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510(k) Data Aggregation

    K Number
    K233258
    Device Name
    Shadow Knotless All-Suture Anchors
    Manufacturer
    Responsive Arthroscopy LLC
    Date Cleared
    2023-10-23

    (25 days)

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

    Responsive Arthroscopy LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Shadow Knotless All-Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Digital Tendon Transfers. Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Hand/Wrist: Scapholunate Ligament Reconstruction of Collateral Ligaments, Carpal Ligament Reconstruction, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP Joints for all Digits, Digital Tendon Repairs. Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair.
    Device Description
    The Shadow Knotless All-Suture Anchor is a modified version of the Responsive Arthroscopy (RA) Mini Stealth All-Suture Anchors that were previously cleared under K230094. The subject Shadow Knotless device is a suture anchor intended for the fixation of soft tissue to bone. The Shadow device features a knotless, push-in design and is comprised entirely of suture material configured to provide an anchor in bone. The anchor creates a secure fixation point for the reattachment of soft tissue to bone when it is inserted through a pilot hole and deployed against the inserter tip below cortical bone in the desired anatomy. The subject device four longitudinally arranged round bundles that bunch together and expand radially when deployed to achieve fixation. The provided suture passing loop allows the integrated repair suture to be passed through the anchor body when securing the desired soft tissue, while the knotless feature allows the repair suture to be locked in place without tying a knot. The anchors may be delivered arthroscopically using inserters and reusable surgical instruments such as drills, guide tubes, and probes, which are identical to those provided with the predicate Mini Stealth All-Suture Anchors (K230094). The subject Shadow anchors are pre-loaded on disposable inserters and provided sterile via ethylene oxide (EO), while the reusable instruments are non-sterile and are intended to be sterilized by the end user. The subject Shadow device is designed for a 2.1mm diameter pilot hole and is comprised of braided nonabsorbable ultra-high molecular weight polyethylene (UHMWPE). It is provided with an attached USP #1 UHMWPE nonabsorbable repair suture tail and a UHMWPE suture passing loop that are used to facilitate a repair. All subject device materials are identical to those of the predicate Mini Stealth All-Suture Anchors (K230094). The primary differences between the subject and predicate devices (K230094) are the additions of the knotless feature, integrated repair suture tail, and suture passing loop. However, these design characteristics are similar to those found in the predicate RA Wedge Push-In Suture Anchors previously cleared under K190446 and K181076. No other changes are being made to the inserters or other instrumentation that may be used during a procedure.
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    K Number
    K230094
    Device Name
    Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors
    Manufacturer
    Responsive Arthroscopy LLC
    Date Cleared
    2023-08-25

    (225 days)

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

    Responsive Arthroscopy LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Repair. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Digital Tendon Transfers. Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Hand/Wrist: Scapholunate Ligament Reconstruction of Collateral Ligaments, Carpal Ligament Reconstruction, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP Joints for all Digits, Digital Tendon Repairs. Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair.
    Device Description
    The Stealth and Mini Stealth All-Suture Anchors intended for the fixation of soft tissue to bone. The All-Suture Anchors feature a push-in design and are comprised entirely of suture material configured to provide an anchor in bone. The anchors create a secure fixation point for the reattachment of soft tissue to bone when they are inserted through a pilot hole and deployed against the inserter tip below cortical bone in the desired anatomy. The All-Suture Anchors feature four longitudinally arranged round bundles that bunch together and expand radially when deployed to achieve fixation. The All-Suture Anchors may be delivered arthroscopically using inserters and surgical instruments such as drills, guide tubes, and probes. The subject device systems include two anchor sizes, the Stealth All-Suture Anchor which is designed for a 3.0mm diameter pilot hole and the Mini Stealth All-Suture Anchor which is designed for a 2.1mm diameter pilot hole. Both anchor systems are comprised of braided nonabsorbable ultra-high molecular weight polyethylene (UHMWPE) material and are available in a variety of configurations containing one or more working USP #2 sutures or 1.5mm suture tapes to facilitate a repair. The Stealth and Mini Stealth All-Suture Anchors are pre-loaded on disposable inserters and provided sterile via ethylene oxide (EO), while the reusable instruments are non-sterile and are intended to be sterilized by the end user.
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    K Number
    K222763
    Device Name
    Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors
    Manufacturer
    Responsive Arthroscopy LLC
    Date Cleared
    2022-10-13

