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    K Number
    K111678
    Device Name
    ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS
    Manufacturer
    ORTHO SOLUTIONS LIMITED
    Date Cleared
    2012-02-07

    (237 days)

    Product Code
    HRS,HWC,JDR
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K022325,K022324,K061808,K100359,K070031,K060746,K964226,K061798,K092670,K050681,K043059,K071479,K082320,K050819,K042583,K103705,K963118,K060026
    Why did this record match?
    Device Name :

    ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the Ortho Solutions Extremity Fixation Implants for Osteosymthesis System of bundled fixation device(s) is to draw two or more aligned small bone fragments together to facilitate healing. The Ortho Solutions Extremity Fixation Implants for Osteosynthesis System is used in adult patients.

    The Ortho Solutions Foot Plating System (FPS) is indicated for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the feet, ankles, and toes skeleton.

    The Ortho Solutions Memo Staple System is indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis. The Memo Staple is also indicated for use in fixation of soft tissue to bone such as anterior cruciate reconstruction.

    The Ortho Solutions Foot Osteotomy System (FOS) is indicated for alignment and stabilization of small bone fractures including: fixation of small bones, such as those in the foot and ankle for treatment of fractures, non-unions, or mal-unions; ligament reconstructions; osteochondritis dissecans; arthrodesis of the foot and ankle; small bone osteotomies, including first metatarsal head osteotomy and metatarsal osteotomies.

    The Ortho Solutions Staples System is indicated for fixation of bone fractures or bone reconstruction. The staples are also indicated for use in fixation of soft tissue to bone.

    The Ortho Solutions Compression Screws System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

    The Ortho Solutions TwistFix™ Snap-Off Screws System is indicated for fixation of bone fractures or for bone reconstruction. Examples include: 1) Fixation of small bone fragments, 2) Weil Osteotomy, 3) Mono-cortical fixation, and 4) Osteotomies and fractures fixation in the foot and hand.

    The Ortho Solutions Extremity Fixation System (EFS) of a low profile head screw is indicated for use in fixation of small bone fractures, nonunions, arthrodesis, and osteotomies of the small bones in the hand or foot.

    The Ortho Solutions Extemity Fixation Implants for Osteosynthesis System is not intended for spinal use.

    Device Description

    The Ortho Solutions Extremity Fixation Implants for Osteosynthesis consists of Predicate Trauma Implant components commonly found with large companies with orthopedic markets in the United States. These 'small bone extremity trauma implant devices' consist of the following categories:

    1. Foot Plating System (FPS)
    2. Memo Staple System
    3. Foot Osteotomy System (FOS)
    4. Staples System
    5. Compression Screws System
    6. TwistFix™ Snap-Off Screws System
    7. Extremity Fixation System (EFS)

    A brief and concise description of each system is enclosed as follows:

    1. Foot Plating System (FPS): The Ortho Solutions Foot Plating System (FPS) is designed to address a variety of indications in rearfoot, midfoot, and forefoot reconstuctive fixation surgery. The overall system is composed of a smaller 2.7mm and larger 3.5mm locking/nonlocking plating category of system(s). The 2.7mm system of three(3) plate designs consisting of a Universal Locking Plate 2.7 (ULP-2.7), a MetaTarso Phalangeal Plate (MPT), and a Open Wedge Locking Plate (OWL) - all utilized with either a locking or non-locking 2.7mm Screw in various lengths. The 3.5mm system of seven(7) plate designs consisting of a Universal Locking Plate 3.5 (ULP-3.5), a Lapidus Plate(LAP), a Arthrodesis Wedge Plate (AWP), a Rearfoot Reconstuction Plate (RRP), a Tarsal Fusion Plate (TFP), a Calcaneal Step Plate (CSP), and a Calcaneal Locking Plate (CLP) - all utilized with either a locking or non-locking 3.5mm Screw in various lengths. A 3.5mm Cannulated Screw System in various lengths with Washer is also included in the FPS System. Associated instrumentation such as trial plates, disposable drills & wires/guide wires, and ancillary instrumentation is available. All plates, screws, and washer are manufactured from high strength 6-4 Alloyed Titanium to ASTM F136. All plates, screws and washer are offered 'sterile' to the customer.

    2. Memo Staple System: The Ortho Solutions Memo Staple System consists of four(4) staple sizes (at 10mm, 12mm, 20mm, and 25mm) manufactured from a Nickel-Titanium Nitinol material according to ASTM 2063 for foot reconstruction fixation/arthrodesis procedures. Only the room temperature superelastic properties of the nitinol material with the use of 'spreader/expander instrumention' is utilized in the surgical procedure to enact compression. Associated instrumentation such as templates, spreaders, expanders, guides, disposable drills and ancillary instrumentation is available. All Memo Staples are offered 'sterile' to the customer.

