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510(k) Data Aggregation

    K Number
    K221787
    Device Name
    Auxein's DHS/DCS Plate System
    Manufacturer
    Auxein Medical Private Limited
    Date Cleared
    2023-11-30

    (527 days)

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

    Auxein Medical Private Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DHS/DCS Plate System is intended for use in treating fractures of femoral head (Dynamic Hip Plates) and condylar part of the femur (Dynamic Condylar Plates). Specific indications, which are dependent on the angle of the plate, include: 130°-135°: fractures of the trochanter region, simple and multifragmentary pertrochanteric, intertrochanteric. 95°: distal and intercondylar fractures of the femur.
    Device Description
    The Auxein's DHS/DCS Plate System offers a variety of treatment options depending on the fracture site and the patient. The DHS/DCS Plate System is composed of plates, compression screw and bone screws. The devices are made from either Stainless Steel as per ASTM F138-19 or Titanium alloy as per ASTM F136-13(2021)e1. These implants will be available either in sterile or non-sterile state. Note- Non sterile products have to be sterilized before use. The system is indicated for use in skeletally mature patients only. All implants are for single use only.
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    K Number
    K213059
    Device Name
    Tibia and Fibula System
    Manufacturer
    Auxein Medical Private Limited
    Date Cleared
    2023-01-27

    (492 days)

