genex®

The only remaining evidence of the trauma

Simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects

genex is a catalyst for bone healing. It complements the body’s natural healing processes, enabling the optimal remodeling of bone architecture to that of native trabecular bone. In 12 months, genex is completely absorbed and remodeled while leaving no foreign artifacts after resorbtion.1,2

  • Cleared for bony voids and defects that are not intrinsic to stability of the bony structure.

Biphasic composite with purity and balance

genex is specifically formulated to provide the desired balance of scaffold strength and persistence in the body with optimum handling, workability and remodeling.

Our proprietary recrystallization and purification methods remove impurities such as:6
✘ No inflammatory pyrophosphates
✘ No slow and non-absorbing compounds such as hydroxyapatite

Completely absorbed to leave no trace

genex is a precisely balanced β-tricalcium phosphate/calcium sulfate hemihydrate compound with distinct design properties:

  • Contains no hydroxyapatite (HA)
  • Negatively charged surface chemistry
  • Compressive strength similar to trabecular bone3-5

genex provides a powerful osteoconductive scaffold for accelerated bone restoration and helps to hinder soft tissue ingrowth:

  • Enhances osteogenic response10
  • Completely absorbed within 12 months1
  • Several studies have concluded healthy bone is restored in a clinically relevant timeframe7-9

Completely absorbed within 12 months1,2

genex contains no hydroxyapatite. HA can only be absorbed at 1–2% per year12

Large animal model. Decalcified histology H & E stain

Implantation
8 weeks
16 weeks
36 weeks

Several studies have concluded healthy bone is restored in a clinically relevant timeframe7-9

genex restores bone to normal trabecular structure1

Tibial plateau fracture
Post-operative
15 months

Enhances the osteogenic response to accelerate bone growth – up to 5x normal levels10

In-vitro results are not necessarily indicative of clinical performance

Unrivaled flexibility for delivery and application

With one of the most comprehensive bone graft substitute systems at your fingertips, genex equips you with everything you need to adapt to the wide ranging and sometimes unpredictable demands of trauma surgery.

From difficult-to-reach sites or minimally invasive procedures, genex enables you to inject, mold or prepare beads according to your chosen technique.

The genex closed-mixing system maximizes efficiency and provides the assurances of:

  • fully supported aseptic technique
  • shorter preparation time and extended working time
  • reduced waste

genex has a working time of 3 to 5 minutes and is drillable after 15 minutes.

genex® products
genex Bone Graft Substitute

Setting paste for injecting, molding or preparing beads

  • Available in 3cc, 5cc and 10cc packs
  • Working time of 3 to 5 minutes
  • Drillable after 15 minutes
Introducing genex Bone Graft Substitute
01:27
How to prepare and deliver genex Bone Graft Substitute
05:36
Library

Listed below are 4 of the most relevant articles for this product but there is much more unrivalled evidence to explore on our Library page.

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Frequently asked questions
What is genex indicated for?

genex offers successful long-term outcomes across a range of surgical applications in the upper and lower extremities, including: tibial plateau fractures, core decompressions, long-bone non-unions, critical bone defects, humeral head fractures, acetabular voids and revisions.

genex is designed to promote regeneration of bone in osseous defects.  It is absorbed and replaced with bone during the healing process.

genex is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure.

genex is indicated to be gently packed into voids or defects of the skeletal system (i.e. long bones, extremities, posterolateral spine and pelvis).

genex resultant paste can be injected, digitally packed into the bone void to cure in situ or molded into solid implants that are to be gently packed into the defect. The bony defects or cavities may be surgically created or the result of traumatic injury.

What is genex contraindicated for?

Filling of defects which are intrinsic to the stability of the bony structure; severe vascular or neurological disease; uncontrolled diabetes; severe degenerative bone disease; pregnancy; uncooperative patient who can’t or won’t follow post-operative instructions including individuals who abuse drugs or alcohol; hypercalcaemia; use in the cranium; use in vertebral compression fractures.

How long does genex take to absorb in bone?

genex is completely absorbed within 12 months.

Is genex drillable?

Yes. 15 minutes after the addition of the mixing solution.

How long do I have to inject genex?

genex is injectable for up to 3 minutes from the addition of the mixing solution.

How long do I have to manually implant genex?

genex is moldable and implantable from minute 3 to 5 after the addition of the mixing solution.

Who is using genex?

genex is used in 15,000 cases every year, in over 30 countries –  including the USA, across a wide range of different indications.

References and regulatory statements

1. Yang HL et al. Bone healing response to a synthetic calcium sulfate/β-tricalcium phosphate graft material in a sheep vertebral body defect model. J Biomed Mater Res B Appl Biomater 2012;100B(7):1911–21. 2. Clinical case study: Mr A Nisar and Mr S Gopal; Proximal femur fracture, Data on file. 3. Biocomposites internal testing: Biomaterials Compressive strength; Applicable methodology ISO/DIS 18531:2015(E) Implant for surgery – Calcium phosphate bioceramics – Characterization of hardening bone paste materials. 2015, MA0390R1. 4. Misch CE, Qu Z, Bidez MW. Mechanical properties of trabecular bone in the human mandible: implications for dental implant treatment planning and surgical placement. J Oral Maxillofac Surg. 1999 Jun;57(6):700-6; discussion 706-8. doi: 10.1016/s0278-391(99)90437-8. PMID: 10368096. 5. Dunham CE, Takaki SE, Johnson JA, Dunning CE. Mechanical properties of cancellous bone of the distal humerus. Clin Biomech (Bristol, Avon). 2005 Oct;20(8):834-8. doi: 10.1016/j.clinbiomech.2005.05.014. PMID: 16023773. 6. Biocomposites internal and external testing: genex Bone Graft Substitute technical file: Section 3.1.7 (Rev1) Final product specification, 2022. 7. Clinical case study: Mr HK Sharma; Tibial plateau fracture: Data on file. 8. Clinical case study: Prof JB Richardson; Distal tibia non-union: Data on file. 9. Clinical case study: Mr P Thompson; Single stage revision ACL reconstruction: Data on file. 10. Cooper JJ et al. Enhancing the osteogenic potential of bioabsorbable implants through control of surface charge. Presented at the Society for Biomaterials 2007 Annual Meeting, April, 2007: Chicago, Illinois, USA. 11. J J Cooper, J A Hunt., The Significance of Zeta Potential in Osteogenesis. Poster presented at Society for Biomaterials 2006 Annual Meeting, Pennsylvania, USA. 12. Pina S, Ferreira JMF. Bioresorbable plates and screws for clinical applications: A review. J Healthcare Engineering 2012;3(2):243–60.

For indications, contraindications, warnings and precautions see Instructions for Use.

©2022, Biocomposites, genex, Power to Restore and DRy26 are trademarks/registered trademarks of Biocomposites Ltd. All rights reserved. No unauthorized copying, reproduction, distributing or re-publication is allowed unless prior written permission is granted by the owner, Biocomposites Ltd.

Patents granted: EP 1390086 B1, US 8632796, CN ZL02809194.9, US 8496955

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