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The Knotilus+ Biocomposite Knotless Anchor is intended to be used for soft-tissue to bone fixation in the shoulder, foot and ankle, knee, hand and wrist, elbow, and hip in skeletally mature pediatric and adult patients. It is indicated for use in the following procedures: **2.4x11.3mm, 2.9x12.5mm, and 2.9x15.5mm:** - **Shoulder:** Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift, or Capsulolabral Reconstruction - **Foot and Ankle:** Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament and Tendon Repair - **Knee:** Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis - **Hand and Wrist:** Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction - **Elbow:** Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair - **Hip:** Acetabular Labral Repair **2.4x8.9mm:** - **Hip:** Acetabular Labral Repair

The Knotilus+ Biocomposite Knotless Anchors are hard-body, push-in, knotless bone anchors. The subject device is comprised of a poly-ether-ether-ketone (PEEK) eyelet and poly-L-lactide ("PLLA") and beta-tricalcium phosphate ("β-TCP") anchor body, pre-assembled onto a disposable stainless-steel inserter, which enables insertion of the anchor into bone after creation of a pilot hole. The devices are single use, provided sterile, and are packaged in sterile barrier systems (SBS).

The Stryker AlphaVent™ Knotless SP Biocomposite Anchor is intended to be used for soft-tissue to bone fixation in the shoulder, foot and ankle, knee, hand and wrist, elbow, and hip in skeletally mature pediatric and adult patients. It is indicated 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 - **Foot/Ankle:** Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair - **Knee:** Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair, Secondary or Adjunct Fixation for ACL/PCL Reconstruction or Repair, Meniscal Root Repair, MPFL Repair/Reconstruction - **Hand/Wrist:** Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction - **Elbow:** Biceps Tendon Reattachment, Ulnar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair - **Hip:** Capsular Repair, Acetabular Labral Repair, Gluteus Medius Repair, Proximal Hamstring Repair

The AlphaVent Knotless SP Biocomposite Anchors (herein referred to as the subject device(s)) are bone anchors with a screw-in mechanism. The subject device is comprised of a poly-ether-ether-ketone (PEEK) eyelet and a biocomposite (Poly-L-lactic Acid (PLLA)/beta-tricalcium phosphate (β-TCP)) anchor body, pre-assembled onto a disposable stainless-steel inserter, which enables insertion of the anchor into bone either via a self-punching mechanism or after creation of a pilot hole. The devices are single use, provided sterile, and are packaged in sterile barrier systems (SBS).

Connected OR Hub with Device and Voice Control: The use of the Connected OR Hub with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the Connected OR Hub with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device. SDC4K Information Management System with Device and Voice Control: The use of the SDC4K Information Management System with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the SDC4K Information Management System with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control are network compatible hardware platforms that carry out Medical Device Data System (MDDS) functionalities and allows the user to control the state, selection, and settings of compatible connected devices both wired and wirelessly. The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control consists of the following components: - 1) Base Console which includes: - a) Medical Device Data System (MDDS) functionalities - b) Optional Device Control feature - c) Optional Voice Control feature - d) Optional Video Image Processing (VIP) feature - 2) Device Control Package (software activation USB dongle and a handheld Infrared (IR) remote control) - 3) Voice Control Package (software activation USB dongle and a wireless headset and base station) - 4) Video Image Processing package (software activation USB dongle) - 5) Connected OR Spoke (MDDS)

The Stryker ICONIX anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. Specific indications are listed below. Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair. Deltoid Repair, Capsular Shift or Capsulolabral Repair. Hand/Wrist: Scaphulolunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/ Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Repair. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis, Medial Patellofemoral Ligament (MPFL) Repair/Reconstruction, Quadriceps Tendon Repair. Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair, Proximal Hamstring Repair. The Stryker ICONIX Anchors are intended for single use only.

The ICONIX Anchors, ICONIX TT Anchors, and ICONIX Anchors with Needles are soft tissue fixation devices with a push-in design, provided preloaded on a disposable inserter. ICONIX Anchors with Needles have needles attached to the free ends of all working sutures. All of the ICONIX All-Suture Anchors are composed of a sheath structure that contains one or more working sutures. The sheath bunches as the anchor is deployed to fixate in bone. Once the anchor has been inserted in the bone, the working sutures are used to complete the soft tissue repair or reconstruction procedure, in accordance with the surgeon's preferred technique for procedures within the indications for use.

The 1688 4K Camera System with Advanced Imaging Modality is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ endoscope/ sinuscope/ sinuscope is indicated for use. The 1688 4K Camera System with Advanced Imaging Modality is indicated for use in adults and pediatric patients. A few examples of the more common endoscope surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair. Iaparoscopic appendectomy, laparoscopic pelvic lymph node detection, laparoscopically assisted hysterectomy. Iaparoscopic anterior spinal fusion, anterior cruciate ligament reconstruction, nnee arthroscopy, small joint arthroscopy, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.

The 1688 4K Camera System with Advanced Imaging Modality is an endoscopic camera system that produces live video in the surgical field during surgical endoscopic procedures. The system is sensitive in the visible and infrared spectrums. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible endoscopes, which are amera head. The 1688 4K Camera System consists of three main components: (1) a camera control unit (CCU); (2) a camera head with an integral cable that connects to the CCU; and (3) a coupler for attaching an endoscope to the camera head.

The SPY Cystoscopes/Hysteroscopes are intended to provide visualization in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site.

The SPY Cystoscope/Hysteroscope is part of Stryker's rigid endoscope product portfolio. The SPY Cystoscope/Hysteroscope is an optical instrument used to visualize or image a patient's anatomy during minimally invasive, endoscopic procedures for examination, diagnosis or therapy. The SPY Cystoscope/Hysteroscope transmits light in the visible spectrum to illuminate the anatomy, then forms and relays the image of the surgical site to a camera system for image processing and display.

The AlphaVent Knotless SP PEEK Anchor is intended to be used for soft-tissue to bone fixation in the shoulder, foot and ankle, knee, hand and wrist, elbow, and hip in skeletally mature pediatric and adult patients. It is indicated 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 Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair, Secondary or Adjunct Fixation for ACL/PCL Reconstruction or Repair, Meniscal Root Repair, MPFL Repair/Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair Hip: Capsular Repair, Acetabular Labral Repair, Gluteus Medius Repair, Proximal Hamstring Repair

The AlphaVent Knotless SP PEEK Anchors (herein referred to as the subject device(s)) are bone anchors with a screw-in mechanism. The subject device system is comprised of a poly-ether-etherketone (PEEK) eyelet and anchor body, pre-assembled onto a disposable stainless-steel inserter, which enables insertion of the anchor into bone via self-punching or after creation of a pilot hole. The devices are single use, provided sterile, and are packaged in sterile barrier systems (SBS). The AlphaVent Knotless SP PEEK Anchors are sterilized via Ethylene Oxide to a Sterility Assurance Level of 106. The devices are intended to be used in a professional healthcare facility.

The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ endoscope/ arthroscope/ sinuscope is indicated for use. The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in adults and pediatric patients. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy. Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection. Laparoscopically assisted hysterectomy. Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the 1788 4K Camera System with Advanced Imaging Modality are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT/neurosurgeons and urologists.

The 1788 4K Camera System with Advanced Imaging Modality is an endoscopic camera system that produces live video in the surgical field during surgical endoscopic procedures. The system is sensitive in the visible, infrared spectrums. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible to the camera head. The 1788 4K Camera System consists of three main components: (1) a camera control unit (CCU); (2) a camera head with an integral cable that connects to the CCU; and (3) a coupler for attaching an endoscope to the camera head.