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Catalyst Bone Void Filler is indicated for filling bone voids or defects of the skeletal system (i.e., the posterolateral spine, intervertebral disc space, extremities, and pelvis) that are not intrinsic to the stability of the bony structure. These osseous defects may be surqically created or as a result of traumatic injury to the bone. Catalyst Bone Void Filler is a bone graft putty that is resorbed and replaced with bone during the healing process. Catalyst Bone Void Filler must be used with morselized autograft bone at a ratio of 1:1 by volume in the posterolateral spine. When used in intervertebral body fusion procedures, Catalyst Bone Void Filler must be used with morselized autograft bone at a ratio of 1:1 by volume with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic calcium phosphate bone void filler. OssDsign Catalyst contains 5.8 wt% silicon-substituted calcium phosphate granules suspended in a resorbable polymer gel. The final, finished OssDsign Catalyst is 30 wt% granules and 70 wt% polymer gel. The high surface area porous granules have been designed to deliver consistent and rapid bone ingrowth, remodeling, and cellmediated resorption during the bone healing process. The aqueous polymer gel phase binds the highly porous granules into a moldable, pliable formulation which enables OssDsign Catalyst to be implanted directly from the packaging without any further gelation, mixing or graft setting time. OssDsign Catalyst is provided sterile to the end user in 1 cc, 2.5 cc, 5 cc, and 10 cc syringe volumes. OssDsign Catalyst is identical to the currently marketed product Osteo3 ZP Putty (K193075). The cleared Osteo3 ZP Putty was launched in the USA in October 2021 and marketed under the name OssDsign Catalyst.

OSSDSIGN Cranial PSI is an implant intended for the reconstruction of cranial defects. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The ceramic component of Cranial PSI resorbs and is replaced with bone during the healing process. Cranial PSI is indicated for use in patients in whom cranial growth is complete and for use with an intact dura, with or without duraplasty.

OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient's unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic component of Cranial PSI resorbs and is replaced with bone during the healing process. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids.

Cranial PSI Accessories are indicated for use as accessories to the OSSDSIGN Cranial PSI for the reconstruction of cranial defects. They are indicated for non-load bearing applications for patients in whom cranial growth is complete and for use with an intact dura, with or without duraplasty.

OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device. They are additively manufactured from PA2200 polyamide material. Each Cranial PSI Accessory is patient-specific and corresponds to a patient's unique anatomical requirements. Cranial PSI Accessories are intended to support implantation of the corresponding Cranial PSI parent device; both devices are designed from the same patient-specific computed tomography image data set. Anatomical Model Original supports OSSDSIGN Cranial PSI by facilitating visual and tactile orientation for the physician of the patient's anatomy. It is provided non-sterile, is not intended to be sterilized and is not to be brought into contact with Cranial PSI, Plastic Drawing Guide or the Cranial Implant Trial. Anatomical Model Modified supports OSSDSIGN Cranial PSI by facilitating visual ● and tactile orientation for the physician after removal of physician-specified regions. It is provided non-sterile, is not intended to be sterilized and is not to be brought into contact with Cranial PSI, Plastic Drawing Guide or the Cranial Implant Trial. Plastic Drawing Guide supports accurate placement and fitting of OSSDSIGN Cranial PSI by assisting physicians in marking of bone intended for removal. Provided sterile. Cranial Implant Trial supports placement and fitting of OSSDSIGN Cranial PSI by . assisting physicians in confirming OSSDSIGN Cranial PSI fit, fixation point positions and soft tissue coverage. Provided sterile.

OSSDSIGN Cranioplug is an implant intended to cover and plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery. These osseous defects are surgically created and are not intrinsic to the stability of the bony structure. The ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is indicated for use in adults and adolescents age 12 and older.

OSSDSIGN Craniopluq003 is an osteoconductive calcium phosphate ceramic plug reinforced with a titanium mesh plate which together provide the mechanical performance, safety and efficacy properties. The fully cured calcium phosphate ceramic fills the void in the burr hole. The osteoconductive ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is sized to match standard 11mm and 14mm burr hole perforators.

OSSDSIGN Cranial PSI is intended for the reconstruction of cranial defects. It is indicated for non-load bearing applications for patients in whom cranial growth is complete and for use with or with or with or without duraplasty.

OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient's unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids.

OssDsign Cranioplug is intended to cover and plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery. It is cleared for use for non-weight bearing applications in adults and adolescents age 12 and older.

Cranioplug consists of a titanium (Ti) mesh plate with a biocompatible ceramic. Cranioplug implants are sized to mate with standard 14 mm burr holes common in surgical procedures. Each implant includes the completely formed Ti and fully cured CaP components in one device.