    (30 days)

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

    Responsive Arthroscopy LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Responsive Arthroscopy Mustang Knotless Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hand/wrist, and elbow in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Report, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicylitis Repair
    Device Description
    The Mustang and Mustang Knotless Suture Anchors are modified versions of the RA Large Screw-in Suture Anchors and the Large Push-In Suture Anchors, respectively, that were previously cleared under K180951. The Mustang and Mustang Knotless Suture Anchors are families of suture anchors intended for the fixation of soft tissue to bone. Both Mustang systems include two diameter sizes of suture anchors made of polyether ether ketone (PEEK) per ASTM F2026 along with repair suture tape, inserters, awls, and taps. Both the Mustang and Mustang Knotless device families include several configurations that differ in anchor diameter and suture offerings to accommodate various procedures and patient anatomies. The Mustang Suture Anchors will be offered in two diameter sizes (4.5 and 5.5mm) and are provided with either two #2 sutures or one 1.5 mm suture tape (4.5mm anchor); or three #2 sutures or two 1.5mm suture tapes (5.5mm anchor). The Mustang Knotless Suture Anchors will be offered in two diameter sizes (4.75 and 5.5mm) and are designed to accept up to six #2 suture tails or two 1.5mm suture tape tails (4.75mm anchor); or up to eight #2 suture tails or four 1.5mm suture tape tails (5.5mm anchor). The Mustang Knotless Suture Anchors also feature a suture pull tab and an auxiliary #0 suture that holds the anchor in place until use. The Mustang and Mustang Knotless Suture Anchors are pre-loaded on disposable inserters and provided sterile via ethylene oxide (EO). The only differences between the subject devices and the predicate devices are considered minor and include modified anchor body geometry, modified anchor body dimensions, increase in the number of sutures or suture tapes compatible with the implants, modified internal locking screw geometry and dimensions, and the addition of vent holes to the anchor bodies. In addition, the subject Mustang Knotless Suture Anchor inserter has been modified slightly to correspond with the anchor changes. No other changes are being made to the inserters or other instrumentation that may be used during a procedure.
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    K Number
    K203121
    Device Name
    Responsive Arthroscopy Thunderbolt System
    Manufacturer
    Responsive Arthroscopy LLC
    Date Cleared
    2021-04-27

    (193 days)

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

    Responsive Arthroscopy LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Responsive Arthroscopy Thunderbolt System is intended for soft tissue to bone fixation for the following indications: Shoulder: Bankart lesion repair, SLAP lesion repairs, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps Tenodesis Foot and Ankle: Medial/lateral repair and reconstruction, Mid-and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair, Ankle Syndesmosis disruptions), and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures Elbow: Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment Knee: ACL/PCL repair/reconstruction, ACL/PCL patellar bone-tendon-bone grafts, Double-Tunnel ACL reconstruction, Extracapsular repair: MCL, LCL, and posterior oblique ligament, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement. Joint capsule closure Hand and Wrist. Collateral ligament repair. Scapholunate ligament reconstruction. Tendon transfers in phalanx. Volar plate reconstruction Hip: Acetabular labral repair
    Device Description
    The Responsive Arthroscopy Thunderbolt System is a knotless system for the fixation of soft tissue to bone. The system includes a suture-button implant assembly made of Ti-6Al-4V ELI per ASTM F136 and ultra high molecular weight polyethylene, an implantable two holed plate made of Ti-6Al-4V EU per ASTM F136, and instrumentation including drills and drivers. The implants and single-use instruments are provided sterile, and the reusable instruments are non-sterile and are to be sterilized by the end user.
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    K Number
    K202569
    Device Name
    Responsive Arthroscopy Interference Screw System
    Manufacturer
    Responsive Arthroscopy LLC
    Date Cleared
    2020-09-23

    (19 days)

