures, tibial malunions and non-unions, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, metaphyseal and epiphyseal fractures, transverse fractures, oblique fractures, spiral fractures, segmental fractures, comminuted fractures, bone support, and fractures with bone loss.
    Device Description
    The I.T.S. CONNEXX Locking Tibia Nail is a fracture fixation intramedullary rod with locking/nonlocking cross-screw fixation for repairing long bone tibia fractures of a patient. The I.T.S. CONNEXX Locking Tibia Nail System is composed of a cannulated 9mm and 10mm diameter nail in various lengths (255mm to 420mm in 15mm increments) and two styles of cross-screw attachments, a 4.7mm standard cortical screw as a non-locking feature and a 4.7mm Bolt Double Thread as a non-locking feature (two thread diameters on the screw for thread engagement into the proximal and distal cortex of the tibial shaft when inserted). A cannulated 'locking key sleeve' and 'end cap' combination function to firmly fix the above two cross-screw attachments to the 9mm or 10mm nail for 'locking' the cross-screws to the tibia nail - thus making the entire IM rod/cross-screw assembly 'angle-stable locking'. All tibial rods and cross-screws are composed of high strength 6-4 ELI Titanium Alloy to ASTM F-136. A full compliment of instrumentation is available for use with the system.
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    K Number
    K080184
    Device Name
    DISTAL HUMERAL PLATES WITH ANGULAR STABILITY
    Manufacturer
    I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH
    Date Cleared
    2008-03-26

    (61 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The I.T.S. Distal Humeral Plates with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the distal humerus in the elbow of a pediatric or adult patient. Indications for Use include intra-articular fractures, supracondylar fractures, osteotomies, and non-unions of the distal humerus.
    Device Description
    The I.T.S. GmbH Distal Humeral Plates with Angular Stability is a fracture fixation plating system for repairing factures located in the distal area of the humerus in the elbow (in the area of medial and lateral epicondyles of the distal humerus). The Distal Humeral Plates consist of two plate designs as a medial (8 hole) and dorsolateral (5 hole) left and right plate configuration - anatomically pre-contoured to fit the distal humerus human anatomy and manufactured from Commercialy Pure (CP) Titanium material for minor intra-operative forming by the surgeon. The offset opposite location of the plates on the medial and lateral epicondyles provide a girder-like construct for difficult bone fracture reconstruction stability. The added benefit of locking screws within each plate and up to a +- 15° angle position allows a fixed-angle contruct of screw-to-plate and offers angle-flexibility in screw positioning for further optimal fracture stability. Small holes in the plate allow intermediate 'k-wire bone fracture segment positioning' for reducing and aligning the fracture bone segments while positioning the plates and introducing multiple sizes of locking/non-locking screws as needed for stabilizing the fracture(s) - when using optional x-ray fluroscopy. The system offers a 3.5mm locking and non-locking cortical screw and a 4.2mm locking cancellous screw in multiple lengths manufactured from High Strength 6-4 Alloyed Titanium material. All plates and screws are processed with a TIODIZE II surface treatment - which improves the material surface hardness and biocompatibility to adjacent tissues. The low-profile and contoured left and right plate design minimizes soft-tissue irritation for the patient. A full compliment of instrumentation is available for use with the system.
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    K Number
    K063672
    Device Name
    FIBULA PLATE PROLOCK WITH ANGULAR STABILITY
    Manufacturer
    I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH
    Date Cleared
    2007-02-02

    (53 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The I.T.S. Fibula Plate PROlock with Angular Stability is a titanium implant fracture fixation system for repairing bone fractures located from the middle to the distal third of the fibula. Indications for Use include metaphysial and diaphysial fracture fixation of acute fractures, malunions, and non-unions of the distal fibula. Other indications include corrective osteotomy and open and closed fractures. The system is not intended for spinal use.
    Device Description
    The I.T.S. Fibula Plate PROlock with Angular Stability is a low-profile left and right titanium plate in three lengths with various length cortical and/or cancellous locking self-tapping stabilization screws. The fibula plate is made from CP Titanium according to ASTM F 67-00 and the screws are made from 6-4 Alloyed Titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation.
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    K Number
    K063166
    Device Name
    I.T.S. PELVIC RECONSTRUCTION SYSTEM
    Manufacturer
    I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH
    Date Cleared
    2006-12-22

    (65 days)

