Training Presentation Inion FixOn™ Ti Suture Anchor · 2020. 1. 27. · Training Presentation...

Training Presentation Inion FixOn™ Ti Suture Anchor

October 29th, 2019

Inion FixOn™ Ti Suture Anchor

Product portfolio

Size Key indication

2.0x7.0 mm Hand

2.8x8.8 mm Shoulder instability

3.5x12.4 mm Rotator cuff




Product portfolio

Material: 100% Ti6Al4V ELI 90 w-% Titanium, 6 w-% Aluminium, 4 w-% Vanadium ELI = Extra Low Interstitials = High purity

Ref No Handle Color Product description USP#

FOT-2001 Inion FixOn™ 2.0 mm Ti Suture Anchor w/one (1) Suprabraid™ suture (#2-0, metric 3) 2-0

FOT-2801 Inion FixOn™ 2.8 mm Ti Suture Anchor w/one (1) Suprabraid™ suture (#2, metric 5), long shaft 2

FOT-3502 Inion FixOn™ 3.5 mm Ti Suture Anchor w/two (2) Suprabraid™ sutures (#2, metric 5) 2


FOT-4503 Inion FixOn™ 4.5 mm Ti Suture Anchor w/three (3) Suprabraid™ sutures (#2, metric 5) 2


FOT-5503 Inion FixOn™ 5.5 mm Ti Suture Anchor w/three (3) Suprabraid™ sutures (#2, metric 5) 2


INTENDED USE

INION FixOn™ Ti Suture Anchors are intended to reattach soft tissue to bone in orthopedic surgical operations (i.e. arthroscopic or open surgical procedures) in knee, shoulder, elbow, ankle, foot, hand and wrist where the anchor size is appropriate in the presence of appropriate postoperative immobilization throughout the healing period.

Depth markings for anchor insertion depth

2.0 mm anchor (only distal depth marking)

2.8 mm anchor (distal and proximal depth markings)

3.5/4.5/5.5 mm anchors (only distal depth marking)

Depth marking with Guide

Depth markings

Depth marking

Suture alignment markings (distal)

Suture alignment marking for one suture

Suture alignment markings for two and three sutures

Suture alignment markings

One suture Suture aligned with the continuous line etch marking.

Two sutures The first suture is aligned with continuous line etch marking (T=top). The second suture is aligned with the dashed line etch marking (B=bottom).

Three sutures The first and third sutures are aligned with continuous line etch marking (T). The second suture is aligned with the dashed line etch marking (B).


Suprabraid™ Sutures UHMWPE #2-0 and #2 Sutures (Ultra-high molecular weight

polyethylene) Non-absorbable

Blue: UHMWPE with colorant Chromium-Cobalt-Aluminium Oxide White/Black: Cobraid of UHMWPE and black nylon White: UHMWPE

Blue

White/Black

White

Suprabraid™ Suture

Reference: Product brochure, ForceFiber® Sutures and Braids, 2017, Teleflex Medical OEM

SuprabraidTM

SuprabraidTM


Comparison to predicate devices

Anchors were loaded from 2 N to 15 N (2.0 mm anchors) and from 10 N to 60 N (2.8 mm and 3.5 mm anchors)



Minimum knot-pull tensile strength requirement

The 2.0 mm Inion FixOn™ Ti Suture Anchor has an own drill bit (Ø 1.2mm)


Product portfolio – Instruments

INS-9637 Drill bit 1.2mm

2.0mm anchor FOT-2001



INS-9638

INS-9639

FOT-2801

Guide

Awl

Awl and Guide are used with 2.8mm anchor with long shaft driver.

Awl and Guide can be used to prepare the implantation site on hard bone conditions also with large diameter anchors (3.5/4.5/5.5 mm). Notice: 3.5/4.5/5.5 mm anchors can not be implanted through the Guide.



Inion FixOn™ Instruments are placed in the second layer (INS-9640) of the Inion® Shoulder instrument tray (INS-9619)

Inion FixOnTM Ti suture anchor

Insertion technique

Anchor insertion steps

1. A) Gently punch the proximal end of 3.5/4.5/5.5 mm anchor driver to create pilot hole. If the bone is hard, prepare the hole with the Awl and Guide. B) Prepare the pilot hole with the Drill bit for 2.0 mm anchor. C) Prepare the pilot hole with the Awl and Guide for 2.8 mm anchor. Notice: The surgeon determines the site preparation method after the evaluation of the bone quality.