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

    Auxein Medical Private Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wise-Lock Tibia & Fibula System The Wise-Lock Tibia & Fibula System plates are intended for fracture fixations for the plates included in the system as follows: 3.5mm Wise-Lock Medial Distal Tibia Plate: Medial distal tibia plates are indicated for treating fractures of the tibia. 3.5mm Wise-Lock Proximal Tibia Plate: 3.5mm Wise-Lock Proximal Tibia Plate indicated for treating fractures of the tibia. 3.5mm Wise-Lock Medial Proximal Tibia Plate: The 3.5mm Wise-Lock Medial Proximal Tibia Plates are indicated to buttress metaphyseal fractures of the medial tibia plateau, split type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia. 3.5mm Wise-Lock Posterior Medial Proximal Tibia Plate: 3.5mm Wise-Lock Posterior Medial Proximal Tibia Plates are indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of fractures of the proximal, distal, and metaphyseal areas of the tibia. 3.5mm Wise-Lock Anterolateral Distal Tibia Plate: 3.5mm Wise-Lock Anterolateral Distal Tibia Plate indicated for treating fractures of the tibia. 3.5mm Wise-Lock Medial Distal Tibia Plate, Without Tab: The 3.5mm Wise-Lock Medial Distal Tibia Plate, Without Tab is indicated for fixation of complex intra-and extraarticular fractures and osteotomies of the distal tibia. 3.5mm Wise-Lock Low Profile Medial Distal Tibia Plate, Without Tab: The 3.5mm Wise-Lock Low Profile Medial Distal Tibia Plate, Without Tab is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia. 3.5mm Wise-Lock Lateral Distal Fibula Plate: The 3.5mm Wise-Lock Lateral Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula. 3.5mm Wise-Lock Metaphyseal Plate For Medial Distal Tibia: The 3.5mm Wise-Lock Metaphyseal Plate For Medial Distal Tibia is indicated for fractures, and non-unions of the metaphyseal and diaphyseal region of the distal fibula. 3.5mm Wise-Lock Pilon Plate: The 3.5mm Wise-Lock Pilon Plate is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia. 3.5mm Wise-Lock Pilon Plate, Cruciform: 3.5mm Wise-Lock Pilon Plate, Cruciform is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia. 3.5mm Wise-Lock Z-type Distal Medial Tibial Plate: The 3.5mm Wise-Lock Z-type Distal Medial Tibial Plate is indicated for temporary internal fixation of osteotomies and fractures, including: Comminuted fractures Supracondylar fractures Intra-articular and extra-articular condylar fractures Non-unions, and Malunions 3.5mm Wise-Lock Z-type Proximal Lateral Tibial Plate: The 3.5mm Wise-Lock Z-type Proximal Lateral Tibial Plate is intended for fixation of fractures and osteotomies involving the tibia. The plate is indicated for the the follow: Treatment of non-unions, malunions and fractures of the proximal tibia, including simple, comminuted lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and fractures with associated shaft fractures. To buttress Metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial split fractures with associated depressions and split of depression fractures of the medial tibia plateau. The fixation of fractures of the distal tibia including, but not limited to, ankle fractures, intra articular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures. 4.5/5.0mm Wise-Lock Proximal Lateral Tibia Plate: The 4.5/5.0mm Wise-Lock Proximal Lateral Tibia Plate is indicated for treatment of nonunions, tibial osteotomies (4.5mm plate only), and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures. 4.5/5.0mm Wise-Lock Medial Proximal Tibia Plate: The 4.5/5.0mm Wise-Lock Medial Proximal Tibia Plates are indicated to buttress metaphyseal fractures of the medial tibia plateau, split type fractures of the medial tibia plateau, medial split fractures with associated deplit or depression fractures of the medial tibia plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia. The 4.5mm version may also be used for fixation of nonunions and malunions of the medial proximal tibia shaft, as well as opening and closing wedge tibial osteotomies. 4.5/5.0mm Wise-Lock Proximal Tibia Plate: 4.5/5.0mm Wise-Lock Proximal Tibia Plate is indicated for treatment of non-unions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. AV-Wise Lock Ankle System The AV-Wise Lock Ankle System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused. Indications for plates included in the system are as follows: Medial and Anteromedial Distal Tibia Plates are indicated for fixation of osteotomies, nonunions, nalunions, and replantations of bones and bone fragments of the diaphyseal regions of the distal tibia, Distal Tibia T Plates and Distal Tibia L Plates are indicated to buttress partial articular fragments of the distal tibia, and Lateral Distal Fibula Plates are indicated for fixation of osteotomies, malunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula. AV-Wise Lock Proximal Tibia Plates The AV-Wise Lock Proximal Tibia Plates are indicated to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused including: simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures. Plates can also be used for treatment of nonunions, malunions, tibial osteotomies.
    Device Description
    The Tibia and Fibula System consists of three types of bone Plates system i.e. Wise-Lock Tibia & Fibula Plates, AV-Wise Lock Ankle Plates, AV-Wise Lock Proximal Tibia Plate and screws for implantation in the tibia and fibula bone to treat tibia and fibula bone fractures. The bone plates are available in Stainless steel and Titanium material and also in left and right directional configuration. There are 16 types of bone plates in Wise-lock tibia and fibula bone plates in AV-Wise Lock Ankle bone plates and 2 bone plates in AV-Wise Lock Proximal Tibia bone plate system. There are 25 types of bone screws associated with these bone plates. These implants are sold in both non-sterile and sterile conditions. Note- Non sterile products have to be sterilized before use. The system is indicated for use in adult patients only. All implants are for single use only.
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    K Number
    K213110
    Device Name
    AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor
    Manufacturer
    Auxein Medical Private Limited
    Date Cleared
    2022-12-16

    (448 days)

