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Q-FIX™All-Suture Anchor
FIRSTPASS™ ST Suture Passer
MULTIFIX™ S ULTRAKnotless Suture Anchor
ULTRATAPE Suture
FOOTPRINT ULTRA PK Knotless Suture Anchor
HEALICOIL™ REGENESORBSuture Anchor
HEALICOIL PKSuture Anchor
Comprehensive Product Offerings for Your Rotator Cuff Repair
Rotator Cuff Repair Solutions
Completed construct from a double row repair of a massive rotator cuff tear using HEALICOIL PK Suture Anchors loaded with ULTRATAPE and FOOTPRINT™ ULTRA PK Knotless Suture Anchors.
Insertion of a second HEALICOIL™ PK Suture Anchor into the medial aspect of the greater tuberosity.
When You Demand Performance for Your Rotator Cuff RepairOur wide array of innovative shoulder repair solutions gives surgeons a comprehensive product offering for rotator cuff repairs. From a steady starting position to a precisely controlled single or double row anchor fixation solution, we have what it takes to overcome your specific challenges.
Customizable construct options• Provided by choice of implant, suture type
and configuration based on each patient’s tear pattern and tissue and bone quality
Minimal anatomic disruption• Achieved through open architecture,
small, all-suture options, and next generation biocomposite material
Efficient, reliable repair• Accomplished with implants and
suture passers designed to reduce repair steps, including suture shuttling and bone hole preparation
Significantly More Contact Area
Contact area on pressure sensitive film for ULTRATAPE compared to two controls, measured in inches squared, with confidence intervals.
ULTR
ATA
PE
ULTR
ABR
AID
™ #2
Sutu
re
Fibe
rTap
eTM
.25
.20
.15
.10
.05
0
.21
.12.13
More repair options and expanding techniques.• Use for knotless or knotted repairs
• Available pre-loaded on HEALICOIL™ Suture Anchors
A smaller amount of material can be advantageous when passed through compromised tissue.
• 58% less material than FiberTape3
• More evenly distributed pressure3
• Fewer peak pressure points3
ULTRATAPESuture
Ultra Contact. Less Material. Make More of Your Rotator Cuff Repair
Increased tendon-to-bone contact can mean an improved repair.1,2
• 75% more contact than #2 suture3
• 60% more contact than FiberTapeTM3 (demonstrated in pre-clinical testing).
ULTRATAPE: Cross section showing smooth braid
Arthrex® FiberTapeTM: Cross section showing solid inner core
ULTRATAPE used in a rotator cuff repair
Suture Solutions
Suture and Fixation Solutions
HEALICOIL™ REGENESORBSuture Anchor
HEALICOIL PKSuture Anchor
A Unique Combination of Innovative Design and Materials Greater healing potential though open-architecture design. The HEALICOIL Suture Anchor has a distinctive open architecture that differs from solid-core implants by eliminating the material between the anchor threads. The open, vented design is intended to allow blood and bone marrow from surround-ing cancellous bone to enter the implant. A recent study in 70 subjects reported that vented suture anchors provided greater healing potential than solid, non-vented anchors at six weeks post-surgery, as measured by rotator cuff thickness.4
Greater bone ingrowth compared to Arthrex Corkscrew® FT Suture AnchorAt 18 months, μCT imaging showed HEALICOIL REGENESORB Suture Anchor had a significantly greater bone ingrowth compared to the Arthrex Corkscrew® FT Suture Anchor (54.5% ± 14.1 vs. 29.8% ± 8.8, respectively; p<0.001) in a pre-clinical ovine study.5
Micro-CT images at 12 weeks of a 5.5mm HEALICOIL PK Suture Anchor show a web of bone beginning to fill the center of the implant. Histol-ogy at the same point in time clearly demonstrates bone growing across the implant’s open architecture.
HEALICOIL PK Suture Anchor: Bone-fill at 12 weeks in a pre-clinical ovine study.
