ACUFEX TAG BIOABSORBABLE ANCHORS

K961555 · Acufex Microsurgical, Inc. · JDR · Jul 10, 1996 · Orthopedic

Device Facts

• Record ID: K961555
• Device Name: ACUFEX TAG BIOABSORBABLE ANCHORS
• Applicant: Acufex Microsurgical, Inc.
• Product Code: JDR · Orthopedic
• Decision Date: Jul 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TAG® Bioabsorbable Anchors are intended to be used to secure suture to bone, thereby facilitating the reattachment of soft tissue.

Device Story

Wedge and rod-shaped bioabsorbable suture anchors; implanted into bone to secure suture for soft tissue-to-bone reattachment. Used in foot, ankle, and elbow orthopedic surgeries. Operated by surgeons. Anchors provide mechanical fixation; pull-out strength equivalent to non-absorbable predicates. Benefit: facilitates soft tissue repair while eliminating need for permanent implant removal.

Clinical Evidence

Bench testing only. Pull-out strength compared to predicate devices in cadaveric tibia, foot, ankle, and elbow models. Results show pull-out strength is equivalent to predicates and exceeds worst-case clinical loads for specified indications. Repair strengths in foot and ankle are equivalent to standard suture repair techniques.

Technological Characteristics

Bioabsorbable suture anchors; wedge and rod geometry. Sizes: 2.0mm, 3.0mm, 3.7mm. Delivery via drill driver or drill driver delivery sleeve. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for soft tissue to bone fixation in surgical repair of injuries in the foot, ankle, and elbow. Specific sizes: 3.7mm Rod II, 3.7mm Wedge, 3.0mm Wedge (foot, ankle, elbow); 3.0mm Wedge Mini-TAG, 2.0mm Wedge Mini-TAG (foot, ankle).

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Acufex TAG Anchors (Smith & Nephew Endoscopy)
• Mitek Mini GII anchors (Mitek Surgical Products)

Submission Summary (Full Text)

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Smith & Nephew Endoscopy
130 Forbes Boulevard
Mansfield MA 02048 U.S.A.
Telephone [phone]
Fax [phone]

JUL 10 1996

Smith & Nephew

## Statement

This Summary Of 510(K) Safety And Effectiveness Information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92

The Assigned 510(K) Number Is : K961555

This Summary was prepared on: April 18, 1996

| Submitter | Smith & Nephew Endoscopy, Inc.
130 Forbes Boulevard
Mansfield, Ma 02048 |
| --- | --- |
| Company Contact | Amy Walters
Clinical/Regulatory Manager
[phone] |
| Device Name | Trade Name: Acufex® TAG and Mini-TAG Bioabsorbable Anchors
Common Name: Suture Anchors
Classification Name: Suture Retention Device - Orthopaedic Use |
| Device description | The Acufex TAG Bioabsorbable Anchors are wedge-and rod shaped, sterile suture anchors, with a hole through which suture is threaded. the tag anchors are implanted into bone, burying and anchoring the implant and attached suture, which can be used to reattach and secure soft tissue, such as ligaments and tendons.

Three sizes of the devices will be used in the foot, ankle and elbow applications, the Tag 3.7mm Wedge and Rod II and 3.0mm and 2.0mm Wedge Anchors. |

465
BACUFEX®
NOYONICS
BIMAGES

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Intended use

The TAG® Bioabsorbable Anchors are intended to be used to secure suture to bone, thereby facilitating the reattachment of soft tissue.

Indications statement

The TAG® Bioabsorbable 3.7mm Rod, 3.7mm and 3.0mm Wedge Anchors are indicated for use in soft tissue to bone fixation in the surgical repair of injuries in the foot, ankle and elbow. These additional indications employ the following screw types and sizes:

| Size/Style | Indication |
| --- | --- |
| 3.7mm Rod II | Foot, ankle, elbow |
| 3.7mm Wedge | Foot, ankle, elbow |
| 3.0mm Wedge | Foot, ankle, elbow |
| 3.0mm Wedge Mini-TAG | Foot, ankle |
| 2.0mm Wedge Mini-TAG | Foot, ankle |

Substantial Equivalence

The Acufex® Mini-TAG and TAG Bioabsorbable Anchors are intended for use as a suture anchor in repairs of soft tissue of the foot, ankle and elbow. Acufex® Mini-TAG and TAG Bioabsorbable Anchors are similar in design, function, and intended use to other devices currently marketed and in commercial distribution, namely Acufex Tag Anchors (Smith & Nephew Endoscopy, Mansfield, MA), and Mitek Mini GII anchors (Mitek Surgical Products, Norwood, MA).

