training presentation inion fixon™ ti suture anchor · 2020. 1. 27. · training presentation...
TRANSCRIPT
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
4.5x15.0 mm Rotator cuff
5.5x16.2 mm Rotator cuff
Inion FixOn™ Ti Suture Anchor
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-4502 Inion FixOn™ 4.5 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-5502 Inion FixOn™ 5.5 mm Ti Suture Anchor w/two (2) 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
Inion FixOn™ Ti Suture Anchor
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).
Inion FixOn™ Ti Suture Anchor
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
Inion FixOn™ Ti Suture Anchor
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)
Inion FixOn™ Ti Suture Anchor
Comparison to predicate devices
Minimum knot-pull tensile strength requirement
Inion FixOn™ Ti Suture Anchor
Comparison to predicate devices
The 2.0 mm Inion FixOn™ Ti Suture Anchor has an own drill bit (Ø 1.2mm)
Inion FixOn™ Ti Suture Anchor
Product portfolio – Instruments
INS-9637 Drill bit 1.2mm
2.0mm anchor FOT-2001
Inion FixOn™ Ti Suture Anchor
Product portfolio – Instruments
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™ Ti Suture Anchor
Product portfolio – Instruments
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
Inion FixOn™ Ti Suture Anchor
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!