HEALICOIL REGENESORB
Arthrex Biocomposite Corkscrew® FT
S&N HEALICOIL
REGENESORB Suture Anchor
(n9)
100
90
80
70
60
50
40
30
20
10
0
Bone
Ingr
owth
(%)
Arthrex BioComposite Corkscrew® FT Suture Anchor
(n9)
Percentage of bone ingrowth at 18 mos.5
54.5%+_ 14.1
29.8%+_ 8.8
6 m
onth
s18
mon
ths
Suture and Fixation Solutions
Less material The unique open-architecture design of the HEALICOIL™ Anchor reduces the amount of implanted material in the shoulder compared to traditional, solid-core anchors, permitting easier revision when necessary.6
Durable design Even with its reduced volume of material, the HEALICOIL REGENESORB Suture Anchor meets the demanding biomechanical specifications of the most advanced surgical implants, providing the benefits of an absorbable implant with fixation strength comparable to non-absorbable PEEK implants.7
And when compared to competitive biocomposite suture anchors, its superi-or biomechanical performance includes stronger fixation security in poor- quality bone, and greater torsional strength – essential when inserting the anchor into harder bone densities.8
Greater pullout strength The extended, fully-threaded HEALICOIL anchor design provides more threaded engagement than leading competitive biocomposite anchors, delivering greater pullout strength in poor-quality, osteoporotic bone.8
Minimal size In biomechanical testing, the 4.75mm HEALICOIL REGENESORB Suture Anchor demonstrated higher pullout strength than the larger, 5.5mm competitive anchors.8
Sustained fixation strength for healing The initial strength of the HEALICOIL REGENESORB Suture Anchor is designed to hold fixation over time throughout the healing period in poor quality bone,9 withstanding typical shoulder loading forces and supporting the range of motion necessary for physical therapy and rehabilitation.
Note: Testing conducted in 5pcf bone block; 5pcf bone density is equivalent to the worst-case, poorest-quality decorticated humeral bone. (pcf = pounds per cubic feet).
S&N HEALICOIL
REGENESORB 5.5mm
40
35
30
25
20
15
10
5
0
Pullo
ut S
treng
th (l
bf)
S&N HEALICOIL
REGENESORB 4.75mm
DePuy MITEK
HEALIXtm Biocryl® Rapidetm
5.5mm
Arthrex BioComposite Corkscrew® FT
5.5mm
Anchor pullout testing8
The unique open-architecture design reduces the amount of implanted material compared to traditional, solid-core anchors, permitting easier revision when necessary6
REGENESORB Material
An advanced biocomposite absorbed and completely replaced by bone within 24 months in pre-clinical studies.10 Developed by Smith & Nephew’s Advanced Healing Technologies group, REGENESORB biocomposite material contains PLGA and dual osteoconductive components, β-TCP and calcium sulfate.
Gross anatomy and histology images of a 9x10 mm REGENESORB interference screw evaluated in a direct-in-bone sheep model. Images clearly demonstrate absorption and complete replacement by bone within 24 mos.
6 months 12 months 18 months 24 months
18-month histology snapshot of 2.3mm REGENESORB instability anchor evaluated in a direct-in-bone sheep model (viewed under partially polarized light).
Snapshot of REGENESORB material at 18 months11
Bone replacement in progress
Osteoblasts forming
new bone
More mature bone,
in the form of organized
collagen sheets (lamellar bone)
REGENESORB fragment being
absorbed and replaced
by bone
Faster absorptionHistomorphometry showed a faster absorption of HEALICOIL REGENESORB, with 70% absorption at 18 months compared with 57% for the PLLA/ß-TCP-based Arthrex BioComposite Corkscrew FT (p<0.001).12
New bone ingrowth into areas of absorped HEALICOIL REGENESORB Suture Anchor at 18 months.12
Sanderson’s Rapid Bone stain at 25X
magnification.
New bone in-growth indicat-ed by arrows.
Q-FIX™ All-Suture Anchor
Next Generation All-Suture Anchor TechnologyThe 2.8mm Q-FIX Anchor’s fixation performance and small footprint makes it a great option for rotator cuff repairs. With performance similar to traditional corkscrew anchors more than twice its size, the 2.8mm Q-FIX anchor is ideal for medial row fixation where space is limited.
Consistent deploymentQ-FIX Anchors provide consistent deployment due to the radially expanding implant design and delivery system that acts like a knot pusher.
Strong performanceThe Q-FIX Anchor delivery system, with automated suture pull to a target of 140 newtons, ensures full deployment of the implant within the bone hole.13
Streamlined techniqueImplant deployment with a turn of the dial through the drill guide streamlines implant placement.
