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The OsteoFab® Suture Anchors are intended to be used for the fixation/reattachment of soft tissue to bone in the shoulder, knee, hand and wrist, elbow, and foot and ankle 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 Repair. Knee: Extra Capsular Ligament Repair, Patellar Realignment and Tendon Repairs, and Illiotibial Band Tenodesis. Hand and Wrist: Ulnar or Lateral Collateral Ligament Reconstruction, Collateral Ligament Reconstruction or Repair. Elbow: Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair, Biceps Tendon Repair. Foot and Ankle: Hallux Valgus Repairs, Medial or Lateral Instability Repairs and Reconstructions, Achilles Tendon Repairs and Reconstructions, Midfoot Reconstructions, Metatarsal Ligament/Tendon Repairs and Reconstructions, Bunionectomy.

The OsteoFab® Suture Anchor is a single procedure suture anchor device for the reattachment of soft tissue to bone in shoulder, knee, hand and wrist, elbow, and foot and ankle procedures. This reattachment of damaged soft tissue is achieved with suture that is threaded through an anchor which is fixated in bone via interference fit between the anchor and bone. The anchor is mounted on a custom inserter and threaded with recommended suture before deployment. The OsteoFab® Suture Anchors are manufactured from polyetherketone (PEKK) polymer in Oxford Performance Materials, Inc.'s proprietary additive manufacturing process. The OsteoFab® Suture Anchors are available in three sizes (4.5, 5.5, ad 6.5mm) and are provided non-sterile.

The OsteoFab Patient Specific Cranial Device (OPSCD) is intended for the replacement of bony voids in the cranial skeleton. OPSCDs may be used to fit pre-planned virtual defects in the instance of single stage cranioplasty procedures.

An OsteoFab® Patient Specific Cranial Device (OPSCD) is built individually for each patient to correct defects in cranial bone. OPSCDs are constructed with the use of the patient's CT scan and computer aided design is used to determine the geometry of each implant. OPSCDs are built by laser sintering polyetherketone (PEKK) polymer in Oxford Performance Materials' OsteoFab® process. OPSCDs are attached to native bone with commercially available cranioplasty fixation systems and are a non-load bearing, single use device. OPSCDs are provided non-sterile.

The OsteoFab® Patient Specific Facial Device (OPSFD) is designed individually for each patient for enhancement, to correct trauma, and/or to correct defects in facial bone. The OPSFD is also designed individually for non-load bearing enhancement of mandibular bone.

HTR-PEKK is a custom implant and the shapes and sizes vary within the following specifications: (1) maximum diameter is 20cm (2) minimum thickness is 1mm (2mm in areas of fixation), (3) maximum thickness is 20mm and the maximum thickness for holes is 10mm, (4) maximum open density is 25%, (5) minimum as designed through-hole diameter is 3mm, (6) maximum as designed though-hole size must meet these specifications (7) minimum distance from the edge of an as designed through-hole (for a cluster of perfusion-holes) to the edge of a device is 15mm, (8) minimum distance from the center of an as designed dimple to the edge for plating is 2.5mm for a 1.5mm diameter screw, (9) minimum distance from the center of an as designed dimple to the edge for lagging is 2.5mm for a 1.5mm diameter screw, (10) minimum distance between two lag holes is 3.25mm for a 1.5mm diameter screw, (11) minimum distance from the center of an as designed dimple to the edge for lagging is 3.75mm for a 2mm diameter screw, and (12) minimum distance between two lag holes is 3.75mm for a 2mm diameter screw. The OPSFD is constructed with the use of the patient's CT imaging data and computer aided design to determine the dimensions of each implant. The OPSFD is built by a LASER sintering machine. The OPSFD is attached to native bone with commercially available fixation systems. The OPSFD is a non-load bearing single use device and it is shipped non-sterile.

SpineFab® Vertebral Body Replacement (VBR) System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to turnor or trauma (i.e. fracture). The VBR device is intended for use with autograft and/or allograft bone graft material and must be used with supplemental fixation systems.

The SpineFab® VBR implant is a non-custom implant. The SpineFab® VBR Implants consist of 48 different variations and each one of six different configurations (Small Parallel, Medium Parallel, Large Parallel, Small Lordotic, Medium Lordotic, and Large Lordotic) with the only difference on each configuration being the height. This device is manufactured using polyetherketoneketone (PEKK) polymer using additive manufacturing and contains tantalum radiographic markers. The implants have an open shaft to allow for the placement of allograft or autograft. The implants have several other features: - Notches that are an aid to implant insertion, - Tantalum markers which allow for easy radiographic visualization, and - Teeth-like structures meant to engage the vertebral endplates for stabilization in vivo. SpineFab® Vertebral Body Replacement (VBR) System is shipped non-sterile and the sterilization recommendations documented in the instructions for use (IFU) are according to ANSI/AAMI ST79 "Comprehensive Guide to Steam Sterility Assurance in Health Care Facilities" have been validated.

The OsteoFab™ Patient Specific Facial Device (OPSFD) is designed individually for each patient for enhancement, to correct trauma, and/or to correct defects in facial bone. The OPSFD is also designed individually for non-load bearing enhancement of mandibular bone.

An OsteoFab® Patient Specific Facial Device (OPSFD) is built individually for each patient. The OPSFD is made of polyetherketone (PEKK) polymer and built by a LASER sintering machine. The OPSFD is constructed with the use of the patient's CT imaging data and computer aided design to determine the dimensions of each implant. OPSFDs come in a variety of configurations that depend on the geometry of the application. OPSFDs are oblong and (for an individual patient) have shapes and sizes that vary within the following specifications: (1) maximum diameter is 20 cm (2) minimum thickness is 1 mm, (3) maximum thickness is 10 mm, (4) maximum open density is 25%, (5) minimum as built hole diameter is 3 mm, (6) maximum as built hole diameter is 5 mm, and (6) minimum distance from the edge of an as built hole to the edge of a device is 15 mm. The OPSFD is attached to native bone with commercially available fixation systems and it is a permanent implant. The OPSFD is a non-load bearing single use device and it does not impart mechanical strength to the implant area. The OPSFD implant is shipped non-sterile and the sterilization recommendations documented in the instructions for use (IFU) are according to ANSI/AAMI ST79 "Comprehensive Guide to Steam Sterility Assurance in Health Care Facilities" have been validation for gravity displacement steam sterilization was conducted at 135°C (275°F) with a half cycle of five (5) minutes. The validation for prevacuum steam sterilization was conducted at 132°C (270°F) with a half cycle of two (2) minutes.

The OsteoFab™ Patient Specific Cranial Device (OPSCD) is intended for the replacement of bony voids in the cranial skeleton.

An OsteoFab™ Patient Specific Cranial Device (OPSCD) is built individually for each patient to correct defects in cranial bone. The OPSCD is constructed with the use of the patient's CT imaging data and computer aided design to determine the dimensions of each implant. The OPSCD is built by a LASER sintering machine. The OPSCD is attached to native bone with commercially available cranioplasty fixation systems. The OPSCD is a non-load bearing single use device and it is non-sterilization instructions documented in the package insert have been validated.