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

    Responsive Arthroscopy LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Responsive Arthroscopy Interference Screws are intended to be used for fixation of tissue including ligament, tendon, soft tissue, or bone to bone. Interference fixation with PEEK or Titanium Interference Screws is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate. Specifically, screws are intended for use in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction, Anterior Shoulder Instability Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfers in the Foot and Ankle, Bunionectomy Knee: Anterior Cruciate Ligament Repair, Posterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collament Reconstruction, Lateral Epicondylitis Repair Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal Joint
    Device Description
    The Responsive Arthroscopy Interference Screw System is a family of interference screws for the reattachment and fixation of tissue including ligament, tendon, soft tissue, or bone to bone. The system includes cannulated interference screws in both polyether ether ketone (PEEK) per ASTM F2026 and Ti-6Al-4V ELI titanium alloy per ASTM F136, along with drivers, sizers, reamers, taps, and guide wires for screw insertion. The only design differences in the subject device are regarding interference screw length, cannulation, and driving feature. The screws are available in a variety of sizes to accommodate various procedures and patient anatomies. RA PEEK Interference Screws are offered with diameters from 7-12mm and lengths from 15-35mm. RA Titanium Interference Screws are offered with diameters from 7-10mm and lengths from 20-35mm. The RA Interference Screw System implants are provided sterile. The RA Interference Screw System single-use instruments are provided sterile, and the RA Interference Screw System reusable instruments are non-sterile and are to be sterilized by the end user. All RA Interference Screw implants and single-use instruments are sterilized with ethylene oxide (EO).
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    K Number
    K202153
    Device Name
    Responsive Arthroscopy Suture Anchor System
    Manufacturer
    Responsive Arthroscopy LLC
    Date Cleared
    2020-09-09

    (37 days)

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

    Responsive Arthroscopy LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Responsive Arthroscopy Knotless Push-In Suture Anchors are intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Bunionectomy, Digital Tendon Transfers. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Vastus Medialis Obliquus Advancement, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collament Reconstruction. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair. Hip: Capsular Repair, Acetabular Labral Repair.
    Device Description
    The Responsive Arthroscopy (RA) Knotless Push-In Suture Anchor System is an updated version of the RA Knotless Push-In Suture Anchor System previously cleared under K180951. The RA Knotless Push-In Suture Anchor is intended for fixation of suture (soft tissue) to bone. The system includes a variety of anchors made of polyetheretherketone per ASTM F2026 (PEEK) along with repair suture tape, inserters, drills, broaches, and guides. The only differences in the subject device are regarding suture geometry, anchor body geometry, and internal screw geometry. The RA Knotless Push-In Suture Anchor System anchors are available in a variety of geometries and configurations to accommodate various procedures and patient anatomies. RA Knotless Push-In Suture Anchor System anchors range in diameter from 3.5mm to 4.75mm and are either pre-loaded with or accept #2 suture or 2.5mm suture tape. The RA Knotless Push-In Suture Anchor System anchors are pre-loaded on inserters and provided sterilized with ethylene oxide. The RA Knotless Push-In Suture Anchor System reusable instruments are non-sterile and are to be sterilized by the end user.
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    K Number
    K190446
    Device Name
    Responsive Arthroscopy Wedge Push-In Suture Anchors
    Manufacturer
    Responsive Arthroscopy LLC
    Date Cleared
    2019-03-27

    (30 days)

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

    Responsive Arthroscopy LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Responsive Arthroscopy Wedge Push-In Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valqus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy, Digital Tendon Transfers. Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Vastus Medialis Obliguus Advancement. Patellar Tendon Repair. Posterior Oblique Ligament Repair. Iliotibial Band Tenodesis, Joint Capsule Closure. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collament Reconstruction, Carpal Ligament Reconstruction, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP Joints for all Digits, Digital Tendon Transfers. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair. Hip: Capsular Repair, Acetabular Labral Repair, Gluteus Medius Repair.
    Device Description
    The Responsive Arthroscopy (RA) Wedge Push-In Suture Anchor is a knotless suture anchor for the fixation of soft tissue to bone. The system includes suture anchors made of polyether ether ketone per ASTM F2026 (PEEK) along with repair sutures, passing sutures, inserters, drills, and guide tubes. The suture anchor inserters and instrumentation are available in a variety of geometries and configurations to accommodate various procedures and patient anatomies.
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    K Number
    K181076
    Device Name
    Responsive Arthroscopy Wedge Push-In Suture Anchors
    Manufacturer
    Responsive Arthroscopy LLC
    Date Cleared
    2019-01-18

    (269 days)

