Anchorflex with Disposable Applicator
Anchorflex with Disposable Applicator
Description
The commercial models that make up the Flexible Anchor family with disposable applicator are classified as surgically invasive implantable medical products for long-term use. It consists of a flexible suture anchor attached to one or more non-absorbable sutures, preloaded into an insertion device.
The implants have diameter variations to provide the surgeon with a range of choices for the different application sites, which are: Ø1.0, Ø1.4, Ø2.3 and Ø2.5 mm.
The main advantages of using this type of flexible anchor are that it allows the placement of several anchors in a given area with additional fixing points; provides greater contact between the bone and soft tissues; allows the anchor to be placed as close as possible to the joint surface; it is less invasive, as it requires a smaller pilot hole than traditional anchors (metallic or polymeric). By allowing the anchors to be placed in closer proximity, stress on the repaired tissue is reduced, potentially improving bone healing success rates.
The implant is characterized as a single composite product, that is, the flexible anchor, the applicator and the suture thread (with or without needle), cannot be sold separately.
The implants have diameter variations to provide the surgeon with a range of choices for the different application sites, which are: Ø1.0, Ø1.4, Ø2.3 and Ø2.5 mm.
The main advantages of using this type of flexible anchor are that it allows the placement of several anchors in a given area with additional fixing points; provides greater contact between the bone and soft tissues; allows the anchor to be placed as close as possible to the joint surface; it is less invasive, as it requires a smaller pilot hole than traditional anchors (metallic or polymeric). By allowing the anchors to be placed in closer proximity, stress on the repaired tissue is reduced, potentially improving bone healing success rates.
The implant is characterized as a single composite product, that is, the flexible anchor, the applicator and the suture thread (with or without needle), cannot be sold separately.
ANVISA
80083650087
Components and codes
39 items
Indications
Flexible anchors are indicated for reconstructions of soft tissues to bone in the human body, in hand and shoulder surgeries. The surgical procedure can be performed using the conventional (open) or arthroscopic (closed) surgical technique.
The success of the procedure is linked to the correct selection, positioning and fixation of the implants, which is the responsibility of the doctor who evaluates the patient and decides which implants should be used. It is also linked to strict compliance with post-operative care recommended by the responsible doctor.
Specific indications by region of application:
Anchor 1.0mm – Hand
Reconstruction of collateral ligaments;
Reconstruction of the scaphoid-lunar ligament;
Reconstruction of the ulnar or lateral collateral ligament;
Reconstruction of the flexor and extensor tendons in the joints of all fingers.
Anchor 1.4mm, 2.3mm and 2.5mm – Shoulder
Rotator Cuff Injury;
Glenohumeral Stabilization;
Capsulolabral reconstruction.
The selection criteria for the type and size of implants to be used will depend on the condition of the bone and the technique to be adopted to carry out the procedure. These conditions are the responsibility of the doctor who evaluates the patient and decides which implants should be used.
The implants were designed for use in the circumstances described above, so any other uses are considered contraindicated.
The success of the procedure is linked to the correct selection, positioning and fixation of the implants, which is the responsibility of the doctor who evaluates the patient and decides which implants should be used. It is also linked to strict compliance with post-operative care recommended by the responsible doctor.
Specific indications by region of application:
Anchor 1.0mm – Hand
Reconstruction of collateral ligaments;
Reconstruction of the scaphoid-lunar ligament;
Reconstruction of the ulnar or lateral collateral ligament;
Reconstruction of the flexor and extensor tendons in the joints of all fingers.
Anchor 1.4mm, 2.3mm and 2.5mm – Shoulder
Rotator Cuff Injury;
Glenohumeral Stabilization;
Capsulolabral reconstruction.
The selection criteria for the type and size of implants to be used will depend on the condition of the bone and the technique to be adopted to carry out the procedure. These conditions are the responsibility of the doctor who evaluates the patient and decides which implants should be used.
The implants were designed for use in the circumstances described above, so any other uses are considered contraindicated.