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

    Auxein Medical Private Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor The AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor are indicated for attachment of soft tissue to bone. This product is intended for the following indications: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction; Hip: Capsular Repair, Acetabular Labral Repair. 2. AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor The AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor are indicated for attachment of soft tissue to bone. This product is intended for the following indications: Shoulder: Rotator Cuff Repair, Acromicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair. Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.
    Device Description
    The AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor and AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor are non-absorbable threaded suture anchor manufactured in PEEK Material. Generally, it is indicated for the attachment of soft tissue to the bone. The anchor comes preloaded on a disposable inserter assembly and is intended for fixation of size 2 suture to bone. The suture options may include needles to facilitate suture passage through tissue. AUXILOCK® PEEK OPTIMA Screw-In Suture anchor is a fully threaded suture anchor featuring dual threads to maximize cortical and cancellous fixation. AUXILOCK® PEEK OPTIMA Screw-In Suture anchor has a flat tip to protect the sutures and to facilitate the insertion. The anchor is particularly suitable for repairing rotator cuff and associated pathologies. AUXILOCK® PEEK OPTIMA Screw-In Suture anchor is available in diameter of 4.5, 5.5 and 6.5mm. This anchor is available with two or three BioBraid suture. The anchors are also available with needles which are ideal for mini-open rotator cuff repair procedures. AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchors are fully threaded knotless anchors. These anchors are designed to be used with sutures or tapes for rotator cuff repair employing the 'bridge' technique. Moreover, the 'knotless' technique consists of passing sutures or tapes of the medial row anchors through the tissue. They are finally inserted into the bone socket once they're loaded through the Rotador anchor eyelet. This technique eliminates possible complications caused by knots compared to other conventional anchors. The anchor is available in 4.75, 5.5 and 6.25mm diameter with PEEK OPTIMA anchor body and eyelet. These implants are sold in sterile conditions (Ethylene Oxide Sterilization). The system is indicated for use in adult patients only. All implants are for single use only. The AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor and AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor consists of Peek OPTIMA (Grade LT1) as per ASTM F2026-17 implantable Class II, Anchors, UHMWPE (Ultra-High Molecular Weight Polyethylene) Suture as per ASTM F2848-17.
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    K Number
    K213018
    Device Name
    Auxilock GFS Mini, GFS II Large, and GFS Ultimate
    Manufacturer
    Auxein Medical Private Limited
    Date Cleared
    2022-11-18

    (424 days)

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

    Auxein Medical Private Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Auxilock GFS Mini, GFS II Large, GFS Ultimate Mini and GFS Ultimate Large are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
    Device Description
    The Auxilock GFS Mini, GFS II Large & GFS Ultimate are a range of devices design for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. Each device is made from a medical grade titanium alloy, Ti-6Al-4V ELI, grade 5 as per ASTM F136 and also includes an UHMWPE polyblend suture component as per ASTM F2848-17. These implants are sold in sterile conditions (Ethylene Oxide Sterilization). The system is indicated for use in adult patients only. All implants are for single use only.
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    K Number
    K213108
    Device Name
    Humerus & Ulna System
    Manufacturer
    Auxein Medical Private Limited
    Date Cleared
    2022-11-04

    (406 days)