    Product Code
    HRS, HWC, JDW
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the I.T.S. Pelvic Reconstruction System (PRS) is to stabilize one or more pelvic bone fractures in the 'pelvic ring' area of the pelvis of an adult or pediatric patient which include the use of the following pelvic fracture fixation systems. Indications for use of the I.T.S. PRS Low Profile - Multiple Type - Pelvic Plating System include: 1) Fracture reconstruction of the acetabulum, sacrum, illium, and entire pelvic ring, 2) Revision surgery of pseoduarthroses, non-unions and mal-unions, 3) Ilio-Iliac distance osteosynthesis, 4) Osteotomies, 5) Arthrodesis, 6) Sacroiliac joint dislocations, and 7) Symphysis pubis disruptures Indications for use of the I.T.S. PRS Sacral Rod System include: 1) Fixation of fractures of the posterior pelvis, 2) Fixation of fractures of the posterior iliac spine, 3) Fixation of fractures of the posterior inferior illac spine, 4) Dorsal stabilization of the posterior pelvic ring for unstable pelvic ring injuries, 5) Fixation of sacral fractures, and 6) Fracture dislocations of the sacro-iliac joint Indications for use of the I.T.S. PRS 7.3mm Cannulated SIJ Traction Screw & Washer include fracture fixation of pelvic bone fractures where indicated and for periacetabular osteotomies. The system(s) has not been studied in spinal use, and is not intended for use in vertebral column fracture or fusion procedures.
    Device Description
    The I.T.S. Pelvic Reconstruction System (PRS) encompasses a number of fracture fixation subsystems (multiple pelvic plate designs, sacral threaded rod, and cannulated screw & washer) for facture fixation and reconstruction of pelvic ring fractures in the pelvis. The I.T.S. PRS Low Profile - Multiple Type - Pelvic Plating System consists of the following plate types: 1) A Straight Plate at a 2.5mm thickness with 10 to 14 hole length sizes, 2) A Curved Plate with a 108mm radius at a 2.5mm thickness with 4 to 16 hole length sizes, 3) A Curved Plate with a 88mm radius at a 2.5mm thickness also with 4 to 16 hole length sizes, 4) A Symphysis Plate at a 4.0mm thickness in both a 4 & 6 hole size, 5) A SacroIlliac-Joint (SIJ) L-Shaped Plate at a 2.5mm thickness in a left and right 5 hole size, and 6) A SIJ Closed Plate at a 2.5mm thickness in a 4 hole size. All plate designs are low profile in thickness and made from CP of Cancellous (5.9mm std.compression & 5.9mm Locking screws) and Cortical (4.5mm std.compression screw) screw types and length sizes. All bone screws are pre-drilling and self-tapping in design and manufactured from high strength 6-4 Alloyed Titanium. All components (plates & screws) have a TIODIZE II surface treatment preparation. The I.T.S. PRS Sacral Rod System consists of a threaded pin, wedgeshaped washers, and nut/locknut design with one end of the threaded pin having a trocar point. The assembled unit is used to stabilize ilio-iliac posterior pelvic ring disruption injuries. All components are manufactured from high strength 6-4 Alloyed Titanium material and have the TIODIZE II surface preparation. The I.T.S. PRS 7.3mm Cannulated SIJ Traction Screw & Washer is a pre-drilling, self-tapping, and back-tapping screw design for guided reduction of pelvic bone fractures. Washers (flat & curved) are available for use with the screw. All 7.3mm Cannulated Screws & washers are manufactured from high strength 6-4 Alloyed Titanium and have the TIODIZE II surface preparation.
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    K Number
    K060156
    Device Name
    STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM
    Manufacturer
    I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH
    Date Cleared
    2006-03-20

    (59 days)

    Product Code
    HRS, HTN, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the I.T.S. Straight Plate with Angular Stability is to stabilize an osteotomy or fracture of small bones, long bones, the pelvis and the calcaneus in an adult or pediatric patient. Indications for use include comminuted fractures, supercondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions. And, as well, a fracture or osteotomy of the tibia, fibula, femoral condyle, acetabulum, humerus, ulna, middle hand and middle foot bones: treatment of the calcaneus; hip arthrodesis, and provisional hole fixation. The 3.5mm Cortical and Cancellous Angle Stable Screws used in conjunction with the Straight Plate may be used only on small bones. The intended use of the I.T.S. Screw System is for corrective osteotomy or internal fracture fixation of the patella, pelvis, ankle, and long bones in an adult or pediatric patient. For the 4.0mm Cannulated Cancellous Screw, indications for use are for radial and ulnar fractures, fractures of the proximal/distal humerus and of the patella, and for tendon fixation, maisonneuve injuries and disruption of the syndesmosis with bimalleolar or supermalleolar fractures and the instability of the talus centering. For the 6.5mm Cannulated Cancellous Screw, indications for use are for fractures of the femoral neck, tibiaplateau, of the sacrum and the articular cavity of the hip joint, and the metaphyseal fractures of the distal femur and distal tibia, fixation of the Ileosacral joint, and fusion of the foot and ankle. For the 7.3mm Cannulated Cancellous Screw, indications for use are for fractures of the calcaneus, femoral neck, tibiaplateau, and of the sacrum and the articular cavity of the hip joint, fusion of the foot and ankle, fixation of the Ileosacral joint, and metaphyseal fractures of the distal femur and distal tibia. The system (s) is not intended for spinal use.
    Device Description
    The I.T.S. Straight Plate with Angular Stability is a low-profile 4, 6, or 8 hole plate with various length cortical and/or cancellous self-tapping stabilization locking and/or compression screws. The Straight Plate is made from CP titanium according to ASTM F 67-00 and all screws are made from 6-4 Alloyed Titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation. The I.T.S. Screw System is a group of cannulated fracture fixation screws in various diameters of 4.0mm, 6.5mm, and 7.3mm and lengths. A complement of flat and spherical Washers are available with the system. All screws and washers are made from 6-4 Alloyed Titanium according to ASTM F 136-02 and are surface conditioned with a TIODIZE, Type II preparation.
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    K Number
    K052368
    Device Name
    OLECRANONPLATE WITH ANGULAR STABILITY
    Manufacturer
    I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH
    Date Cleared
    2005-10-17