Fixation Solutions
To insert, tap the FOOTPRINT ULTRA PK Knotless Suture Anchor preloaded with ULTRATAPE into the prepared pilot hole.
After tensioning the sutures, rotate the inserter knob clockwise to advance the inner-locking plug and securely trap the sutures within the anchor eyelet.
FOOTPRINT ULTRA PKKnotless Suture Anchor
Fixation Solutions
A Lateral Row Solution for Your Rotator Cuff Repair Available in two sizes, 4.5mm and 5.5mm, the FOOTPRINT ULTRA PK Knotless Suture Anchor accommodates up to four sutures, making it the ideal option for use in double row suture bridging repairs.
Strong fixationThe FOOTPRINT ULTRA PK Knotless Suture Anchor’s unique offset barbed geometry wings provide optimal pull-out strength for a tap-in anchor.14
Controlled repair tensionThe unique design of the FOOTPRINT ULTRA PK Knotless Suture Anchor allows for controlled tensioning, and re-tensioning, across the repair post anchor insertion.
Secure suture retention Sutures are securely retained within the anchor eyelet due to the unique inner-locking plug feature, reducing suture slippage. Suture retention in the FOOTPRINT ULTRA PK Knotless Suture Anchor is independent of bone quality.
Fixation Solutions
Multiple Fixation Options Ideal for Multi-Suture Constructs The MULTIFIX System is a family of knotless, all-PEEK, pound-in implants. The system provides multiple fixation options as well as a streamlined technique ideal in multi-suture constructs, allowing surgeons to meet the needs of a diverse patient population.
Multiple fixation optionsThe MULTIFIX System allows the surgeon to create various biomechanically stable constructs with two bone lock options.
Streamlined technique• Pound-in technique (bone hole may be required) • Suture lock with the turn of a dial • Hand tension sutures for tactile feedback
Ideal in multi-suture constructs• Accommodates up to four #2 sutures
or four ULTRATAPE Sutures.
MULTIFIX™ S ULTRAKnotless Suture Anchor
1. Load sutures using double snare 2. Insert PEEK tip into bone 3. Turn dial to lock sutures
Customizable construct options
Bone lock options
MULTIFIX P
Compression
MULTIFIX S ULTRA
Screw
Unique, double-snaring design accommodates multiple sutures.
FIRSTPASS™ STSuture Passer
Suture Passing Solutions
The Always Ready Solution for a Variety of Repair Needs The FIRSTPASS ST Suture Passer is a single-use suture passer pre-loaded with a needle and sterile packed allowing for immediate out-of-the-box use.
Pre-loaded and sterile packed for single case use• Eliminates the time and inconvenience associated
with sterilizing a reuseable suture passer
• Needle loading and unloading are no longer required
• No capital cost or instrument maintenance needed
Round, pre-curved nitinol needle • Provides added strength and reliability
• Suture is carried in a recess on the needle, which helps maintain suture integrity
Deep bite• Allows for tissue manipulation and suture passage through
cuff tissue, up to 10 mm in thickness and 18 mm in bite depth
Ability to pass MAGNUMWIRE™, ULTRABRAID™ and ULTRATAPE™ sutures• The surgeon is not limited by suture type and can
make product decisions based on the repair needs.
Surgical technique
Load suture Place the suture firmly into the suture slot on the bottom jaw of the instrument. The free tail should be short, about 2-3cm (approximately an inch).
Standard
Self-capturing
Grasp tissue Close the jaw and insert the working end of the suture passer into the surgical field, open the jaw and position around the target tissue and squeeze the lever to the tissue clamping position (first stop).
Pass and retrieve suture Deploy the needle through the tissue by using the index finger to depress the trigger, and continue to squeeze the lever as far as is required to engage a 2mm diameter loop of suture. The suture will remain engaged in the self-capture (22-4038). Allow the lever to open fully in order to retract the needle and unclamp the tissue.
Remove captured suture Manually grasp the suture. Pull down and proximal (toward the handle) to disengage the suture from the self-capture.
