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The Allograft Delivery Device is intended to be used for the delivery of hydrated allograft to an orthopedic surgical site.

The Allograft Delivery Device is a sterile, single-use, disposable allograft delivery device intended for the delivery of hydrated allograft bone graft material to an orthopedic surgical site. The delivery device consists of a cannula used for containing and delivering the allograft material to the surgical site and a push rod required for expressing the allograft material from the cannula. The cannula component is an open bore tube with a male double-threaded lock interface that mates with a pre-existing allograft syringe. The cannula component may be used to dispense allograft to a patient orthopedic surgical site. When used as an ancillary device to orthopedic surgical procedures that require the placement of allograft Delivery Device can deliver a prepared amount of allograft material.

SIGNAFUSE Bioactive Strip (SBS) is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. SIGNAFUSE Bioactive Strip (SBS) is indicated to be combined with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis, posterolateral spine, and intervertebral disc space. When used in the posterolateral spine, SIGNAFUSE Bioactive Strip (SBS) is to be used as an autograft extender. When used in intervertebral disc space. SIGNAFUSE Bioactive Strip (SBS) is to be used as an autograft extender with an intervertebral body fusion device cleared by FDA for use with a bone void filler. The device resorbs and is replaced by host bone during the healing process. SIGNAFUSE Putty is a bone void filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. SIGNAFUSE Putty is indicated to be packed gently into bony voids or gaps of the skeletal system (i.e., extremities, pelvis, posterolateral spine, and intervertebral disc space fusion procedures). SIGNAFUSE Putty can also be used with autograft as a bone graft extender in the posterolateral spine. When used in intervertebral body fusion procedures, SIGNAFUSE Putty can used on its own or as a bone graff extender, and with an intervertebral body fusion device cleared by FDA for use with a bone void filler. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.

SIGNAFUSE Bioactive Strip (SBS) is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix, and it identical to the device cleared in K193513. SIGNAFUSE Putty is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in an alkylene oxide polymer (AOP) resorbable carrier and is identical to the device cleared in K132071. The SIGNAFUSE Family of devices are single use implants in contact with bone that are sterilized by irradiation with a sterility assurance level (SAL) of 106. This submission expands the SIGNAFUSE Family indication to include use in the intervertebral space.

The Misonix Inc. neXus® Ultrasonic System is intended for the fragmentation, emulsification and aspiration of both soft and hard (i.e., bone) tissue. The indications for use for the Standard Handpiece in combination with BoneScalpel® and SonicOne® OR probe kit accessory configurations, the SonaStar® Long and Short handpieces in combination with SonaStar® probe kit accessory configurations, the BoneScalpel Access® handpiece with BoneScalpel Access® probe kit accessory configurations, and the SonaStar Elite Handpiece with probe kit accessory configurations are listed below. Standard Handpiece with BoneScalpel Probe Kit Indicated for use in the fragmentation, emulsification of soft and hard (e.g., bone) tissue in the following surgical specialties: - · Neurosurgery - · Gastrointestinal and Affiliated Organ Surgery - · Urological Surgery - · Plastic and Reconstructive Surgery - · General Surgery - · Orthopedic Surgery - · Gynecology External genitalia - condyloma - benign tumors (lipomas, fibromas, and leiomyomas) - malignant primary and metastatic tumors of all types and the following cystic lesions: Bartholin's cysts, Vestibular adenitis, Inclusion cysts, Sebaceous cysts Abdominal area - any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus except as contraindicated for uterine fibroids. - · Thoracic Surgery Limited pulmonary resection such as segmentectomical subsegmentectomies and metastatectomies. · Wound Care The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement. Standard Handpiece with SonicOne Probe Kits Indicated for use in the fragmentation and aspiration of soft and hard tissue (i.e. bone) in the following surgical specialty: · Wound Care The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement. · Plastic and Reconstructive Surgery neXus SonaStar Handpieces with SonaStar Probe Kits Indicated for use in the fragmentation and aspiration of both soft and hard (i.e., bone) tissue in the following surgical specialties: · Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy · Urological Surgery - including removal of renal parenchyma during nephrectomy or partial nephrectomy - · Plastic and Reconstructive Surgery · General Surgery - including removal of benign or malignant tumors or other unwanted tissue in open or minimally invasive general surgical procedures - · Orthopedic Surgery - · Gynecological Surgery except as contraindicated for uterine fibroids. - · Thoracic Surgery · Laparoscopic Surgery – including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy · Thoracoscopic Surgery The SonaStar Handpieces may also be combined with electrosurgery using optional RF surgery interface components. Bone Scalpel Access Handpiece with BoneScalpel Access Probe Kits Indicated for use in the fragmentation of soft and hard (e.g., bone) tissue in the following surgical specialties: - · Neurosurgery - · Gastrointestinal and Affiliated Organ Surgery - · Urological Surgery - · Plastic and Reconstructive Surgery - · General Surgery - Orthopedic Surgery - · Gynecology External genitalia - condyloma - benign tumors (lipomas, and leiomyomas) - malignant primary and metastatic tumors of all types and the following cystic lesions: Bartholin's cysts, Vestibular adentis, Inclusion cysts, Sebaceous cysts Abdominal area - any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus except as contraindicated for uterine fibroids. · Thoracic Surgery Limited pulmonary resection such as segmentectomical subsegmentectomies and metastatectomies. SonaStar Elite Handpiece with SonaStar Elite Probe Kits Indicated for use in the fragmentation of soft and hard (e.g., bone) tissue in the following surgical specialties: - · Neurosurgery · Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy - · Urological Surgery including removal of renal parenchyma during nephrectomy or partial nephrectomy - · Plastic and Reconstructive Surgery · General Surgery - including removal of benign or malignant tumors or other unwanted tissue in open or minimally invasive general surgical procedures - Orthopedic Surgery - · Gynecological Surgery except as contraindicated for uterine fibroids. - · Thoracic Surgery · Laparoscopic Surgery – including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy · Thoracoscopic Surgery The system may also be combined with electrosurgery using optional RF surgery interface components.

The neXus Ultrasonic Surgical Aspirator System is intended for fragmentation, emulsification and aspiration of both soft and hard (i.e.bone) tissue. The system includes a generator housed inside the console. A reusable handpiece is plugged directly into the front panel of the console. The generator and handpiece are compatible with various single use disposable "probes" which are selected and attached to the handpiece by the end user. An irrigation system provides sterile irrigant to the operative site. An aspiration system removes the fragmented, emulsified material and waste liquids from the operative site. Accessories include a wireless footswitch, various probe tip combinations, sterilization trays, probe covers, assembly & disassembly wrenches, irrigation tubing sets, disposable electrocautery cable, and waste collection canisters.

SIGNAFUSE Bioactive Bone Graft is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. SIGNAFUSE Bioactive Bone Graft is indicated to be combined with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, SIGNAFUSE Bioactive Bone Graft is to be used as an autograft extender. The device resorbs and is replaced by host bone during the healing process.

SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 4555 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.

MCS Bone Graft is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. MCS Bone Graft is indicated to be hydrated with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, MCS Bone Graft is to be used as an autograft extender. Following implantation, the graft resorbs and is replaced by host bone during the healing process.

MCS Bone Graft is a bone graft substitute comprising biphasic mineral granules suspended in a porous, bovine type I collagen matrix. The biphasic granules are 60% hydroxyapatite (HA) and 40% beta tri-calcium phosphate (betaTCP). The device is provided in a strip form and is supplied terminally sterile for single patent use. The device is designed to be combined with autologous bone marrow aspirate prior to facilitate packing into bony defects and is used with autologous bone in the posterolateral spine. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.