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BIOSURE REGENESORB

Interference Screw

Overview

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

Bone Ingrowth
BIOSURE REGENESORB Interference Screw has an open architecture design to allow for bone to grow through the screw and attach to the graft 1

New bone is integrated into the graft in areas not previously accessed by solid conventional interference screws, resulting in circumfrential graft-to-bone integration, as demonstrated by a pre-clinical study. 4

Integration between bone and graft plays a role in the remodeling and healing process, as suggested by several studies. 5-8


Performance
BIOSORB REGENSORB Interference Screw exhibits the strength expected from a solid absorbable interference screw. 2

The full length of the 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. 10-11

 

Advanced Biocomposite Material

 

Advanced Material
REGENESORB Material is replaced by bone within 24 months in preclinical studies 3

 REGENESORB Material 2017

References

BIOSURE REGENESORB is not available in markets outside the United States

References

1. As demonstrated by micro-CT analysis and quantifications of bone ingrowth within cannulation of implanted screw in femoral tunnel compared to undisturbed bone in a preclinical ovine ACLR study (49.5%, stdev 12.5%). 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 (9x10mm) were implanted in ovine cancellous bone and compared to an empty defect (9x10mm) at 6, 12, 18 and 24 months (n=6). Micro-CT analysis demonstrated that by 24 months, bone ingrowth into this material (289.5mm3) was significantly greater (p<0.05) than bone ingrowth into an empty defect (170.2mm3) and reaches a bone volume not statistically different from intact bone (188.2mm3). Results of in vivo simulation have not been shown to quantitatively predict human clinical performance. Data on file at Smith & Nephew, report 15000897.

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

5. 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.

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

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

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

9. 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.

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

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

12. In vivo animal testing has demonstrated that REGENESORB Material is bioabsorbable and is replaced by bone. Implants (9x10mm) were implanted in ovine cancellous bone and compared to an empty defect (9x10mm) at 6, 12, 18 and 24 months (n=6). Micro-CT analysis demonstrated that by 24 months, bone ingrowth into this material (289.5mm3) was significantly greater (p<0.05) than bone ingrowth into an empty defect (170.2mm3) and reached a bone volume not statistically
different from intact bone (188.2mm3). Results of in vivo simulation have not been shown to quantitatively predict clinical performance. Data on file at Smith & Nephew, report 15000897.

13. Smith & Nephew White Paper 10601161 REGENESORB: Absorbable Biocomposite Material.
14. Data on file at Smith & Nephew, reports 15000897, 15001194, 15000921, 15000919, NCS250.
15. Costantino and Friedman. Synthetic Bone Graft Substitutes (1994) Otolaryngol Clin North Am. 1994 Oct;27(5).
16. Walsh et al, (2003) Clin. Orthop. Rel. Res. Vol 406, Allison Et al (2011) US Oncology and Hematology Vol 7(1).

Ordering Information

BIOSORB REGENESORB Interference Screw
BIOSURE REGENESORB is not available in markets outside the United States


Reference # Description

BIOSURE REGENESORB Interference Screw

72204389   BIOSURE REGENESORB Interference Screw 5mm x 20mm*
72204390   BIOSURE REGENESORB Interference Screw 5mm x 25mm*
72204391   BIOSURE REGENESORB Interference Screw 6mm x 20mm
72204392   BIOSURE REGENESORB Interference Screw 6mm x 25mm
72204393   BIOSURE REGENESORB Interference Screw 6mm x 25mm Reverse Thread

72204394   BIOSURE REGENESORB Interference Screw 7mm x 20mm
72204395   BIOSURE REGENESORB Interference Screw 7mm x 25mm
72204396   BIOSURE REGENESORB Interference Screw 7mm x 25mm Reverse Thread

72204397   BIOSURE REGENESORB Interference Screw 7mm x 30mm
72204398   BIOSURE REGENESORB Interference Screw 8mm x 20mm
72204399   BIOSURE REGENESORB Interference Screw 8mm x 25mm
72204400   BIOSURE REGENESORB Interference Screw 8mm x 25mm Reverse Thread

72204401   BIOSURE REGENESORB Interference Screw 8mm x 30mm
72204402   BIOSURE REGENESORB Interference Screw 8mm x 35mm
72204403   BIOSURE REGENESORB Interference Screw 9mm x 20mm
72204404   BIOSURE REGENESORB Interference Screw 9mm x 25mm
72204405   BIOSURE REGENESORB Interference Screw 9mm x 30mm
72204406   BIOSURE REGENESORB Interference Screw 9mm x 35mm
72204407   BIOSURE REGENESORB Interference Screw 10mm x 20mm
72204408   BIOSURE REGENESORB Interference Screw 10mm x 25mm
72204409   BIOSURE REGENESORB Interference Screw 10mm x 30mm
72204410   BIOSURE REGENESORB Interference Screw 10mm x 35mm
72204411   BIOSURE REGENESORB Interference Screw 11mm x 25mm
72204412   BIOSURE REGENESORB Interference Screw 11mm x 30mm
72204413   BIOSURE REGENESORB Interference Screw 11mm x 35mm
72204414   BIOSURE REGENESORB Interference Screw 12mm x 35mm

Reference # Description
Instruments
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
72204647  BIOSURE Driver, 5mm*
72201888  BIOSURE Ratchet Driver (requires 7207707)
7207707    Ratcheting Handle with Hudson Adapter

Reference # Description
72201941 BIOSURE TAP 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


Reference # Description
72201942 BIOSURE EASY TAP 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