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

    Responsive Arthroscopy LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Responsive Arthroscopy Wedge Push-In Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy, Digital Tendon Transfers. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Vastus Medialis Obliquus Advancement, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis, Joint Capsule Closure. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP Joints for all Digits, Digital Tendon Transfers. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondvlitis Repair, Hip: Capsular Repair, Acetabular Labral Repair, Gluteus Medius Repair.
    Device Description
    The Responsive Arthroscopy (RA) Wedge Push-In Suture Anchor is a knotless suture anchor for the fixation of soft tissue to bone. The system includes suture anchors made of polyether ether ketone per ASTM F2026 (PEEK) along with repair sutures, passing sutures, inserters, drills, and guide tubes. The suture anchor inserters and instrumentation are available in a variety of geometries and configurations to accommodate various procedures and patient anatomies.
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    K Number
    K180951
    Device Name
    Responsive Arthroscopy Suture Anchor System
    Manufacturer
    Responsive Arthroscopy LLC
    Date Cleared
    2019-01-03

    (267 days)

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

    Responsive Arthroscopy LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Responsive Arthroscopy Large Screw-In Suture Anchors are intended to fixation of soft tissue to bone in the shoulder, foot/ankle, hand/wrist, and elbow in the following procedures. Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collament Reconstruction. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair. The Responsive Arthroscopy Large Push-In Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hand/wrist, and elbow in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair. The Responsive Arthroscopy Small Push-In Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures. Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Bunionectomy, Digital Tendon Transfers. Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Vastus Medialis Obliquus Advancement, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP Joints for all Digits, Digital Tendon Transfers. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair. Hip: Capsular Repair, Acetabular Labral Repair. The Responsive Arthroscopy Knotless Push-In Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures. Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Bunionectomy, Digital Tendon Transfers. Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Vastus Medialis Obliquus Advancement, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction. Elbow: Bicens Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair. Hip: Capsular Repair, Acetabular Labral Repair,
    Device Description
    The Responsive Arthroscopy (RA) Suture Anchor System is a family of suture anchors for the fixation of soft tissue to bone. The system includes a variety of suture anchors made of polyether ether ketone per ASTM F2026 (PEEK) along with repair sutures, inserters, taps, punches, drills, and quide tubes. The suture anchors are available in a variety of geometries and configurations to accommodate various procedures and patient anatomies. RA Suture Anchors range in diameter from 2.5mm to 5.5mm and are either pre-loaded with or accept #2 suture. The RA Suture Anchor System implants are pre-loaded on inserters and provided sterile, RA Suture Anchor System single-use instruments are provided sterile, and the RA Suture Anchor System reusable instruments are non-sterile and are to be sterilized by the end user. All RA Suture Anchor System implants and single-use instruments are sterilized with ethylene oxide (EO).
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    K Number
    K180573
    Device Name
    Responsive Arthroscopy Interference Screw System
    Manufacturer
    Responsive Arthroscopy LLC
    Date Cleared
    2018-11-23

    (263 days)

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

    Responsive Arthroscopy LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Responsive Arthroscopy Interference Screws are intended to be used for fixation of tissue including ligament, tendon, soft tissue, or bone to bone. Interference fixation with PEEK or Titanium Interference Screws is appropriate for surgeries of the knee, shoulder, elbow, and hand/wrist where the sizes offered are patient appropriate. Specifically, screws are intended for use in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction, Anterior Shoulder Instability Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfers in the Foot and Ankle, Bunionectomy Knee: Anterior Cruciate Ligament Repair, Posterior Cruciate Ligament Repair, 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, Lateral Epicondylitis Repair Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal Joint
    Device Description
    The Responsive Arthroscopy (RA) Interference Screw System is a family of interference screws for the reattachment and fixation of tissue including ligament, tendon, soft tissue, or bone to bone. The system includes cannulated interference screws in both polvether ether ketone (PEEK) per ASTM F2026 and Ti-6AI-4V ELI titanium alloy per ASTM F136, along with drivers, taps, and guide wires for screw insertion. The screws are available in a variety of sizes to accommodate various procedures and patient anatomies. RA PEEK Interference Screws are offered with diameters from 7-12mm and lengths from 20-35mm. RA Titanium Interference Screws are offered with diameters from 7-10mm and lengths from 20-35mm. The RA Interference Screw System implants are provided sterile, and the RA Interference Screw System instruments are non-sterile and are to be sterilized by the end user. The RA PEEK Screws are sterilized with ethylene oxide (EO). The RA Titanium Interference Screws are sterilized with gamma radiation.
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