Norian® Drillable

Norian® Drillable is a biocompatible1, fiber reinforced calcium phosphate bone void filler that is intended to be placed into bony voids or defects of the extremities and pelvis either before or after final fixation.

Norian Drillable

Features & Benefits

    • Drillable: Cleared to be drilled, tapped and have screws placed through it at any time during or after the setting process2
    • Reinforcing Fibers: Enhance structural integrity by improving handling, allowing for drillability and increasing the material’s resistance to cracking3
    • Flexibility of application: Material can be implanted either before or after final fixation
    • Compressive strength: Reaches a maximum compressive strength of (35MPa Inject, 25MPa FSP) within 24 hours, which is greater than that of cancellous bone4
    • Isothermic hardening: Eliminates thermal injury to surrounding soft tissue5, 6
    • Closely resembles the mineral phase of bone: Gradually resorbed and replaced with bone during the natural healing process7, 8
    • Osteoconductive: Provides scaffold to support bony in-growth4, 9

Supporting Documentation

Resources

Norian Drillable Inventory Control Form

References

1Coll Ferrer, et al. F-S738 Norian Drillable / Norian Reinforced / CRANIOS REINFORCED. 6/27/18. Number: 500095369
2Jacobson. Norian Reinforced Mechanical Properties of Norian Reinforced Fast Set Putty. 3/31/05. FRN Test 59
3P. Leamy. Handling Properties of Fiber Reinforced Fast Set Putty Compared to Fast Set Putty. 2005. Reinforced Norian Test 85 Report.
4 Cowin, S.C., ed. Bone Mechanics Handbook. 2nd ed. New York, NY: CRC Press, 2001. 16-3. Print.
5Xinyin Liu. Setting Reaction Temperature and pH Determination for Rotary Mixer. 2005. FRN Test 62 Report.
6 Xinyin Liu. Setting Reaction Temperature and pH Determination for Fast Set Putty. 2005. FRN Test 56 Report.
7Evan Jacobson. Crystalline and Non-Crystalline Identification of Norian Reinforced Fast Set Putty. 2005. FRN Test 57 Report.
8 Evan Jacobson. Crystalline and Non-Crystalline Identification of Norian Reinforced for Rotary Mixer. 2005. FRN Test 63 Report.
9 Kim, J. et al. Fiber-reinforced calcium phosphate cement formulations for cranioplasty applications: A 52-week duration preclinical rabbit calvaria study. Willey Periodicals, INC. @2011.

Norian is a registered trademark of DSM Biomedical or its associates.
Bench testing is not indicative of clinical performance.

Indication Statement

Norian Drillable is intended for bony voids or defects of the extremities and pelvis 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. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. Norian Drillable can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure. Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. Norian Drillable is intended to be placed into bony voids either before or after final fixation.

Contraindications

The safety and effectiveness of this device for use in the spine has not been established.

Use of this device is contraindicated in the spine, including use in the pedicle, as this could be associated with leakage of the device material into the bloodstream, which could cause serious adverse events, including death.

Norian Drillable is not intended for use in the spine and should not be used in the presence of active or suspected infection.

Norian Drillable is not for screw augmentation.

Norian Drillable is not for use in:

  • Patients with traumatic open injuries that are predisposed to infection
  • Stress bearing applications
  • Areas where adjacent bone is avascular, or is incapable of supporting or anchoring the implanted rigid fixation hardware
  • Patients with compromised health (e.g. abnormal calcium metabolism, metabolic bone disease, a recent local untreated infection, vascular or severe neurological disease, infection, immunologic deficiencies or systemic disorders) that result in poor wound healing or will result in tissue deterioration over the implant site
  • Patients who are skeletally immature
  • Vertebral compression fractures
  • Intra‐articular space (i.e. material injected into the joint space)

114768-190521 DSUS