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510(k) Data Aggregation

    K Number
    K230724
    Device Name
    arcad® 2.0 Duo & Quadro osteosynthesis compressive staples
    Manufacturer
    Novastep
    Date Cleared
    2023-12-04

    (263 days)

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

    Novastep

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    arcad® 2.0 Duo & Quadro osteosynthesis compressive staples are indicated for foot bone fragments osteotomy fixation and joint arthrodesis.
    Device Description
    arcad® 2.0 Duo & Quadro osteosynthesis compressive staple implants with two-leg and four-leg configurations with multiple bridge and leg lengths. The implants are manufactured from nickel-titanium alloy (ASTM F2063). The system is provided as a single-use sterile pack comprising of a bone staple implant ready to implant assembled in open legs position on its dedicated disposable insertor forceps and instruments for implantation. The implant is designed to facilitate bone fusion with Nitinol pseudoelastic behavior.
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    K Number
    K223468
    Device Name
    Nexis® compressive screws
    Manufacturer
    Novastep
    Date Cleared
    2023-08-30

    (286 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Novastep

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Nexis® compressive screws system is a single use device indicated for the fixation, correction or stabilization of bones and bone fragments of the foot and ankle in adult patients. The system is indicated for: Ø5.0mm compressive screw: - Os Calcis and talar fractures - Calcaneus osteotomies - Arthrodesis of the tarsals Ø7.0mm compressive screw: - Ankle arthrodesis - Calcaneus osteotomies
    Device Description
    Nexis® is a range of osteosynthesis compressive single use screws, made of titanium alloy, designed to address foot and ankle indications. These devices are designed for stable fixation and have quick insertion features. They are implantable medical devices intended to be used in orthopedics for foot and ankle surgery. The device is sold sterile. The shelf life is 5 years.
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    K Number
    K192356
    Device Name
    Airlock Centrolock Osteosynthesis Implant System
    Manufacturer
    NOVASTEP
    Date Cleared
    2019-12-14

    (107 days)

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

    NOVASTEP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Airlock® Centrolock® osteosynthesis implant systems are single-use devices intended for fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hands, feet, ankle, fingers and toes. Examples include: - Mono or Bi-Cortical osteotomies in the foot or hand - Distal or Proximal metatarsal or metacarpal osteotomies - Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) - Calcaneus/cuboid arthrodesis - Talar/navicular arthrodesis The system may be used in adult patients.
    Device Description
    Airlock® Centrolock® osteosynthesis implant systems are single-use bone fixation devices intended to be permanently implanted. implant systems are designed with different shapes and are made of Titanium (Alloy Ti-6Al-4V ELI). The system uses either 2mm cortical screws or 2,5mm locking screws. The drill holes are aligned to make sure there is no risk of conflict between the screws. The implant vary essentially through different curvatures and shapes.
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    K Number
    K151277
    Device Name
    Airlock® osteosynthesis plate system
    Manufacturer
    NOVASTEP
    Date Cleared
    2015-08-13

    (91 days)

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

    NOVASTEP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Airlock® osteosynthesis plate systems are indicated for fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system may be used in both adult and pediatric patients.
    Device Description
    Airlock® osteosynthesis plate systems are single-use bone fixation devices intended to be permanently implanted. Plates are designed with different shapes and are made of Titanium (Alloy Ti-6Al-4V ELI). The system uses either 3mm or 3,5mm locking and non-locking screws. The drill hole are aligned to make sure there is no risk of conflict between the screws. The plates vary essentially through different curvatures, lengths, number of holes and shape.
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    K Number
    K143523
    Device Name
    Airlock osteosynthesis plate system
    Manufacturer
    NOVASTEP
    Date Cleared
    2015-04-06

    (115 days)

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

    NOVASTEP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Airlock® osteosynthesis plate systems are indicated for fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system may be used in both adult and pediatric patients.
    Device Description
    Airlock® osteosynthesis plate systems are bone fixation devices intended to be permanently implanted. Plates are designed with different shapes and are made of Titanium (Alloy Ti-6Al-4V ELI). The system uses either 3mm or 3,5mm locking and non-locking screws. The drill hole are aligned to make sure there is no risk of conflict between the screws. The plates vary essentially through different curvatures, lengths, number of holes and shape.
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    K Number
    K143049
    Device Name
    LYNC intramedullary implant
    Manufacturer
    NOVASTEP
    Date Cleared
    2015-02-19

    (119 days)

    Product Code
    HTY
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVASTEP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lync® intramedullary implants are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bone fusion.
    Device Description
    Lync® intramedullary implants are single-use bone fixation devices intended to be permanently implanted. Lync® intramedullary implants are made of unalloyed titanium.
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    K Number
    K143146
    Device Name
    Nexis osteosynthesis snap-off screws
    Manufacturer
    NOVASTEP
    Date Cleared
    2015-02-06

    (95 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVASTEP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nexis® osteosynthesis compressive screws are single use devices indicated for the fixing and stabilizing the elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only.
    Device Description
    Nexis® osteosynthesis snap-off screws are single-use bone fixation devices intended to be permanently implanted. Nexis® osteosynthesis snap-off screws are non canulated snap-off screws made of Titanium (Alloy Ti-6Al-4V ELI). Nexis® osteosynthesis snap-off screws are non canulated snap-off bone screws which allow a permanent compression, thus supporting a secure osseous restoration.
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    K Number
    K143229
    Device Name
    Nexis osteosynthesis compressive screws
    Manufacturer
    NOVASTEP
    Date Cleared
    2015-02-06

    (88 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVASTEP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nexis® osteosynthesis compressive screws are single use devices indicated for the fixing and stabilizing the elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only.
    Device Description
    Nexis® osteosynthesis compressive screws are single-use bone fixation devices intended to be permanently implanted. Nexis® osteosynthesis compressive screws are canulated compressive screws made of Titanium (Alloy Ti-6Al-4V ELI). Nexis® osteosynthesis compressive screws are compressive canulated bone screws which allow a permanent compression, thus supporting a secure osseous restoration.
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