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

    Auxein Medical Private Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Specific Indications: 1. 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate is intended for treating of Intraarticular Fracture of the distal humerus, Supracondylar fractures of the distal humerus and Non-unions of the distal humerus. 2. 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate with Lateral Support 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate with Lateral Support is intended for treating of Intraarticular fractures of the distal humerus, Supracondylar fractures of the distal humerus and Non-unions of the distal humerus. 3. 2.7/3.5mm Wise-Lock Dorsolateral Medial Distal Humerus Plate 2.7/3.5mm Wise-Lock Dorsolateral Medial Distal Humerus Plate are indicated for treating of Intraarticular fractures of the distal humerus, Supracondylar fractures of the distal humerus and Non-unions of the distal humerus. 4. 3.5mm Wise-Lock Extra-Articular Distal Humerus Plate 3.5mm Wise-Lock Extra-Articular Distal Humerus Plate are indicated for fractures of the distal humerus. 5. PHEELOS-3.5mm Wise-Lock Proximal Humerus Plate, Short PHEELOS Short Indications - · Dislocated two-, three-, and four-fragment fractures of the proximal humerus - · Pseudarthroses in the proximal humerus - · Osteotomies in the proximal humerus 6. PHEELOS-3.5mm Wise-Lock Proximal Humerus Plate, Long • As for PHEELOS Short, but for fractures extending to the shaft or without medial support. 7. 3.5mm Wise-Lock Proximal Humerus Plate The 3.5mm Wise-Lock Proximal Humerus Plate is intended for fractures and fracture dislocations, and nonunions of the proximal humerus. 8. 3.5mm Wise-Lock Periarticular Proximal Humerus Plate 3.5mm Wise-Lock Periarticular Proximal Humerus Plate are indicated for fracture dislocations, osteotomies, and nonunions of the proximal humerus. 9. 3.5mm Wise-Lock Olecranon Plate 3.5mm Wise-Lock Olecranon Plate is indicated for fixation of fractures and non-unions of the olecranon. 10. 3.5mm Wise-Lock Hook Plate 3.5mm Wise-Lock Hook Plate is indicated for fractures, osteotomies of small bones including the ulna, radius, tibia and fibula. 11. 2.7mm Wise-Lock Screw, Self-Tapping (Hex Head) This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury. 12. 3.5mm Wise-Lock Screw, Self-Tapping (Hex Head) This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury. 13. 3.5mm Wise-Lock Screw, Self-Drilling, (Hex Head) This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury. 14. 3.5mm Wise-Lock Cancellous Screw, Full Thread, Self-Tapping, (Hex Head) This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury. 15. 3.5mm Wise-Lock Cancellous Screw, Short Thread, Self-Tapping, (Hex Head) This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury. 16. 3.5mm Cortical Screw, Self-Tapping, (Hex Head) This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury. 17. 4.0mm Cancellous Screw, Short Thread This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury. 18. 4.0mm Cancellous Screw, Full Thread This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury. 19. 2.7mm Cortical Screw, Self-Tapping, (Hex Head) This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
    Device Description
    The Humerus and Ulna System consists of various types of bone plates, Screws for implantation in the humerus and ulna bone to treat humerus and ulna bone fractures. The Humerus and Ulna System consists of medial and postero-lateral distal humerus plates of various lengths and 2.7 mm locking screws. The plates are pre-contoured to match the anatomy of the distal humerus with a limited contact low profile design. The plate features locking compression holes which accept 2.4, 3.5, & 4.0 mm cortex screws, 2.4, 2.7 & 3.5 mm locking screws, and 4.0 mm cancellous screws. The System is available in Stainless Steel and Titanium. These implants are sold in both non-sterile and sterile conditions. Note- Non sterile products have to be sterilized before use. The system is indicated for use in adult patients only. All implants are for single use only. The humerus and Ulna System contains several plates and each plate has its intended uses.
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    K Number
    K213014
    Device Name
    Varixis Elbow System
    Manufacturer
    Auxein Medical Private Limited
    Date Cleared
    2022-10-03

    (378 days)

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

    Auxein Medical Private Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Auxein's Varixis Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, malunions and non-unions of the distal humerus. Olecranon and Proximal ulna plates are indicated for fractures, malunions and non-unions of the olecranon and proximal ulna.
    Device Description
    The Auxein Varixis Elbow System contains plates intended to treat fractures of the distal humerus and proximal ulna. A variety of plate configurations are included in the system to allow for fixation of multiple fracture patterns. Specifically, the system includes several plate configurations for fixation of the distal humerus which are intended to be used in a two-plate construct where plates are positioned medially and laterally. Additionally, the system includes plates for fixation of the olecranon and proximal ulna. Proximal ulna Plates enables the surgeon to address the specific biomechanical requirements of each fracture pattern while minimizing irritations of the adjacent soft tissue. These implants are sold in both non-sterile and sterile conditions. Note- Non sterile products have to be sterilized before use. All implants are for single use only.
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    K Number
    K213109
    Device Name
    Auxilock Draw Tight Suture-Based Anchor
    Manufacturer
    Auxein Medical Private Limited
    Date Cleared
    2022-08-22

    (332 days)