Designed Specifically for Rotator Cuff ProceduresReliable Reliably pass and retrieve #2 ULTRABRAID™ Suture or
ULTRATAPE, in one easy motion15
Simple Simple to load, operate and manage sutures
Innovative I nnovative design allows for tissue manipulation and suture passage through cuff tissue, up to 10mm in thickness
Ergonomic Ergonomically designed for one-handed operation and optimal maneuverability
Polymer-coated needle aids smooth passage through tissue, protecting the needle and helping to prevent breakage
References
1. Bisson LJ, Manohar LM. A biomechanical comparison of the pullout strength of No. 2 FiberWire suture and 2-mm FiberWire tape in bovine rotator cuff tendons. Arthroscopy 2010; 26(11):1463-1468.
2. Park MC, ElAttrache NS, Tibone JE, Ahmad CS, Jun BJ, Lee TQ. Part I: Footprint contact characteristics for a transosseous-equivalent rotator cuff repair technique compared with a double-row repair technique. J Shoulder Elbow: (2007 Jul-Aug; 16(4):461-8. Epub 2007 Feb 22.
3. Data on File at Smith & Nephew, report 15001847.
4. Clark TR, Guerrero EM, Song A, O’Brien MJ, Savoie FH (2016) Do Vented Suture Anchors Make a Difference in Rotator Cuff Healing. Ann Sports Med Res 3(3): 1068.
5. Data on file at Smith and Nephew, report NCS248.
6. Validation 15001193. Note: Animal data is not necessarily indicative of human clinical outcomes. These results have not been demonstrated in humans having a variety of bone quality based on specific disease states such as osteoporosis. The effect of formation of new bone on pullout strength was not shown.
7. Data on file at Smith & Nephew in reports 15001873 and 15002036.
8. Report Number 15002036 HEALICOIL Suture Anchor competitive testing. Data on file.
9. Data on file at Smith and Nephew in report 15001609.
10. 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 clinical performance. Data on file at Smith & Nephew in report 15000897.
11. In vivo animal testing has demonstrated that the composite material is bioabsorbable and is replaced by bone. Results of in vivo simulation have not been shown to quantitatively predict clinical performance. Data on file at S&N in report 15001194.
12. Data on file at Smith and Nephew, report NCS248.
13. P/N 45189 Rev F, Section 4.3 and P/N 49190-01, Section 3.5.
14. Data on file at Smith & Nephew, ITR-3679, ITR-4202, ITR-3557, ITR-3784.
15. Data on file at Smith & Nephew in report 15002182.
Self-capture door facilitates simultaneous suture passing and retrieval
Front loading slot enables quick and easy loading of suture
Suture Passing Solutions
TRUEPASS™Suture Passer
*Manufactured by:Smith & Nephew, Inc.150 Minuteman RoadAndover, MA 01810 USA
™ Trademark of Smith & Nephew. All trademarks acknowledged. ©2017 Smith & Nephew. All rights reserved. Printed in USA. 04100 V3 10/17
www.smith-nephew.comT +1 978 749 1000 US Customer Service: +1 800 343 5717
To learn more about Smith and Nephew’s rotator cuff solutions, go to www.smith-nephew.com or call your sales representative at +1 800 343 5717.
Ordering InformationULTRATAPE Suture*Reference # Description
72203896 ULTRATAPE Suture (Blue, 6 per box)72203897 ULTRATAPE Suture (Cobraid Blue, 6 per box)
ULTRATAPE Suture Passing Instrumentation*Reference # Description
72204385 ARTHRO-PIERCE™ ULTRATAPE, 35° up
HEALICOIL™ PK Suture Anchor* Pre-loaded with ULTRATAPE Suture*Reference # Description
72203981 HEALICOIL PK 4.5mm Suture Anchor with one ULTRATAPE Suture (Blue)
