Global

‡ In these countries please contact our distributor

BIOSURE REGENESORB

Interference Screw

Overview

The BIOSURE REGENESORB Interference Screw it the first interference screw made out of an advanced biocomposite material, with an open-architecture design to allow for bone in-growth.

BIOSURE REGENSORB COPY pic 1

Micro-CT images showing new bone growth through the center cannulation of the BIOSURE REGENESORB Interference Screw at 12 weeks in an ACLR ovine model.1, 10


The unique BIOSURE REGENSORB Screw is the first interference screw made out of an advanced biocomposite material with an open-architecture design to allow for bone in-growth, while also providing the kind of performance expected with a solid absorbable interference screw.2

Graft Integration 1

Reliable Performance 2

Advanced Material 3

Open architecture to allow for bone to grow through the screw and attach to the graft

Strength comparable to a solid absorbable interference screw

REGENESORB Material is replaced by bone within 24 months in preclinical studies.


Allows Bone In-Growth
The open-architecture design of the BIOSURE REGENESORB Interference Screw eliminates material between the threads of the screw, thus providing an opportunity for new bone to grow through. The difference provided by the BIOSURE REGENESORB Interference Screw is more than six times greater open area available for bone in-growth in comparison to competitive interference screws.4


Allows Integration of Bone and Graft

Unlike solid interference screws, the BIOSURE REGENESORB Interference Screw’s open-architecture design allows for new bone to grow through the implant and integrate into the graft.

The new bone is integrating to an area of the graft that may not be accessed until a solid conventional interference screw begins to resorb. The result with the BIOSURE REGENESORB Interference Screw is approximately 50% restoration of bone volume by new bone within center cannulation by 12 weeks, and circumferential graft-to-bone integration as demonstrated by a preclinical ovine ACL reconstruction study.5 Several studies suggest that integration between the bone and graft plays a role in the remodeling and healing process.6–9


6x Greater Open Area for Bone In-Growth 4

BIOSURE REGENSORB Copy pic 2

Reliable Performance

The Strength of a Solid Screw

  • The BIOSURE REGENESORB Interference Screw exhibits comparable fixation strength to solid absorbable interference screws at implantation and at 26 weeks in a simulated degradation environment.11
  • The full length of the BIOSURE REGENESORB Interference Screw is supported by the BIOSURE Driver. Torsional stress is transferred off the screw and onto the driver, resulting in superior performance during insertion.12,13

Advanced Biocomposite Material

The REGENESORB Material mixture produces a biocomposite material designed to remain mechanically stablefor a minimum of six months before subsequently being absorbed and replaced by bone within 24 months. See image below.14

BIOSORB REGENESORY Copy pic 3

What makes REGENESORB Material unique is the formulation of osteoconductive component materials.15

Some competitive materials rely solely on the long-term properties of β-TCP:

  • Provides sustained bone formation over 18 months16
  • Acts primarily as a scaffold for enhancing new bone formation17

BIOSURE REGENESORB pic 4

REGENESORB Material includes a second osteoconductive material, calcium sulfate.

  • Works in early stages (4–12 weeks) of bone healing16
  • Associated with increased levels of local growth factors18

Therefore, REGENESORB Material contains dual osteoconductive components, which
have been individually shown to act during different stages in the bone healing process
and through different mechanisms of action – physical and biochemical.

Each component has been proven safe and biocompatible over decades of clinical use,
and the safety of REGENESORB Material has been confirmed through preclinical studies.19

References

BIOSURE REGENESORB is not available in markets outside the United States

References

1. Micro-CT scan of BIOSURE REGENESORB Material in ACL reconstruction ovine study at 12 weeks post-implantation. Data on file at Smith & Nephew, report NCS250.
Results of in vivo simulation have not been shown to quantitatively predict clinical performance.

2. Compared to BIOSURE HA Interference Screws. Data on file at Smith & Nephew, reports 15004843, 15002832, 15002353, 15002699.

3. In vivo animal testing has demonstrated that REGENESORB Material is bioabsorbable and is replaced by bone. Implants (9x10 mm) were implanted in ovine cancellous
bone and compared to an empty defect (9x10 mm) at 6, 12, 18, and 24 months (n=6). Micro-CT analysis demonstrated that by 24 months, bone in-growth into
this material (289.5 mm3) was significantly greater (p<0.05) than bone in-growth into an empty defect (170.2mm3) and reaches a bone volume not statistically different
from intact bone (188.2 mm3). Results of in vivo simulation have not been shown to quantitatively predict human clinical performance. Data on file at Smith &
Nephew, report 15000897.

4. CT Comparison with Arthrex Biocomposite 7x23mm and Mitek Milagro 7x23mm. Data on file at Smith & Nephew, report 15005255.

5. As demonstrated by micro-CT analysis and quantifications of bone in-growth within cannulation of implanted screw in femoral tunnel compared to undisturbed bone
in a preclinical ovine ACLR study (49.5%, stdev 12.5%), SNN Data on File NCS250, Results of in vivo simulation have not been shown to quantitatively predict clinical
performance.

