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MagnetOs MIS is intended to fill bony voids or gaps of the skeletal system, i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine. The osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the extremities, pelvis, intervertebral disc space and posterolateral spine, MagnetOs MIS may be used standalone or with autograft as a bone extender. When used in intervertebral body fusion procedures, MagnetOs MIS must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. MagnetOs MIS resorbs and is replaced with bone during the healing process.

MagnetOs MIS includes a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects. MagnetOs MIS graft material is a mixture of ceramic granules premixed with a synthetic polymeric binder that provides cohesion between the granules. The ceramic portion of MagnetOs MIS consists of 65–75% tri-calcium phosphate (TCP – Ca3(PO4)2) and 25–35% hydroxyapatite (HA – Ca10(PO4)6(OH)2) granules. While the polymeric binder is rapidly resorbed after implantation, the granules of MagnetOs MIS guide the three-dimensional regeneration of bone in the defect site into which it is implanted. New bone will be deposited on the surface of the graft when placed next to viable host bone. The graft resorbs and is replaced by bone during the natural process of bone remodeling. MagnetOs MIS graft material is provided in a 5cc pre-filled cartridge, packed together with a delivery system kit in a ready-to-use format. The MagnetOs MIS delivery system allows users to apply the bone graft into the defect. MagnetOs MIS is gamma-sterilized and sterile packaged for single use only.

MagnetOs Putty is an implant intended to fill bony voids or gaps of the skeletal system, i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. MagnetOs Putty may be used standalone or mixed with autograft. When used in intervertebral body fusion procedures, MagnetOs Putty must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. MagnetOs Putty resorbs and is replaced with bone during the healing process.

MagnetOs Putty is a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects. MagnetOs Putty consists of 65-75% Tri-Calcium Phosphate (TCP - Cas(PO4)2) and 25-35% Hydroxyapatite (HA - Ca10(PO4)6 (OH)2) granules with a porous trabecular structure that resembles the interconnected porosity of human cancellous bone. The surface of the granules in MagnetOs Putty is covered with needle-shaped features that are submicron in size. The granules are premixed with a synthetic polymeric binder. The biocompatible polymeric binder is composed of Poly L (Lactic Acid) (PLA) and Poly(Ethylene Glycol) (PEG) in a triblock polymer PLA-PEG-PLA; which consists of 10-20% PLA and 80-90% PEG. The fast-resorbing polymeric binder in the subject device is designed to improve handling properties, as well as reduce the risk of granules migration. While the polymeric binder is rapidly resorbed after implantation, the granules guide the three-dimensional regeneration of bone in the defect site into which it is implanted. When placed next to viable host bone, new bone will be deposited on the surface of the implant. The implant resorbs and is replaced by bone during the natural process of bone remodeling. MagnetOs Putty is a ready-for-use product. Pressure applied by manipulation allows the shaping of the devices to conform to the contours of bony defects. MagnetOs Putty is gamma-sterilized, comes in several sizes in block form and is sterile packaged for single use only. MagnetOs Putty is MRI (Magnetic Resonance Imaging) Safe.

MagnetOs Granules is an implant intended to fill bony voids or gaps of the skeletal system, i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. When used in posterolateral spine, extremities and pelvis, MagnetOs Granules may be used standalone or mixed with autograft, blood, and/or bone marrow. When used in intervertebral body fusion procedures, MagnetOs Granules must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler and hydrated with blood. MagnetOs Granules may also be mixed with autograft. MagnetOs Granules resorbs and is replaced with bone during the healing process.

MagnetOs Granules is a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects. MagnetOs Granules consists of 65-75% tri-calcium phosphate (TCP - Ca3(PO4)2) and 25-35% hydroxyapatite (HA - Ca10(PO4)6(OH)2) granules with a porous trabecular structure that resembles the interconnected porosity of human cancellous bone. MagnetOs Granules guide the three-dimensional regeneration of bone in the defect site into which it is implanted. New bone will be deposited on the surface of the graft when placed next to viable host bone. The graft resorbs and is replaced by bone during the natural process of bone remodeling. MagnetOs Granules is a ready-to-use product. MagnetOs Granules is provided in vials in a range of product volumes. MagnetOs Granules is gamma-sterilized and sterile packaged for single use only. The total interconnecting porosity of MagnetOs Granules is 70 ± 15%. Pore diameters in the scaffold range from 0 to 1000 µm (1mm).

MagnetOs Putty is an implant intended to fill bony voids or gaps of the skeletal system i.e., the extremities, pelvis and posterolateral spine. MagnetOs Putty may be used standalone or mixed with autograft. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. MagnetOs Putty resorbs and is replaced with bone during the healing process.

MagnetOs Putty is a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects. MagnetOs Putty consists of 65-75% Tri-Calcium Phosphate (TCP - Ca3(PO4)2) and 25-35% Hydroxyapatite (HA - Ca10(PO4)6 (OH)2) granules with a porous trabecular structure that resembles the interconnected porosity of human cancellous bone. The granules are covered with submicron-sized features and are premixed with a synthetic polymeric binder. The biocompatible polymeric binder is composed of Poly L (Lactic Acid) (PLA) and Poly(Ethylene Glycol) (PEG) in a triblock polymer PLA-PEG-PLA; which consists of 10-20% PLA and 80-90% PEG. The fast-resorbing polymeric binder in the subject device is improve handling properties, as well as reduce the risk of granules migration. While the polymeric binder is rapidly resorbed after implantation, the granules in both devices guide the three-dimensional regeneration of bone in the defect site into which it is implanted. When placed next to viable host bone, new bone will be deposited on the surface of the implant. The implant resorbs and is replaced by bone during the natural process of bone remodeling. MagnetOs Putty is a ready-for-use product. Pressure applied by manipulation allows the shaping of the devices to conform to the contours of bony defects. MagnetOs Putty is gamma-sterilized, comes in several sizes in block form and is sterile packaged for single use only. This 510(k) expands the device's indications for use in K181958 as an autograft extender only to also allow use of the device alone in posterolateral spine.