72203982 HEALICOIL PK 4.5mm Suture Anchor with one ULTRATAPE Suture (Cobraid Blue)
72203983 HEALICOIL PK 5.5mm Suture Anchor with one ULTRATAPE Suture (Blue) and one #2 ULTRABRAID™ Suture
72203984 HEALICOIL PK 5.5mm Suture Anchor with one ULTRATAPE Suture (Cobraid Blue) and one #2 ULTRABRAID Suture
HEALICOIL PK Suture Anchor* Pre-loaded with ULTRABRAID Suture*Reference # Description
72203378 HEALICOIL PK 4.5mm Suture Anchor with two #2 ULTRABRAID Sutures (Blue, Cobraid Blue)
72203379 HEALICOIL PK 5.5mm Suture Anchor with two #2 ULTRABRAID Sutures (Blue, Cobraid Blue)
72203380 HEALICOIL PK 5.5mm Suture Anchor with three #2 ULTRABRAID Sutures (Blue, Cobraid Blue, Cobraid-Black)
HEALICOIL PK Accessory Devices*Reference # Description
72202621 3.8mm Tapered Awl, disposable72201915 3.8mm Tapered Awl, reusable72202633 4.5mm HEALICOIL/TWINFIX™ ULTRA Threaded Dilator,
reusable72203634 5.5mm HEALICOIL/TWINFIX ULTRA Threaded Dilator,
reusable
HEALICOIL REGENESORB Suture Anchor* Pre-loaded with ULTRATAPE*Reference # Description
72203705 HEALICOIL REGENESORB 4.75mm Suture Anchor with one ULTRATAPE Suture (Blue) and one #2 ULTRABRAID Suture
72203697 HEALICOIL REGENESORB 4.75mm Suture Anchor with one ULTRATAPE Suture (Cobraid Blue) and one #2 ULTRABRAID Suture
72203708 HEALICOIL REGENESORB 5.5mm Suture Anchor with one ULTRATAPE Suture (Blue) and one #2 ULTRABRAID Suture
72203801 HEALICOIL REGENESORB 5.5mm Suture Anchor with one ULTRATAPE (Cobraid Blue) and one #2 ULTRABRAID Suture
HEALICOIL REGENESORB Suture Anchor* Pre-loaded with ULTRABRAID Suture*Reference # Description
72203704 HEALICOIL REGENESORB 4.75mm Suture Anchor with two #2 ULTRABRAID™ sutures (Blue, Cobraid Blue)
72203706 HEALICOIL REGENESORB 5.5mm Suture Anchor with two #2 ULTRABRAID sutures (Blue, Cobraid Blue)
72203707 HEALICOIL REGENESORB 5.5mm Suture Anchor with three #2 ULTRABRAID sutures (Blue, Cobraid Blue, Cobraid Black)
HEALICOIL REGENESORB Accessory Devices*Reference # Description
72203709 HEALICOIL REGENESORB 4.75mm Threaded Dilator, reusable
72203710 HEALICOIL REGENESORB 5.5mm Threaded Dilator, reusable
72203951 HEALICOIL REGENESORB 4.75mm Threaded Dilator, disposable
72203952 HEALICOIL REGENESORB 5.5mm Threaded Dilator, disposable
Q-FIX™ All-Suture Anchor**Reference # Description
25-2800 Q-FIX 2.8mm All Suture Anchor25-2810 Q-FIX 2.8mm All Suture Anchor Disposable Kit – Drill,
Drill Guide, and Obturator25-2820 Q-FIX 2.8mm All Suture Anchor Bone Punch, reusable25-2812 Q-FIX 2.8mm PATHFINDER™, reusable
FOOTPRINT ULTRA Knotless Suture Anchor*Reference # Description
72202901 FOOTPRINT Ultra PK 4.5mm72202902 FOOTPRINT Ultra PK 5.5mm72202621 3.8mm Tapered Awl, disposable72201915 3.8mm Tapered Awl, reusable
MULTIFIX™ S ULTRA Knotless Suture Anchors**Reference # Description
72290001 MULTIFIX S ULTRA 5.5mm Knotless Suture Anchor72290002 MULTIFIX S ULTRA 6.5mm Knotless Suture AnchorOM-9420 3.4mm Bone PunchOM-9220 Tapered PunchOM-9615 SPEEDSCREW™/MULTIFIX S ULTRA Insertion Guide
and Obturator Set: Insertion Guide with Obturator
FIRSTPASS™ ST Suture Passer**Reference # Description
22-4038 FIRSTPASS ST Suture Passer, Self-Capture22-4039 FIRSTPASS ST Suture Passer, Standard
TRUEPASS™ Suture Passer*Reference # Description
72203791 TRUEPASS Suture Passer, Self-Capture72203792 TRUEPASS Suture Passer, Standard72203793 TRUEPASS Disposable Needles (5 per box)
**Manufactured by:ArthroCare Corporation7000 West William Cannon DriveAustin, TX 78735 USA