Search DePuy Synthes

search

Products

 

About this product

Division: Biomaterials
Category: Trauma

Norian Drillable is a biocompatible, 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 contains reinforcing fibers that enhance the material's structural integrity by providing added material toughness,* improving handling, allowing for drillability and increasing the material's resistance to cracking. Due to its unique material composition, when set, Norian Drillable closely resembles the mineral phase of bone and is gradually resorbed and replaced with bone during the natural healing process.

* Toughness is defined as a measure of a material's resistance to fracture when stressed. Data on file with DePuy Synthes.

Norian Drillable Syringes Norian Drillable microscopic view Norian Drillable filler representation with bone model Norian Drillable solution and product application Norian Drillable representation with bone model
 

Indications for Use

Indications

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)

Features & Benefits

  • Drillable: Cleared to be drilled, tapped and have screws placed through it at any time during or after the setting process
  • Reinforcing Fibers: Enhance structural integrity by providing added material toughness,* improving handling, allowing for drillability and increasing the material’s resistance to cracking
  • 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 bone1
  • Hardens in a warm, wet environment: Reducing the need to control moisture at the operative site
  • Isothermic hardening: Eliminates thermal injury to surrounding soft tissue
  • Closely resembles the mineral phase of bone: Gradually resorbed and replaced with bone during the natural healing process
  • Osteoconductive: Provides scaffold to support bony in-growth



* Toughness is defined as a measure of a material's resistance to fracture when stressed. Data on file with DePuy Synthes.

1 Cowin, S.C., ed. Bone Mechanics Handbook. 2nd ed. New York, NY: CRC Press, 2001. 16-3. Print.

J30812A

All medical devices have associated risks. Please refer to the package insert and other labeling for a complete list of indications, contraindications, precautions and warnings. For further information on DePuy Synthes Products, please contact your local DePuy Synthes Representative.
Back To Top