6. Kuang GM, Yau WP, Lu WW et al. Osteointegration of soft tissue grafts within the bone tunnels in anterior cruciate ligament reconstruction can be enhanced.
Knee Surg Sports Traumatol Arthrosc. 2010 Aug;18(8):1038-51. doi: 10.1007/s00167-009-0910-1. Epub 2009 Sep 25.

7. The Anterior Cruciate Ligament: Reconstruction and Basic Science . Chadwick C. Prodromos, editor. Philadelphia: Saunders; 2008. ISBN: 978-1-4160-3834-4.

8. Current Concepts in ACL Reconstruction. Freddie H. Fu and Stephen B. Cohen, editors. SLACK Incorporated NJ, USA. ISBN: 978-1556428135.

9. Anterior Cruciate Ligament Reconstruction: A Practical Surgical Guide. Siebold, Rainer, Dejour, David, Zaffagnini, Stefano (Eds.) Springer Science & Business, 2014
ISBN 978-3-642-45349-6

10. Data on file at Smith & Nephew, report NCS250.

11. Compared to BIOSURE HA Interference Screws in biomechanical studies, Results between BIOSURE REGENESORB and BIOSURE HA were not statistically significant.
Data on file at Smith & Nephew, reports 15004843, 15002832, 15002353, 15002699.

12. Data on file at Smith & Nephew, report 15004843 and 15005418.

13. Compared to 7x23mm Arthrex BioComposite and 7x23mm Mitek Milagro. p<.05. Data on file at Smith & Nephew, report 15005418.

14. In vivo animal testing has demonstrated that REGENESORB Material is bioabsorbable and is replaced by bone. Implants (9x10 mm) were implanted in ovine cancellous
bone and compared to an empty defect (9x10 mm) at 6, 12, 18, and 24 months (n=6). Micro-CT analysis demonstrated that by 24 months, bone in-growth into
this material (289.5 mm3) was significantly greater (p<0.05) than bone in-growth into an empty defect (170.2mm3) and reached a bone volume not statistically different
from intact bone (188.2 mm3). Results of in vivo simulation have not been shown to quantitatively predict clinical performance. Data on file at Smith & Nephew,report 15000897.

15. Smith & Nephew White Paper 10601161 REGENESORB: Absorbable Biocomposite Material.

16. Costantino and Friedman (1994) Otolaryngol Clin North Am. 1994 Oct;27(5).

17. Ogose et al, (2006) Biomaterials Vol. 27(8).

18. Walsh et al, (2003) Clin. Orthop. Rel. Res. Vol 406, Allison Et al (2011) US Oncology and Hematology Vol 7(1).

19. Data on file at Smith & Nephew, reports 15000897, 15001194, 15000921, 15000919, NCS250.

 

Ordering Information

BIOSORB REGENESORB Interference Screw

Reference # Description
72204391  BIOSURE REGENESORB Interference Screw, 6mm x 20mm
72204394  BIOSURE REGENESORB Interference Screw, 7mm x 20mm
72204395  BIOSURE REGENESORB Interference Screw, 7mm x 25mm
72204398  BIOSURE REGENESORB Interference Screw, 8mm x 20mm
72204399  BIOSURE REGENESORB Interference Screw, 8mm x 25mm
72204401  BIOSURE REGENESORB Interference Screw, 8mm x 30mm
72204403  BIOSURE REGENESORB Interference Screw, 9mm x 20mm
72204404  BIOSURE REGENESORB Interference Screw, 9mm x 25mm
72204405  BIOSURE REGENESORB Interference Screw, 9mm x 30mm
72204408  BIOSURE REGENESORB Interference Screw, 10mm x 25mm
72204409  BIOSURE REGENESORB Interference Screw, 10mm x 30mm

Instruments
Reference # Description
7211138    Guide Wire, 1.2mm x 12" sterile (5 per box)
72201201  Guide Wire, 1.2mm x 18" sterile (5 per box)
72201887  BIOSURE Driver
72201888  BIOSURE Ratchet Driver
(requires Ratcheting Handle with Hudson Adapter 7207707)
7207707   Ratcheting Handle with Hudson Adapter

72201941 BIOSURE TAP System
Reference # Description

System includes 1 each of:
72201889 6mm BIOSURE Tap
72201890 7mm BIOSURE Tap
72201891 8mm BIOSURE Tap
72201892 9mm BIOSURE Tap
72201893 10mm BIOSURE Tap
72201887 BIOSURE Driver
72201938 BIOSURE Tap Tray

72201942 BIOSURE EASY TAP System
Reference # Description

System includes 1 each of:
72201190 6mm BIOSURE EASY Tap
72201191 7mm BIOSURE EASY Tap
72201192 8mm BIOSURE EASY Tap
72201193 9mm BIOSURE EASY Tap
72201194 10mm BIOSURE EASY Tap
72201888 BIOSURE Ratchet Driver
7207707  Ratcheting Handle with Hudson Adapter
72201939 BIOSURE EASY Tap Tray


BIOSURE REGENESORB is not available in markets outside the United States