Risks to health have been addressed through the specified materials, processing controls, quality assurance, and compliance to the medical device good manufacturing practices regulations.

The table below summarizes key features of the Bioabsorbable TAG Anchors and the substantially equivalent Mitek Mini GII Anchors and Acufex TAG (non-absorbable) Anchors:

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Comparison Chart: Substantially Equivalent Bone Suture Anchors

| | Acufex Bioabsorbable TAG Anchors | | | Acufex TAG Anchors (non-absorbable) | | Mitek Anchors |
| --- | --- | --- | --- | --- | --- | --- |
| | 3.7mm Wedge and Rod | 3.0mm Wedge (Mini-TAG and TAG) | Mini-TAG 2.0mm Wedge | 3.7mm Wedge and Rod | 3.0mm Wedge | Mini-GII |
| Characteristic Intended Use | facilitate soft tissue to bone reattachment | facilitate soft tissue to bone reattachment | facilitate soft tissue to bone reattachment | facilitate soft tissue to bone reattachment | facilitate soft tissue to bone reattachment | facilitate soft tissue to bone reattachment |
| Indications for Use | expanded to include foot, ankle and elbow repairs | TAG: expanded to include foot, ankle and elbow repairs | expanded to include foot and ankle repairs | expanded to include foot, ankle and elbow repairs | expanded to include foot, ankle and elbow repairs | tissue to bone repairs in the foot, ankle and elbow. |
| | | Mini-TAG: expanded to include foot and ankle repairs | | | | |
| Bone Hole Size Diameter | 3.7 mm | 3.0 mm | 2.0mm | 3.7 mm | 3.0 mm | 1.8 mm |
| Maximum Suture Size (Mono or Braided) | USP #2 | USP #1 | USP #0 | USP #2 | USP #1 | USP #0 |
| Delivery System | Drill Driver | Drill Driver Delivery Sleeve | Drill Driver Delivery Sleeve | Drill Driver | Drill Driver Delivery Sleeve | Drill Driver |
| Labeling | Sterile. Single Use Only. | Sterile. Single Use Only. | Sterile. Single Use Only. | Sterile. Single Use Only. | Sterile. Single Use Only. | Sterile. Single Use Only. |

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# Performance data

Extensive performance testing was conducted to ensure the material and design parameters of the TAG Bioabsorbable Anchor are adequate for their intended use and environment: performance testing is described in detail in Section 5 of this submission. Performance testing of the TAG Bioabsorbable Anchors demonstrated the following:

- Pull-out strength of the TAG Bioabsorbable Anchors is equivalent to that of the commercially available TAG Anchors when directly compared in cadaveric bones of the tibia, a worst case model.

- Pull-out strength of the TAG Bioabsorbable Anchors is greater than or equivalent to the "worst-case" clinical loads encountered by the anchors in the specified surgical indications.

- Bridge strength of the TAG Bioabsorbable Anchors is significantly greater than the largest size sutures intended for use with the anchors.

- Pull-out strength of the smallest size sutures intended for use with the TAG Bioabsorbable Anchors is greater than or equivalent to the "worst-case" clinical loads encountered by the anchors in the specified surgical indications.

- The "worst-case" clinical loads encountered by the anchors in the specified indications are lower than those encountered in the treatment of shoulder instability, one of the currently cleared indications for use (K946346).

Given the equivalent pull-out strength of the TAG Bioabsorbable Suture Anchors and TAG (non-absorbable) Suture Anchors, the performance testing conducted on the TAG Suture Anchors supports the following conclusions:

- Pull-out strength of the TAG Bioabsorbable Anchors is equivalent to that of the commercially available Mitek Mini-GII Anchors and TAG Anchors. The Mitek Mini-GII Anchors and the TAG Anchors were directly compared in cadaveric bones of the tibia (worst case), foot, ankle, and elbow.

- Repair strengths using the TAG Bioabsorbable Anchors in the foot and ankle are equivalent to standard suture repair techniques for the same soft tissue repairs.

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# Conclusion

By virtue of their equivalence in design, indications for use, and device performance, the TAG Bioabsorbable Suture Anchors are substantially equivalent to the TAG Suture Anchors and the Mitek Mini-GII Anchors.