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510(k) Data Aggregation

    K Number
    K190385
    Device Name
    CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System
    Manufacturer
    In2Bones USA, LLC
    Date Cleared
    2019-08-08

    (170 days)

    Product Code
    HRS,HWC,JDR,KWH
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K160553,K172975,K152631,K182402,K180377,K181113,K173491,K172300,K170518,K163293,K161426,K153609
    Why did this record match?
    Reference Devices :

    K160553, K172975, K152631

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

    The In2Bones USA LLC, CoLink™ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.

    The In2Bones USA LLC, CoLink™ Afx Plating System is indication and fixation of fractures and osteotomies in the ankle, including tibia and fibula, in both pediatric and adult patients.

    The In2Bones USA LLC, Fracture and Correction System plates and screws are intended to treat fractures, fusions, osteotomies and non-unions of the 5th metatarsal.

    The Fracture and Correction System lag screws are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions of various bones, including humerus, radius, ulna, tibia, calcaneus, fibula, and small bones (metatarsals, and phalanges).

    The In2Bones NeoSpan® Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis.

    The RTS® Flexible 1ST MPJ Implant w/Grommets is intended for use in the treatment of:

    • · Hallux limitus or hallux rigidus
    • Painful rheumatoid arthritis
    • Hallux abducto valgus associated with arthritis
    • · Unstable or painful joint from previous surgery

    The RTS® Lesser MTP Implant is intended for use in the treatment of:

    • · Partial or complete dislocation of the lesser metatarsophalangeal joint
    • · Pain associated with either rheumatoid or osteoarthritis
    • · Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint
    • · Stiffness at the lesser metatarsophalangeal joint associated with joint disease
    • · Hammertoe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state.
    Device Description

    The In2Bones CoLink® Plating System / CoLink® View Plating System is a system of plates and screws and surgical instruments used to treat fracture and reconstruction of the extremities. The CoLink® Afx Plating System is a system of plates and surgical instruments used to treat traumatic fractures and osteotomies of the ankle. The products are made of ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V) and the CoLink® View System has inserts made of ASTM F 2026 Poly Ether Ether Ketone (PEEK).

    The Fracture and Correction System consists of the 5MS® Plate and Screw System and the CoLag® cannulated lag screws used to treat fracture and reconstruction of the bones of the extremities. The products are made of ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6A14V).

    The RTS® Lesser MTP Implant System is a double stem silicone implant which is placed into the intramedullary canals of the first metatarsal and proximal phalangeal bones of the forefoot. The RTS® Flexible 1* MPJ Implant w/Grommets System is a flexible silicone great toe implant. Titanium grommets are also available for use in the first metatarsal (only) if the option is desired by the surgeon. The implant is used in the treatment of arthritis of the metatarsophalangeal joint. The implants are made from silicone elastomer NuSil Med 4755 from NuSil.

    The In2Bones NeoSpan® Compression Staple Implant is a super elastic compression staple made of superelastic Nitinol (ASTM F2063). The devices are available in multiple sizes. The implant is designed to hold bones together until healing occurs.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information needed to answer your request. The document is an FDA 510(k) clearance letter for various orthopedic implant systems. It discusses the substantial equivalence of these devices to previously cleared predicate devices, primarily based on indications, materials, and geometry.

    The "Performance Testing" section states that "MR Testing per ASTM Standards (ASTM F2052, ASTM F2213, ASTM F2182 and ASTM F2119) was conducted on worst case products to cover all In2Bones product families." This refers to testing for Magnetic Resonance (MR) compatibility and labeling, not a study that proves the device meets specific acceptance criteria in a clinical or performance effectiveness context directly comparable to an AI/algorithm-based medical device.

    Therefore, I cannot extract:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Number of experts, their qualifications, or adjudication methods for ground truth.
    4. Information about MRMC studies, human reader improvement, or standalone algorithm performance.
    5. Type of ground truth, training set size, or how its ground truth was established.

    This document focuses on regulatory clearance for traditional medical devices (implants), not AI/ML-based software as a medical device (SaMD) which would typically involve the types of studies and criteria you've requested.

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