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