    3. Foot Osteotomy System (FOS): The Ortho Solutions Foot Osteotomy System(FOS) consists of a Nail Plate/Staple with Screws in various lengths and Cannulated/Non-cannulated Compression Screws in various lengths for performing metatarsal/phalangeal osteotomies and/or small bone fixation reconstruction. All components are manufactured from CP Titanium to ASTM F67 and high strength 6-4 Alloyed Titanium to ASTM F136. Associated instrumentation such as guide wires, disposable drills and ancillary instrumentation is available. All staple plate/screw and compression screws are offered 'sterile' to the customer.

    4. Staples System: The Ortho Solutions Staples System is composed of a Varisation Staple (smooth), a Compression Varisation Staple (tapered and ribbed), a Compression Staple (in 11mm, 12mm, 13mm, 15mm, and 20mm and width sizes), and a Blount Staple (in 22mm and width sizes) that are barbed/ribbed, angled, and smooth staple components manufactured from high strength 316LVM surgical grade stainless steel material according to ASTM F138. These staple systems are utilized for fixation of bone fractures or bone reconstruction and for fixation of soft tissues. A 'spreader instrument' is used to deform the compression staple diamond shape for bone compression fixation. Associated instrumentation such as spreaders and expanders with disposable drills and ancillary instrumentation is available. All Staples are offered 'sterile' to the customer.

    5. Compression Screws System: The Ortho Solutions Compression Screws System consists of Cannulated Meta Compression and Cannulated Compression Screws in various lengths at a diameter of 3.0mm and is used for bone reconstruction in small bone extremities. All compression screws are manufactured from high strength alloyed Titanium to ASTM F136. Associated instumentation such as guide wires and disposable drills and ancillary instrumentation is available. All compression screws are offered 'sterile' to the customer.

    6. TwistFix™ Snap-Off Screws System: The Ortho Solutions TwistFix™ Snap-Off Screws System comes in a 2.0mm and 2.5mm diameter with various lengths. All TwistFix™ Snap-Off Screws are manufactured from high strength 6-4 Alloyed Titanium to ASTM F136 and CP Titanium to ASTM F67 and are utilized in metatarsal/ phalangeal small bone fixation/osteotomy procedures. Ancillary instrumentaion with disposable drills is available. All TwistFix™ Snap-Off screws are offered 'sterile' to the customer.

    7. Extremity Fixation System (EFS): The Ortho Solutions Extremity Fixation System (EFS) consists of various Cannulated and Non-cannulated Flat Head low profile Fixation Screws in diameter sizes of 2.0mm, 2.4mm, 2.7mm, and 3.5mm, in various lengths and are manufactured from high strength 6-4 Alloyed Titanium material to ASTM F136. These flat head screws allow for a low-profile head-on the cortex bone surface for reduction of tissue irritation. Associated instrumentation such as guide wires, disposable drills and ancillary instrumentation is available. All Flat Head Screws are offered 'sterile' to the customer.

    AI/ML Overview

    The provided text is a 510(k) summary for the Ortho Solutions Extremity Fixation Implants for Osteosynthesis and does not contain information about acceptance criteria or a study proving device performance against such criteria.

    The 510(k) summary focuses on establishing "substantial equivalence" to legally marketed predicate devices, meaning the device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness. This process typically relies on comparing the new device's technological characteristics and intended use to existing devices, and often involves engineering tests (e.g., mechanical strength, material biocompatibility) rather than clinical studies that establish "acceptance criteria" and "device performance" in terms of clinical outcomes or diagnostic accuracy.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from this document. The document describes:

    • Device Description: Various orthopedic fixation systems (plates, screws, staples) made of titanium or stainless steel for small bone fixation in extremities.
    • Intended Use: Fixation of small bone fragments, fractures, osteotomies, fusions, and soft tissue in the hand, foot, and ankle.
    • Substantial Equivalence: Listing of predicate devices to which the Ortho Solutions system is considered equivalent.
    • Safety and Effectiveness Summary: A general statement about being safe and effective for use as 'sterile' and for single-use, based on equivalence to predicate devices and presumably non-clinical testing.

    The document does NOT include information on:

    1. Acceptance Criteria and Reported Device Performance (Table): No specific performance metrics or thresholds are defined, nor are results of a study against such criteria presented.
    2. Sample Size and Data Provenance (for test set): There is no mention of a "test set" in the context of clinical or diagnostic performance evaluation. The substantial equivalence is based on device characteristics, materials, and intended use.
    3. Number and Qualifications of Experts for Ground Truth: Not applicable, as there is no ground truth established for a performance study.
    4. Adjudication Method: Not applicable.
    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No such study is mentioned.
    6. Standalone Performance Study: No clinical or diagnostic standalone performance study is described.
    7. Type of Ground Truth Used: Not applicable, as no clinical performance study is detailed.
    8. Sample Size for Training Set: Not applicable, as this is not a machine learning device.
    9. How Ground Truth for Training Set Was Established: Not applicable.
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