SHOULDER RESTORATION SYSTEM

Y-Knot® Flex All-Suture Anchor System

Overview


80% Less Bone Removal

•  The Y-Knot Flex 1.3mm single-loaded and new 1.8mm double-loaded anchors are the smallest all-suture anchors on the market for labral repair.
•  1.3mm Y-Knot anchor compared to a 3.0mm press fit anchor.*

55% More Fixation, 30% Less Creep

•  The Y-Knot Flex anchor construct provides 360º FormFitFixation for a strong and secure repair, shown to be 55% stronger than conventional 3.0mm press-in style anchors in peer reviewed literature.

Soft Construct

•  With its all-suture design, Y-Knot Flex Anchors will not leave any hard loose anchor bodies behind in the joint.

Easy To Use

•  Color coordinated components, positive depth stops on drill bits, and slimmer drill guides for more precise anchor placement are just a few features that make the new system easy to use.

Expanded Delivery Options

•  The Y-Knot Flex System offers new curved and percutaneous delivery options. The curved guide features distal windows for a clear view of anchor insertion.
Y-Knot Flex All-Suture Anchor System Ordering Information
Y-Knot Flex All-Suture Anchor, 1.3mm - Single Loaded w/ one Strand of #2 Hi-Fi
Y1301

Y-Knot Flex All-Suture Anchor, 1.8mm - Double Loaded w/ two Strands of #2 Hi-Fi
Y1802
Y-Knot Flex Disposable Drill Bit, 1.3mm
Y13D
Y-Knot Flex Disposable Drill Bit, 1.3mm, for Hard Bone
Y13DHB
Y-Knot Flex Disposable Drill Bit, 1.8mm
Y18D
Y-Knot Flex - Slim Reusable Drill Guide, Fishmouth
Y-G001
Y-Knot Flex - Slim Reusable Drill Guide, Crown
Y-G002
Y-Knot Flex - Slim Reusable Obturator, Blunt
Y-G003
Y-Knot Flex - Slim Reusable Trocar, Sharp
Y-G004
Y-Knot Flex - Slim Reusable Drill Guide for 1.8mm anchor, Fishmouth (Optional)
Y-G005
Y-Knot Flex - Slim Reusable Drill Guide for 1.8mm anchor, Crown (Optional)
Y-G006
Y-Knot Flex - Reusable Curved Drill Guide
Y-CG00
Y-Knot Flex - Reusable Curved Drill Guide for 1.8mm anchor (Optional)
Y-CG01
Y-Knot Flex - Disposable Flexible Obturator, Blunt
Y-OBT1
Y-Knot Flex - Disposable Flexible Trocar, Sharp
Y-OBT2
Y-Knot Flex - Disposable Percutaneous Pack for Y-G00x Slim Reusable Guides
Y-PERC
Y-Knot Flex - 1.3mm Disposable Percutaneous Pack with T-Guide
Y-PERC13
Y-Knot Flex - 1.8mm Disposable Percutaneous Pack with T-Guide
Y-PERC18
Instability Instrument Tray
C6178


* Data on file
* Barber, FA. et al. Cyclic Loading Biomechanical Analysis of the Pullout Strengths of Rotator Cuff and Glenoid Anchors: 2013 Update. Arthroscopy. 2013; 29:832-844.
* Barber, FA. et al. Suture Anchor Materials, Eyelets, and Designs: 2008 Update. Arthroscopy. 2008; 24:895-867.

Product Details


Surgical Procedures

SLAP Lesion

Y-Knot® Flex all-suture anchors are used to reattach soft tissue to bone in surgical procedures including, but not limited to: SLAP Lesion

•  SLAP (Superior Labrum, Anterior to Posterior)
•  Bankart (Anterior, Inferior labrum)
•  Reverse Bankart (Posterior, Inferior Labrum)
•  Biceps Tenodesis


Product Description

The Y-Knot® utilizes an ~3mm-wide, flat-braided Hi-Fi® suture construct as an anchor body with one or two #2 Hi-Fi® Sutures interthreaded. The anchor is inserted into a 1.3mm (for single-loaded) or 1.8mm (for double-loaded) pilot hole. The #2 Hi-Fi suture limbs are then pulled back to set the anchor: it compresses vertically and expands laterally, and becomes seated in the bone. The Y-Knot® fixates circumferentially within the pilot hole for a more secure repair.

Put Simply: We put more material in a smaller hole for a more secure repair achieved by 360° FormFit Fixation.

Soft All-Suture Small 1.3mm/1.8mm Secure 360 FormFit Fixation

SOFT
(All-Suture)

SMALL
(1.3mm / 1.8mm)

SECURE
(360° FormFit Fixation)


Performance Testing

Pull-out strength comparison (in Newtons) of commonly used labral repair anchors. Reported by Dr. Alan Barber in peer-reviewed literature.



Despite being the smallest of these commonly used labral repair anchors, the Y-Knot Flex 1.3mm anchor outperforms the others with 250N of pull-out strength. In-house testing of the 1.8mm showed even higher pull-out strength at 380N.*


The Y-Knot outperforms competing all-suture anchors with less than 1mm displacement under cyclic loading.*


Displacement (aka “creep”) is what surgeons are frequently concerned with when they question the strength of an all-suture anchor repair. E.g. “It feels strong when I insert the anchor, but how do I know it won’t migrate over time?” The Y-Knot anchor outperforms the Juggerknot when it comes to this critical factor.