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

    Auxein Medical Private Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Auxilock Draw Tight Suture-Based Anchor is indicated for attachment of soft tissue to bone. This product is intended for the following indications: Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, Superior Labrum, Anterior to Posterior Lesion Repair. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair. Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Triangular Fibrocartilage Complex Tear.
    Device Description
    AUXILOCK® Draw tight anchor is made with UHMWPE suture anchor body and PEEK OPTIMA eyelet tip. The Auxilock Draw Tight Anchors are designed for use in attachment of soft tissue to bone. The construct of the Draw Tight Anchors is such that when inserted into the bone and deployed via the included suture, a suture ball is created in the prepared socket that provides the necessary fixation. The Draw Tight Anchors are designed to accommodate both sliding and fixed sutures to be used for soft tissue fixation. The anchor is designed to deliver efficiency and promote ease of use. The anchor can be used for rotator cuff repair surgeries. The AUXILOCK® Draw tight suture based anchor provides a small footprint and also asserts subcortical fixation for anchor insertion. The Draw tight anchor is available in 1.8mm and 3.2mm diameter with various combination of BioBraid and suture tapes. The drill guide and anchor driver combination is well-designed to improve the performance and reliability. The Auxilock Draw Tight Suture-Based Anchor consists of the following types of implants: - AUXILOCK® 1.8mm Draw Tight Suture-Based Anchor with One #2 BioBraid: White/Blue . - AUXILOCK® 1.8mm Draw Tight Suture-Based Anchor with One 1.6mm Suture Tape: ● White/Blue - AUXILOCK® 3.2mm Draw Tight Suture-Based Anchor with Two #2 BioBraid: White/Blue & ● White/Black - AUXILOCK® 3.2mm Draw Tight Suture-Based Anchor with One #2 BioBraid And One 1.6mm Suture tape: White/Black & White/Blue The Auxilock Suture is a dyed or non-dyed braided suture construct made of UHMWPE. The proposed suture is braided flat with round ends, and is available in precut lengths in straight and loop configurations, and with or without needles. Suture ends are stiffened with cyanoacrylate. The Suture constructs meet USP standards for suture. The Suture is available in straight and loop configurations; and sizes #2 for suture, and 1.6mm (width) for tape. AUXILOCK® BioBraid Suture AUXILOCK® BioBraid Sutures are braided sterile sutures prepared from Ultra High Molecular Weight Polyethylene (UHMWPE). Sutures are non-absorbable and do not impose any significant changes in tensile strength retention known to occur in vivo. BioBraid sutures are available in a variety of colour combinations for easy suture management in complicated repairs. Suture color additives The UHMWPE sutures when made up of tracers can be with blue polypropylene (pigment ß-Cuphthalocyanine blue) or polyamide black (pigment hematein). The color additive FD&C Blue 2, color additive Black logwood and color additive phtalocyanine are according to FDA and it is approved for use in medical applications (§74.3102 - FDA), (§73.1410 –FDA) and (§74.3045 – FDA) respectively. AUXILOCK® BioBraid Suture Tape AUXILOCK® BioBraid Suture Tape made from UHMPWE has a width of 1.6mm. The suture tape design accommodates the tape in the centre with a suture on the either sides of the tape. These implants are sold in sterile conditions (EO Sterilization). The system is indicated for use in adult patients only. All implants are for single use only. Surgical instrumentation is included in Auxilock Draw Tight Suture-Based Anchor to allow the placement and attachment of the Anchors with bone. Various drill, anchor driver, Awl, Threading device, Tray, Containers and other components are included with the Auxilock Draw Tight Suture-Based Anchor. These Instruments are made from Stainless steel (SS 304) Material.
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    K Number
    K213104
    Device Name
    Auxilock Titanium Screw-In Suture Anchor
    Manufacturer
    Auxein Medical Private Limited
    Date Cleared
    2022-07-29

    (308 days)