MagnetOs Easypack Putty is intended to filly bony voids or gaps of the skeletal system. i.e., the intervertebral disc space, and posterolateral spine. The osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the intervertebral disc space and posterolateral spine, MagnetOs Easypack Putty must be used with autograft as a bone extender. When used in intervertebral body fusion procedures, MagnetOs Easypack Putty must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. MagnetOs Easypack Putty resorbs and is replaced with bone during the healing process.

MagnetOs Easypack Putty is a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects, MagnetOs Easypack Putty consists of 65-75% tri-calcium phosphate (TCP - Ca3(PO4)2) and 25-35% hydroxyapatite (HA - Ca10(PO4)6(OH)2) granules, premixed with a synthetic polymeric binder that provides cohesion between the granules. New bone will be deposited on the surface of the graft when placed next to viable host bone. The graft resorbs and is replaced by bone during the natural process of bone remodeling. MagnetOs Easypack Putty is a ready-to-use product. Pressure applied by manipulation allows users to shape MagnetOs Easypack Putty to conform to the contours of bony defects. MagnetOs Easypack Putty is provided in open-ended syringes in a range of product volumes. MagnetOs Easypack Putty is gamma-sterilized and sterile packaged for single use only.

MagnetOs Flex Matrix is intended to fill bony voids or gaps of the skeletal system, i.e., the intervertebral disc space, and posterolateral spine. The osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the intervertebral disc space and posterolateral spine, MagnetOs Flex Matrix must be hydrated with bone marrow aspirate (BMA) and used as an extender to autograft bone. When used in intervertebral body fusion procedures, MagnetOs Flex Matrix must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. MagnetOs Flex Matrix resorbs and is replaced with bone during the healing process.

MagnetOs Flex Matrix is a resorbable, osteoconductive bone void filler for the repair of bony defects. The product is biocompatible. MagnetOs Flex Matrix is a mixture of medical grade collagen and hydroxyapatite and Btricalcium phosphate ceramic (92.5-95.5 wt% MagnetOs Granules and 4.5-7.5 wt% collagen). The ceramic portion of MagnetOs Flex Matrix consists of 75-65% B-Tri-Calcium Phosphate and 25-35% Hydroxyapatite. The collagen is produced of highly purified bioresorbable bovine split skin and consists mainly of collagen type I. The components are mixed in a slurry and lyophilized, which results in a highly porous sponge matrix that provides cohesion between the MagnetOs Granules without inhibiting the granule surface structure. MagnetOs Flex Matrix is a ready-to-use product. Upon hydration, the material is moldable and allows users to shape MagnetOs Flex Matrix to conform to the contours of bony defects. MagnetOs Flex Matrix is supplied as a ready-to-use strip, it is sterile packaged and gammasterilized for single patient use only.

MagnetOs Easypack Putty is intended to fill bony voids or gaps of the skeletal system, i.e. posterolateral spine. In the posterolateral spine, MagnetOs Easypack Putty must be used with autograft as a bone graft extender. The osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the bony structure. MagnetOs Easypack Putty resorbs and is replaced with bone during the healing process.

MagnetOs Easypack Putty is a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects. MagnetOs Easypack Putty consists of 65–75% tri-calcium phosphate (TCP – Ca3(PO4)2) and 25-35% hydroxyapatite (HA - Ca10(PO4)6(OH)2) granules, premixed with a synthetic polymeric binder that provides cohesion between the granules. New bone will be deposited on the surface of the graft when placed next to viable host bone. The graft resorbs and is replaced by bone during the natural process of bone remodeling. MagnetOs Easypack Putty is a ready-to-use product. Pressure applied by manipulation allows users to shape MagnetOs Easypack Putty to conform to the contours of bony defects. MagnetOs Easypack Putty is provided in open-ended syringes in a range of product volumes. MagnetOs Easypack Putty is gamma-sterilized and sterile packaged for single use only.

MagnetOs Putty is an implant intended to fill bony voids or gaps of the skeletal system i.e., the extremities, pelvis and posterolateral spine. In the posterolateral spine, MagnetOs Putty must be used with autograft as bone graft extender. In extremities and pelvis, MagnetOs Putty is used alone. These osseous defects may be surgically created of of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. MagnetOs Putty resorbs and is replaced with bone during the healing process.

MagnetOs Putty is a synthetic, resorbable and osteoconductive bone void filler for the repair of bony defects, containing 65-75% beta-Tri-Calcium Phosphate (TCP, Ca3(PO4)2) and 25-35% Hydroxyapatite (HA, Ca5(PO4)3OH) granules, premixed with a synthetic polymeric binder that provides cohesion between the granules. MagnetOs Putty is gamma-sterilized, comes in several sizes in block form and is sterile packaged for single use only.

MagnetOs Putty is an implant intended to fill bony voids or gaps of the skeletal system, i.e., posterolateral spine. MagnetOs Putty must be used with autograft as a bone graft extender in the posterolateral spine. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. MagnetOs Putty resorbs and is replaced with bone during the healing process.

MagnetOs Putty is a synthetic, resorbable and osteoconductive bone void filler for the repair of bony defects, containing 65-75% Tri-Calcium Phosphate (TCP, Cas(PQ2)>) and 25-35% Hydroxyapatite (HA. Cag(PO2)3OH) granules, premixed with a synthetic polymeric binder that provides cohesion between the granules. MagnetOs Putty is gamma-sterilized, comes in four sizes in block form and is sterile packaged for single use only.