OsteoFab® Implants

OsteoFab® implants are produced using our proprietary 3D printing process. Our implants can be designed directly from a patient’s imaging (MRI or CT scan) for custom solutions, or using traditional design methods for series production of 3D printed standard implants. 

The complex designs made possible by our OsteoFab®technology help reduce intricate assemblies, eliminate manufacturing tooling, and prevent the need for coating or other post processing surface modification. 

Utilizing the most advanced biocompatible materials and manufacturing technology, our OsteoFab® process can reproduce exactly what you design, or exactly what nature intended, by "printing" medical implants for a perfect anatomical fit. However, this technology allows us to go beyond merely replicating shapes: we also have the ability to meet specific performance requirements as anatomically applicable.

 

 

 

 

 

Biomedical Devices 

OsteoFab® Suture Anchor 

The OsteoFab Suture Anchor system is comprised of 4.5, 5.5, and 6.5mm diameter anchors that are indicated for the reattachment of soft tissue to bone in the shoulder, knee, hand and wrist, elbow, and foot and ankle.  All suture anchors are manufactured from 3D printed polyetherketoneketone (PEKK) polymer via OPM’s OsteoFab process.  The suture anchors are sold with a simple, proprietary inserter and multiple sized awls that function across the three device sizes.  Product instrumentation is easily cleanable and reusable, which yields significant cost savings when compared to current disposable devices that are on the market.  The OsteoFab Suture Anchor line represents the first and only FDA cleared, 3D printed suture anchor device and OPM’s sixth successful OsteoFab regulatory clearance.

 

 

  • Bone-like Modulus 
  • Antibacterial Surface 
  • Participates in Fusion 
  • Micro-textured surface

 

 

 

OsteoFab® Patient Specific Facial Device (OPSFD)

The OsteoFab® Patient Specific Facial Device (OPSFD) is individually designed 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. 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 device is then manufactured via the OsteoFab® 3D printing laser sintering process. The OPSFD is attached to native bone with commercially available fixation systems and it is a single use, permanent implant that is non-load bearing and does not impart mechanical strength to the implant area. The OPSFD is sterilized at the healthcare facility using validated steam sterilization cycles.

Distributed by Zimmer Biomet

  • Patient specific
  • Perfect fit
  • Micro-textured surface
  • Complex geometries 

 

OsteoFab® Patient Specific Cranial Device (OPSCD)

The OsteoFab® Patient Specific Cranial Device (OPSCD) is intended for the replacement of bony voids in the cranial skeleton. 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 device is then manufactured via the OsteoFab® 3D printing laser sintering process. The OPSCD is attached to native bone with commercially available cranioplasty fixation systems and is a non-load bearing, single use device that is sterilized at the healthcare facility using validated steam sterilization cycles.

Distributed by Zimmer Biomet

  • Patient specific
  • Perfect fit
  • Micro-textured surface
  • Small to large defects up to 200mm in diameter, in one single implant 

 

OsteoFab® patient Specific Cranial Devices (OPSCD) Single Stage Surgery

OPSCDs are patient-specific cranial implants that are manufactured from 3D printed polyetherketoneketone (PEKK) polymer through OPM’s OsteoFab® process.  While originally cleared by the FDA in 2013 for two-stage cranioplasty procedures, this expanded indication allows OPSCDs to be used to fit pre-planned, virtual defects in the instance of single stage cranioplasty procedures.  With OPM’s expanded single stage indication, a virtual defect can now be created and a patient-specific cranial implant can be designed to fit the planned defect that will be created during the operation.  Ultimately, the single stage approach for cranioplasties results in less operating room time for the patient and surgeon, lower costs, and a better level of care.

 

 

SpineFab® VBR System

The 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 tumor 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. SpineFab® VBR implants are non-custom implants manufactured via the OsteoFab® 3D printing laser melting process and come in a broad range of sizes: three footprint sizes, each with multiple height options ranging from 15 to 50mm that come in either parallel (0°) or lordotic (7°) configurations. The SpineFab® VBR is a single use, load bearing device that is sterilized at the healthcare facility using validated steam sterilization cycles.

  • An open shaft to allow for the placement of allograft or autograft
  • Notches to aid implant insertion
  • Tantalum markers to allow for easy radiographic visualization
  • Micro-textured surface
  • Teeth like structures to engage the vertebral endplates for stabilization in-vivo