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

    Auxein Medical Private Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Auxilock Titanium Screw-In Suture Anchor is intended to be used with #2 Biobraid suture with white, blue, black colors for use for the reattachment of soft tissue to bone for the following indications: Shoulder: Bankart lesion repairs, SLAP lesion repairs, Acromiolavicular separation repairs, Rotator cuff tear repairs, Capsular shift or Capsutolabral reconstructions, Biceps tenodesis, and Deltoid Repairs, Anterior Shoulder Instability Repair. Foot and Ankle: Hallux valgus reconstruction, Medial or Lateral instability repairs/reconstructions, Achilles tendon repair/reconstructions, Mid-foot reconstruction, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy. Elbow, Wrist and Hand: Scapholunate ligament reconstruction, Unar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment, Tennis elbow repair. Knee: Extra-capsular repairs: Medial collateral ligament repair. Lateral ligament repair. Posterior oblique ligament. Iliotibial band tenodesis, Patellar tendon repair - Vastus medialis obliquous advancement. Hip: Capsular repair, Acetabular labral repair.
    Device Description
    The Titanium Screw-In Suture Anchor is a threaded, tapered fastener for use in attachment of soft tissue to bone. The self-tapping AUXILOCK® Titanium screw-in suture anchor is mostly used as a medial row anchor in rotator cuff repair surgery, Bankart or SLAP surgeries. It is recommended for use in small and large-joint repairs without the need for tapping or drilling. AUXILOCK® Titanium screw-in anchors are available in diameter of 2.8mm, 3.5mm, 5.0mm and 6.5mm. The anchor design incorporates a cancellous thread with a tiny core diameter to maximize pull-out strength in cancellous or osteoporotic bone. The AUXILOCK® Titanium screw-in anchor is designed for ultimate mechanical properties (pull-out strength, tensile strength, etc.) and ease-of-use. The anchor design incorporates a cortical thread with a small core diameter to maximize pull-out strength in a cortical or hard bone. The drill guide and drill bit are provided in the instrument set for the accurate placement of the anchor. It in turn minimizes the anchor slippage or breakage during the surgery. All of the Auxein's Non-Absorbable Suture Anchors are provided sterile, for single use only. All Non-Absorbable Suture Anchors are preassembled onto an inserter, sized appropriately to accommodate the indicated procedures. Auxein's Non-Absorbable Suture Anchors come in various configurations, including: with attached non-absorbable suture(s). In certain configurations, the Non-Absorbable Suture Anchors are packaged with a guide and awl. All configurations of the Non-Absorbable Suture Anchors are identical to the identified predicate devices. The device is made from a Titanium alloy, Ti-6Al-4V (ASTM F136) as per grade 5. Note: The #2 Biobraid Suture is not to be used as a stand-alone. It should be used only with the assembled implant. These implants are sold in sterile conditions (Ethylene Oxide Sterilization). The system is indicated for use in adult patients only. All implants are for single use only.
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    K Number
    K211324
    Device Name
    2.4mm Distal Radius System
    Manufacturer
    Auxein Medical Private Limited
    Date Cleared
    2022-03-14

    (318 days)

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

    Auxein Medical Private Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    2.4mm Wise-Lock Distal Radius System: 2.4mm Wise-Lock Distal Radius System are used for displaced extra-articular distal radius fractures and corrective osteotomies of the distal radius. 2.4mm Wise-Lock Proximal Radius System: 2.4mm Wise-Lock Proximal Radius System are used for extra-articular fractures of Proximal radius and multifragmented radial neck fractures. 2.4mm Variable Angle Distal Radius System: 2.4mm Variable Angle Distal Radius System are used for displaced extra-articular and intra-articular distal radius fractures and corrective osteotomies of the distal radius.
    Device Description
    The 2.4mm Radius System consists of various types of bone plates, screws for implantation in the radius bone to treat the radius bone fracture.
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    K Number
    K210792
    Device Name
    Auxein Nailing System
    Manufacturer
    Auxein Medical Private Limited
    Date Cleared
    2021-08-25

    (163 days)