Instrumentation

Like other labral repair anchor systems, the instrumentation for the Y-Knot Flex system is comprised of a drill bit to produce a pilot hole, drill guides to aid in drilling and anchor insertion, and obturators and trocars to facilitate introduction of the drill guides into the joint. The flexibility of the system provides unprecedented surgical delivery options beyond the basics, including curved and percutaneous approaches to the repair site.



Drill Bits
Each drill bits is flexible, made of Nitinol, and has a plastic disc at the proximal end to ensure proper drilling depth (21mm). The disc is color-coded to the corresponding anchor.


Standard Instrumentation
Reusable fishmouth and crown-tipped drill guides are available for the Y-Knot Flex. These have robust shafts, but are slimmed down at the tip to enable precise positioning of the drill bit and anchor.

Curved Delivery Instruments
A reusable guide with a distal curve may provide your surgeon improved access to the repair site, especially for posterior SLAP and inferior Bankart repairs. It may also provide for more perpendicular approaches to the glenoid. The guide has windows optimally placed on the guide.

Percutaneous Delivery Packs
A series of options are available to introduce drill guides percutaneously (directly through the skin without use of a separate cannula). The Y-PERC consists of a spinal needle, guide wire, and a switching stick over which the reusable Y-Knot Flex Guides can be placed.

In addition to the spinal needle, guide wire, and switching stick, Y-PERC13 and Y-PERC18 each contain a separate disposable percutaneous drill guide with a T-handle that is sized specifically to the 1.3mm or 1.8mm anchor, respectively. These T-guides can be used with the provided trocar stylet to insert the drill guide directly into the joint in a single step. They can also be used with the provided cannulated stylet to be inserted directly over the guide wire.




19 Barber, FA. et al. Biomechanical Analysis of Pullout Strengths of Rotator Cuff and Glenoid Anchors: 2011 Update. Arthroscopy. 2011; 27:895-905
20 Barber, FA. et al. Suture Anchor Materials, Eyelets, and Designs: 2008 Update. Arthroscopy. 2008; 24:895-867
21 Barber, FA. et al. Cyclic Loading Biomechanical Analysis of Pullout Strengths of Rotator Cuff and Glenoid Anchors: 2013 Update. Arthroscopy. 2013; 29:832-844.
* Data on file

Features & Benefits


Feature Benefit Clinical Relevance
Small sizes
- 1.3mm single-loaded
- 1.8mm double-loaded
Requires less bone removal when drilling pilot hole*
Enables more points of fixation where they are needed most
•  Maintains structural integrity of glenoid/acetabular rim
•  Preserves natural anatomy
•  Affords better revision options (can use a smaller bail-out anchor)
Enables surgeon to place anchors where he/she would like them for a more optimal repair7
Anchor is comprised entirely of Hi-Fi® Suture No hard-loose bodies in the joint if anchor is pulled out
Stronger than polyester*
Less risk for articular damage in the joint after surgery if anchor dislodges
More strength and resistance to breakage in the repair
360o FormFit Fixation High pull-out strength*
Low displacement (creep) under cyclic loading*
Low risk of exceeding 5mm displacement (clinical failure)
Curved Delivery Enables more perpendicular anchor insertion
Improves access to difficult-to-reach areas
Enables surgeon to place anchors where he/she would like them, especially for inferior Bankart and posterior SLAP anchors.
Percutaneous Delivery Enables creation of additional entry points and angles without a full-sized portal Provides surgeon additional minimally invasive approach options.
Hi-Fi® suture Single or double-loaded options
Does not have a solid core (unlike Fiberwire)
Completely non-absorbable (unlike Orthocord)
•  Supports surgical techniques requiring one or two stitches from a single anchoring point
•  Results in lower knot stacks, which may reduce risk of humeral head abrasion and intra-articular irritation
•  Less abrasive on surgeon hands and soft tissue8
Repair construct will not loosen after partial absorption of suture



7 Jost PW, Khair MM, Chen DX, Wright TM, Kelly AM, Rodeo SA, Suture number determines strength of rotator cuff repair. J Bone Joint Surg Am. 2012 Jul 18; 94 (14): e1001-e1007
8 Wust, Daniel M, et al. Mechanical and Handling Properties of Braided Polyblend Polyethylene Suture in Comparison to Braided Polyester and Monofilament Polydioxanone Sutures. Arthroscopy 2006; 22:1146-1153.

Specifications


Y-Knot 1.8mm Anchor

Each Y-Knot® Flex anchor is loaded between the tines of an inserter at the time of manufacturing. This is a precision process; the anchor should not be reloaded if it becomes dislodged from the device.

Features All-Suture (Hi-Fi® suture, UHMWPE), 360° FormFit Fixation
Technique Drill pilot hole, Tap-in anchor, Pull suture strands to set, Complete repair
Instrumentation Options Crown, fishmouth, and curved guides; Percutaneous delivery packs
Y-Knot Flex 1.3mm Y-Knot Flex 1.8mm
Pilot Hole Diameter 1.3mm 1.8mm
Drill Depth 21mm 21mm
Pull-out strength 250N (porcine)5 380N (porcine)6
Sutures Single-loaded with #2 Hi-Fi® Suture Double-loaded with #2 Hi-Fi® Suture
Handle Color black
Y-Knot 1.3mm Anchor
white
Y-Knot 1.3mm Anchor
Identifying marks on drill bit Black ring stop
Y-Knot 1.3mm Anchor
White ring stop
Y-Knot 1.3mm Anchor



5 Barber, FA. et al. Cyclic Loading Biomechanical Analysis of Pullout Strengths of Rotator Cuff and Glenoid Anchors: 2013 Update. Arthroscopy. 2013; 29:832-844.
6 Data on file