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510(k) Data Aggregation

    K Number
    K230671
    Device Name
    Pitch PaSoft Tissue Reinforcement Device
    Manufacturer
    Xiros Ltd
    Date Cleared
    2023-05-31

    (82 days)

    Product Code
    FTL, OWX
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Xiros Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pitch-Patch Tissue Reinforcement Device is a single use device intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons. The Pitch -Patch Tissue Reinforcement Device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps tendon or other tendons. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the repair.
    Device Description
    The Pitch-Patch is a permanent implantable device for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon. It is constructed from a warp knitted fabric with integral eyelets. It is reinforced around its perimeter and around each eyelet to increase the security of suture attachment. The Pitch-Patch is available in two sizes, to cover different tear sizes without trimming (30 x 20 mm and 35 x 25 mm). It should not be cut to size. The device is supplied sterile, by Gamma Irradiation to an SAL of 10-6. The Pitch-Patch is made from Polyethylene Terephthalate (PET) also referred as polyester. This a non-absorbable material that has a long history of use in the orthopedic market.
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    K Number
    K222978
    Device Name
    Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
    Manufacturer
    Xiros Ltd
    Date Cleared
    2022-12-27

    (90 days)

    Product Code
    QUW, FTL, OWX
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Xiros Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is a single use device intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon and ligament repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the repair.
    Device Description
    The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (Poly-Tape/Infinity-Lock) is a woven tape made from Polyethylene Terephthalate (PET) also referred to as polyester. This a nonabsorbable material that has a long history of use in the orthopedic market. The Poly-Tape/Infinity-Lock is a permanent implantable device for the reinforcement of soft tissues that are repaired by suture or other fixation devices during soft tissue repair surgery.
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    K Number
    K220091
    Device Name
    Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
    Manufacturer
    Xiros Ltd
    Date Cleared
    2022-08-26

    (226 days)

    Product Code
    FTL, OWX
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Xiros Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement device is a single use device intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during soft tissue repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons . The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the bone, provide mechanical strength for the repair.
    Device Description
    The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement device is a woven tape made from Polyethylene Terephthalate (PET) also referred to as polyester. This a nonabsorbable material that has a long history of use in the orthopedic market. These devices are permanent implants for the reinforcement of soft tissues that are repaired by suture or other fixation devices during soft tissue repair surgery.
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    K Number
    K220906
    Device Name
    SECURE-LOCK
    Manufacturer
    Xiros Ltd
    Date Cleared
    2022-07-22

    (115 days)

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

    Xiros Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SECURE-LOCK is indicated for fixation of bone or soft tissue to bone, and is intended as a fixation device, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair such as Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) Repair and Reconstruction.
    Device Description
    The SECURE-LOCK fixation device consists of a sterile and non-absorbable polyester and ultrahigh molecular weight polyethylene blended braid that forms a loop on a titanium alloy button. The button sits on the cortex over the exit to a bone tunnel, suspending the loop inside the tunnel to provide secure, strong fixation for ligament repair and reconstruction. The SECURE-LOCK fixation device is supplied with polyester sutures that are used to assemble and deliver the device.
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    K Number
    K211563
    Device Name
    Pitch-Patchs
    Manufacturer
    Xiros Ltd
    Date Cleared
    2021-08-13

    (85 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Xiros Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pitch-Patch is a single use device intended to be used for reinforcement of the rotator cuff following or during repair by suture or suture anchors, where weakness exists in the soft tissue. The Pitch-Patch is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the repair.
    Device Description
    The Pitch-Patch is a permanent implantable device for reinforcement of rotator cuff tears. It is constructed from a warp knitted fabric with integral eyelets. It is reinforced around its perimeter and around each eyelet to increase the security of suture attachment. The Pitch-Patch is available in two sizes, to cover different tear sizes without trimming (30 x 20 mm and 35 x 25 mm). It should not be cut to size. The device is supplied sterile. The Pitch-Patch is made from Polyethylene Terephthalate (PET) also referred as polyester. This a nonabsorbable material that has a long history of use in the orthopedic market.
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    K Number
    K191053
    Device Name
    Xtreme-Loop
    Manufacturer
    Xiros Ltd
    Date Cleared
    2019-07-17

    (89 days)

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

    Xiros Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XTREME-LOOP is used for fixation of tendons and ligaments during orthopaedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction.
    Device Description
    The XTREME-LOOP fixation device consists of a Ultra High Molecular Weight Polyethylene (UHMWPE) continuous loop captured on a titanium alloy button sits on the exit to a bone tunnel on the cortex, suspending the continuous loop inside the tunnel to provide secure, strong fixation for ligament reconstruction. The XTREME-LOOP fixation device is supplied with sutures that are used to pull the graft assembly into place and then flip the button allowing ligament reconstruction to be performed arthroscopically.
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    K Number
    K180243
    Device Name
    Infinity-Lock Button System
    Manufacturer
    Xiros Ltd
    Date Cleared
    2018-04-03

    (64 days)

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

    Xiros Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infinity-Lock™ Button System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruption and as an adjunct in external and intramedullary fixation systems involving plates. The Infinity-Lock™ Button System is indicated for patients with acromioclavicular separations resulting from disruption to the coracoclavicular ligaments.
    Device Description
    The Infinity-Lock™ Button System comprises a permanent implantable 240 mm Tube-Tape and titanium alloy Button together with a disposable cannulated drill bit and guidewire. A coracoid passer, such as the Xiros CCHook, is also required.
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    K Number
    K171680
    Device Name
    Infinity-Lock 3, Infinity-Lock 5
    Manufacturer
    Xiros Ltd
    Date Cleared
    2017-06-30

    (24 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Xiros Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infinity-Looks are single use devices intended to be used for soft tissue approximation, including Achilles tendon repair in patients with acute rupture of the Achilles tendon.
    Device Description
    The Infinity-Locks are non-absorbable, sterile, poly(ethylene terephthalate) sutures. They are prepared from fibres of high molecular weight, long chain, linear polyesters having recurrent aromatic rings as an integral component. Infinity-Locks differ from USP Sutures in being in the form of woven tapes and in exceeding all USP sizes. The product comprises two sizes of textile implant based on the Neoligaments poly-tape design. The tapes have an integral loop at one end which are used to tie a cowhitch through one end of a ruptured tendon. The tapes have two tails which are then sutured through the separated end (using methods such as the Bunnell technique), thus drawing the two ends together in order to facilitate healing of the tear. One of the tails has a green stripe to aid identification and both taper into a cord to assist with passing through soft tissues.
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    K Number
    K151601
    Device Name
    SECURE-LOOP
    Manufacturer
    XIROS LTD
    Date Cleared
    2015-09-09

    (89 days)

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

    XIROS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SECURE-LOOP is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as anterior cruciate ligament (ACL) reconstruction.
    Device Description
    The SECURE-LOOP fixation device consists of a polyester continuous loop captured on a titanium alloy button. The button sits on the exit to a bone tunnel on the cortex, suspending the continuous loop inside the tunnel to provide secure, strong fixation for ligament reconstruction. The SECURE-LOOP fixation device is supplied with sutures that are used to pull the graft assembly into place and then flip the button allowing ligament reconstruction to be performed arthroscopically.
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