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

    Auxein Medical Private Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Name: Auxein Nailing System are categorized to the following system: 1. Expert Tibia Nailing System 2. Expert Femoral Nailing System 3. Gamma Nailing System 4. AJAX Advance nailing system 5. Elastic Nailing System 6. Humeral Nailing System 7. Retrograde Nailing System INDICATION FOR USE: 1. AUXEIN Brand of Expert Tibia Nailing System- consists of variety of Bone nails and bone screws. Expert Tibia Nail System is intended to stabilize fractures of the proximal and distal tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non- unions. 2. AUXEIN Brand of Expert Femoral Nailing System -is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions. 3. AUXEIN Brand of Gamma Nailing System -The Gamma Nail with Anti -Rotation Screw is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, including non-union and tumor resections. The Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas, impending pathological fractures, long subtrochanteric fractures, ipsilateral fractures, proximal or distal non-unions, malunions, revision procedures and tumor resections. 4. AUXEIN Brand of AJAX Advance Nailing System, end cap and screws is intended to treat stable and unstable proximal femoral fracture including Pertrochanteric fractures and High sub trochanteric fractures and combination of these fractures. 5. The AUXEIN MEDICAL's Elastic Intramedullary Nail System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the important. This includes upper extremity fractures in all patients and lower extremity fractures in children above the age of 6 years and any patient below 65 kg. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures. 6. AUXEIN Brand of Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures. 7. AUXEIN Brand of Retrograde Nailing System This nails are indicated for simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of long bones being treated.
    Device Description
    An intramedullary rod, also known as an intramedullary nail (IM nail) or inter-locking nail is a metal rod forced into the medullary cavity of a bone. IM nails have long been used to treat fractures of long bones of the body. The device is made from a Titanium alloy, Ti-6Al-4V ELI (ASTM F136). Auxein Brand of Expert Tibia Nail system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps & locking bolts of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 8mm to 12mm; the length varies from 255mm. The screw implants are in corresponding diameter of 4.4mm & 4.8mm diameters with lengths varying as per the requirements and minimum length: 24mm to maximum length 90mm. Auxein Brand of Expert Femoral Nail system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps, locking screw & Anti-rotation screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones.The diameter of the nails varies from 9mm to 13mm; the length varies from 320mm to 440mm.The screw implants are in corresponding diameter of 4.8mm, 6.4mm & 10.5mm diameters with lengths varying as per the requirements and minimum length: 25mm to maximum length 130mm. Auxein Brand of Ga-mma Nailing system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps, Inner screw, locking bolts, Anti-rotation screw & Cephalic screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 9mm to 13mm; the length varies from 180mm. The screw implants are in corresponding diameter of 4.8mm, 6.4mm & 10.5mm diameters with lengths varying as per the requirements and minimum length: 26mm to maximum length 120mm. Auxein Brand of Humeral Nailing system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps, locking bolt, compression screw, and proximal screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 6mm to 9mm; the length varies from 180mm to 320mm. The screw implants are in corresponding diameter of 3.5mm & 4.5mm diameters with lengths varying as per the requirements and minimum length: 20mm to maximum length 70mm. Auxein Brand of AJAX Advance Nailing system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps, locking bolts, Cephalic screw, Ajax Blade, and inner screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 9mm to 12mm: the length varies from 170mm to 420mm.The screw implants are in corresponding diameter of 4.9mm & 10.5mm diameters with lengths varying as per the requirements and minimum length: 26mm to maximum length 120mm. Auxein Brand of Elastic Nailing system consists of various shapes and sizes of sterile nails featuring end caps of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 1.5mm to 4.0mm; the total length of 440mm. The end caps are in corresponding diameter ranges from 1.5mm to 4.0mm diameters with length of 14mm & 25mm. Auxein Brand of Retrograde Nailing system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps & locking bolts of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 9.5 to 12mm; the length varies from 180mm to 360mm. The screw implants are in corresponding diameter of 5.0mm diameters with lengths varying as per the requirements and minimum length: 32mm to maximum length 80mm. Auxein Nailing System covered same products as of covered in K192003. In this addition Auxein Nailing System is offering sterile version of the nailing devices. The device is made from a Titanium alloy, Ti-6Al-4V ELI (ASTM F136). However, we are adding a new device i.e. Ajax Blade in this submission. The associated Instruments with the newly added device are tabulated below. 1. Inner Screwdriver, Hex 4.0mm 2. Inner Screw Holder, Hex 4.0mm 3. Container for AJAX Cephalic Screw Instrument Set These implants will be supplied in Sterile State (Gamma Irradiation) Only.
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