    (49 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The I.T.S. Olecranonplate with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the proximal ulna (olecranon) in the elbow. Indications for Use include fixation of complex intra- and extra- articular fractures, osteotomies, nonunions, malunions, Type 1, 2, 3, & 4 simple fractures, and Type 5a, 5b, 5c, & 6 complex fractures (comminuted) of the proximal ulna (olecranon).
    Device Description
    The I.T.S. Olecranonplate with Angular Stability is a low-profile universal left and right titanium 8, 10, and 12 hole plate with various length 4.2mm Cancellous self-tapping and head locking stabilization screws. Additional 3.5mm Cortical screws of various lengths are self-tapping and are interchangeable in use to lock the plate to the dorsal shaft of the ulna. The Olecranonplate is made from CP titanium according to ASTM F 67-00 and the screws are made from 6-4 alloyed titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation.
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    K Number
    K051642
    Device Name
    FR.O.H. CALCANEUS REPAIR SYSTEM
    Manufacturer
    I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH
    Date Cleared
    2005-08-22

    (63 days)

    Product Code
    NDF, NDJ
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The I.T.S. FR.O.H. Calcaneus Repair System is a titanium implant fracture fixation system for repairing fractures located in the calcaneus heel bone of the foot. Indications for Use include: Intra and extra-articular fracture(s) of the calcaneus, corrective osteotomy, joint depression, non-displaced and tonque type, severely comminuted fractures, multifragmentary fractures, revision procedures, joint fusion, stabilization and fixation of fresh fractures, reconstruction of the calcaneus bones, and open and closed fractures of the calcaneus. The system can be used in both adult and pediatric patients. This system is not intended for spinal use.
    Device Description
    The I.T.S. FR.O.H. Calcaneus Repair System is a combination of fracture reduction and alignment instrumentation with either calcaneus plate and/or cannulated cancellous screw fixation across calcaneal heel bone fracture site(s). The 15-hole Calcaneus Plate (universal left and right in 2 sizes) is made from CP titanium according to ASTM F 67-00 and corresponding plate locking and self-tapping 3.5 & 4.2mm Cancellous Screws from 6-4 alloyed titanium according to ASTM F 136-02. The fully threaded 7.3mm Cannulated Cancelous Screw is in various lengths from 50 to 90mm in 5mm increment sizes and is also made from 6-4 alloyed titanium according to ASTM F 136-02. All titanium plates and screws are surface conditioned with a TIODIZE, Type II preparation
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    K Number
    K052011
    Device Name
    PILONPLATE WITH ANGULAR STABILITY
    Manufacturer
    I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH
    Date Cleared
    2005-08-10

    (16 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The I.T.S. Pilonplate with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the distal tibia in the leg. Indications for Use include fixation of complex intra- and extra- articular fractures, osteotomies, high medial malleollar fractures, and low boot top type rotational distal extra-articular shaft fractures of the distal tibia.
    Device Description
    The I.T.S. Pilonplate with Angular Stability is a low-profile universal left and right titanium 4, 6, and 8 hole plate with various length 4.2mm Cancellous self-tapping and head locking stabilization screws. Additional 4.5mm Cortical screws of various lengths are self-tapping and secure the Pilonplate to the shaft of the tibia bone. The Pilonplate is made from CP titanium according to ASTM F 67-00 and the screws are made from 6-4 alloyed titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation.
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    K Number
    K051412
    Device Name
    HUMERAL HEAD PLATE WITH ANGULAR STABILITY
    Manufacturer
    I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH
    Date Cleared
    2005-07-11

    (41 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The I.T.S. Humeral Head Plate with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the proximal humerus in the shoulder. Indications for Use include fracture and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
    Device Description
    The I.T.S. Humeral Head Plate with Angular Stability is a low-profile universal left and right titanium 4, 6, and 8 hole plate with various length cancellous self-tapping stabilization screws. The humeral head plate is made from CP titanium according to ASTM F 67-00 and the screws are made from 6-4 alloyed titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation.
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