Materials
Polyester / UHMWPE Suture Thread
Components and codes
| Code | Description | ANVISA | Qty |
|---|---|---|---|
| 0114001-013 | ANCHORFLEX 1,0MM MINI, 1 FIO USP#2-0 | 80083650087 | 1 |
| 0114011-013 | ANCHORFLEX 1,0MM MINI, 1 FIO USP#2-0 C/ 1 AGULHA | 80083650087 | 1 |
| 0114021-013 | ANCHORFLEX 1,0MM MINI, 1 FIO USP#2-0 C/ 2 AGULHAS | 80083650087 | 1 |
| 0114001-415 | ANCHORFLEX 1,4MM, 1 FIO USP#2 STD | 80083650087 | 1 |
| 0114011-415 | ANCHORFLEX 1,4MM, 1 FIO USP#2 HC | 80083650087 | 1 |
| 0114021-415 | ANCHORFLEX 1,4MM, 1 FIO USP#2 HL | 80083650087 | 1 |
| 0114031-415 | ANCHORFLEX 1,4MM, 1 FIO USP#2 C/ 1 AGULHA STD | 80083650087 | 1 |
| 0114041-415 | ANCHORFLEX 1,4MM, 1 FIO USP#2 C/ 1 AGULHA HC | 80083650087 | 1 |
View all (39)
| Code | Description | ANVISA | Qty |
|---|---|---|---|
| 0114001-013 | ANCHORFLEX 1,0MM MINI, 1 FIO USP#2-0 | 80083650087 | 1 |
| 0114011-013 | ANCHORFLEX 1,0MM MINI, 1 FIO USP#2-0 C/ 1 AGULHA | 80083650087 | 1 |
| 0114021-013 | ANCHORFLEX 1,0MM MINI, 1 FIO USP#2-0 C/ 2 AGULHAS | 80083650087 | 1 |
| 0114001-415 | ANCHORFLEX 1,4MM, 1 FIO USP#2 STD | 80083650087 | 1 |
| 0114011-415 | ANCHORFLEX 1,4MM, 1 FIO USP#2 HC | 80083650087 | 1 |
| 0114021-415 | ANCHORFLEX 1,4MM, 1 FIO USP#2 HL | 80083650087 | 1 |
| 0114031-415 | ANCHORFLEX 1,4MM, 1 FIO USP#2 C/ 1 AGULHA STD | 80083650087 | 1 |
| 0114041-415 | ANCHORFLEX 1,4MM, 1 FIO USP#2 C/ 1 AGULHA HC | 80083650087 | 1 |
| 0114051-415 | ANCHORFLEX 1,4MM, 1 FIO USP#2 C/ 1 AGULHA HL | 80083650087 | 1 |
| 0114061-415 | ANCHORFLEX 1,4MM, 1 FIO USP#2 C/ 2 AGULHAS STD | 80083650087 | 1 |
| 0114071-415 | ANCHORFLEX 1,4MM, 1 FIO USP#2 C/ 2 AGULHAS HC | 80083650087 | 1 |
| 0114081-415 | ANCHORFLEX 1,4MM, 1 FIO USP#2 C/ 2 AGULHAS HL | 80083650087 | 1 |
| 0114001-423 | ANCHORFLEX 1,4MM, 2 FIOS USP#2-0 STD | 80083650087 | 1 |
| 0114011-423 | ANCHORFLEX 1,4MM, 2 FIOS USP#2-0 HC | 80083650087 | 1 |
| 0114021-423 | ANCHORFLEX 1,4MM, 2 FIOS USP#2-0 HL | 80083650087 | 1 |
| 0114031-423 | ANCHORFLEX 1,4MM, 2 FIOS USP#2-0 C/ 2 AGULHAS STD | 80083650087 | 1 |
| 0114041-423 | ANCHORFLEX 1,4MM, 2 FIOS USP#2-0 C/ 2 AGULHAS HC | 80083650087 | 1 |
| 0114051-423 | ANCHORFLEX 1,4MM, 2 FIOS USP#2-0 C/ 2 AGULHAS HL | 80083650087 | 1 |
| 0114061-423 | ANCHORFLEX 1,4MM, 2 FIOS USP#2-0 C/ 4 AGULHAS STD | 80083650087 | 1 |
| 0114071-423 | ANCHORFLEX 1,4MM, 2 FIOS USP#2-0 C/ 4 AGULHAS HC | 80083650087 | 1 |
| 0114081-423 | ANCHORFLEX 1,4MM, 2 FIOS USP#2-0 C/ 4 AGULHAS HL | 80083650087 | 1 |
| 0114002-325 | ANCHORFLEX 2,3MM, 2 FIOS USP#2 STD | 80083650087 | 1 |
| 0114012-325 | ANCHORFLEX 2,3MM, 2 FIOS USP#2 HC | 80083650087 | 1 |
| 0114022-325 | ANCHORFLEX 2,3MM, 2 FIOS USP#2 HL | 80083650087 | 1 |
| 0114032-325 | ANCHORFLEX 2,3MM, 2 FIOS USP#2 C/ 2 AGULHAS STD | 80083650087 | 1 |
| 0114042-325 | ANCHORFLEX 2,3MM, 2 FIOS USP#2 C/ 2 AGULHAS HC | 80083650087 | 1 |
| 0114052-325 | ANCHORFLEX 2,3MM, 2 FIOS USP#2 C/ 2 AGULHAS HL | 80083650087 | 1 |
| 0114062-325 | ANCHORFLEX 2,3MM, 2 FIOS USP#2 C/ 4 AGULHAS STD | 80083650087 | 1 |
| 0114072-325 | ANCHORFLEX 2,3MM, 2 FIOS USP#2 C/ 4 AGULHAS HC | 80083650087 | 1 |
| 0114082-325 | ANCHORFLEX 2,3MM, 2 FIOS USP#2 C/ 4 AGULHAS HL | 80083650087 | 1 |
| 0114002-535 | ANCHORFLEX 2,5MM, 3 FIOS USP#2 STD | 80083650087 | 1 |
| 0114012-535 | ANCHORFLEX 2,5MM, 3 FIOS USP#2 HC | 80083650087 | 1 |
| 0114022-535 | ANCHORFLEX 2,5MM, 3 FIOS USP#2 HL | 80083650087 | 1 |
| 0114032-535 | ANCHORFLEX 2,5MM, 3 FIOS USP#2 C/ 3 AGULHAS STD | 80083650087 | 1 |
| 0114042-535 | ANCHORFLEX 2,5MM, 3 FIOS USP#2 C/ 3 AGULHAS HC | 80083650087 | 1 |
| 0114052-535 | ANCHORFLEX 2,5MM, 3 FIOS USP#2 C/ 3 AGULHAS HL | 80083650087 | 1 |
| 0114062-535 | ANCHORFLEX 2,5MM, 3 FIOS USP#2 C/ 6 AGULHAS STD | 80083650087 | 1 |
| 0114072-535 | ANCHORFLEX 2,5MM, 3 FIOS USP#2 C/ 6 AGULHAS HC | 80083650087 | 1 |
| 0114082-535 | ANCHORFLEX 2,5MM, 3 FIOS USP#2 C/ 6 AGULHAS HL | 80083650087 | 1 |