2. Insert the anchor into the pilot hole. Maintain axial alignment. 3. Rotate the driver clockwise. Apply small amount of force towards the pilot hole. 4. Continue insertion until the distal depth mark is just below the bone surface. 5. Align the vertical etch marks to adjust the sutures in desired position. 6. Release sutures from the driver handle. 7. Slowly remove the driver. 8. Apply tension to the sutures to test the fixation of the anchor and to test suture

sliding. 9. Suture passing through soft tissue 10. Suture knotting and suture cutting

Inion FixOn Ti suture anchor insertion

1. A) Gently punch the proximal end of 3.5/4.5/5.5 mm anchor driver to create pilot hole. If the bone is hard, prepare the hole with

the Awl and Guide

Inion FixOn Ti suture anchor insertion (for Ø 2.0 mm anchor)

1. B) Prepare the hole with the Ø1.2 Drill bit (INS-9637) for 2.0 mm anchor.

Inion FixOn Ti suture anchor insertion (for Ø 2.8 mm anchor)

1. C) Prepare the hole with the Awl and Guide for 2.8 mm anchor. • Insert the drill guide in correct location on the bone. • Insert the Awl in the Drill guide. • Punch the Awl in the bone with mallet

Guide

Awl Mallet

Anchor insertion

1. Insert the anchor into the pilot hole. Maintain axial alignment. 2. Rotate the driver clockwise. Apply small amount of force towards the pilot hole. 3. Continue insertion until the distal depth mark is just below the bone surface. 4. Align the vertical etch marks to adjust the sutures in desired position.

Distal depth mark

Anchor insertion

• Release sutures from the driver handle. • Slowly remove the driver.

Anchor insertion

Apply tension to the sutures to test the fixation of the anchor and to test suture sliding.

Removal of the anchor

If it becomes necessary to remove the anchor from the bone, do not release the sutures and/or driver from the anchor. Rotate the driver counterclockwise to remove the anchor.

If the driver is already removed, first pass the sutures through the driver shaft and then re-engage the driver with the anchor head. Rotate the driver counterclockwise to remove the anchor.

Inion® Shoulder Instrument Set for arthroscopic procedures

Inion® Shoulder Instrument for arthroscopic procedures

Inion® Shoulder instrument set and tray INS-9620

Inion® Shoulder instrument tray INS-9640 (= 2nd level tray for Inion FixOn™ instruments)

Inion® Shoulder Instrument Set Suture management instruments

Suture grasper

Suture passer, 45˚

Suture cutter

Crochet hook

Inion® Shoulder Instrument Set Bone and tissue preparation instruments

Tissue grasper

Glenoid rasp

Tissue elevator

Inion® Shoulder Instrument Set Other instruments

Knot pusher

Switching stick

Shoulder instrument set – order information

Ref-number Product description Package

INS-9610 Suture grasper 1 INS-9611 Tissue grasper 1 INS-9612 Knot pusher 1 INS-9613 Glenoid rasp 1 INS-9614 Tissue elevator 1 INS-9615 Suture passer, 45˚ 1 INS-9616 Crochet hook 1 INS-9617 Switching stick 1 INS-9618 Suture cutter 1 INS-9619 Shoulder instrument tray 1 INS-9620 Shoulder instrument set and tray 1

Inion FixOnTM Ti suture anchor

Surgical technique Rotator cuff repair

Insert the anchor according the instructions

Notice: Same technique is applied for all Inion FixOnTM Suture anchors in rotator cuff repair


Benefits Excellent fixation strength

The Inion FixOn™ Ti Suture Anchors provide safe and reliable fixation for orthopedic surgical operations in knee, shoulder, elbow, ankle, foot, hand and wrist.

High-quality anchor material The suture anchors are made of a high-purity titanium alloy

(Ti6Al4V ELI). Strong, clearly visible sutures (white/striped/blue)

Suprabraid™ sutures are made of strong, ultrahigh molecular weight polyethylene (UHMWPE) that is easy to knot and handle.

Anchors are provided with #2 (5 metric) sutures, except for the Ø2.0 mm anchor which is provided with #2-0 (3 metric) suture.

Fast and easy insertion The Ø3.5, Ø4.5, and Ø5.5 mm suture anchors can be simply

inserted with a “punch and drive” technique

Surgical Solutions!

Training Presentation Inion FixOn™ Ti Suture Anchor · 2020. 1. 27. · Training Presentation...

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