BIO-ANCHOR

K963369 · Linvatec Corp. · MAI · May 22, 1997 · Orthopedic

Device Facts

• Record ID: K963369
• Device Name: BIO-ANCHOR
• Applicant: Linvatec Corp.
• Product Code: MAI · Orthopedic
• Decision Date: May 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Linvatec Bio-Anchor is indicated for bladder neck suspension for female urinary incontinence due to urethral hypermobility.

Device Story

Bio-Anchor is a PLLA (poly-L-lactic acid) suture anchor used for soft tissue to bone fixation. Device features a cylindrical body with three circular ribs and a centrally located eyelet. Surgeon threads non-absorbable polyester suture through the eyelet; design allows for sliding knots. Once implanted, suture ends are passed through soft tissue and tied to reattach tissue to bone. Used in bladder neck suspension procedures for female urinary incontinence. Operated by surgeons in clinical settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Poly (L-lactic) acid (PLLA). Form factor: Cylindrical with three circular ribs, 2.5mm to 5.2mm diameter. Sterilization: Ethylene oxide (EtO). Mechanical fixation via suture eyelet.

Indications for Use

Indicated for bladder neck suspension in females with urinary incontinence due to urethral hypermobility.

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

• Linvatec Revo/Mini Revo (K953954)
• Mitek GII Anchor (K892126)
• Mitek Absorbable Anchor (K944051)
• Zimmer Statak Device (K926384)
• Zimmer Resorbable Soft Tissue Attachment Device (K950275)
• Vesica Medical, Inc. Bone Anchor System (K932925)

Submission Summary (Full Text)

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K963369
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MAY 22 1997

March 10, 1997

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the Bio-Anchor, 510(k) Number K963369.

## A. Submitter

Linvatec Corporation
11311 Concept Boulevard
Largo, Florida 33773-4908

## B. Company Contact

Carol A. Weideman, Ph.D.
Manager, Regulatory and Clinical Affairs

## C. Device Name

Trade Name: Bio-Anchor
Common Name: Suture Anchor
Classification Name: Soft tissue to bone fixation device

## D. Predicate/Legally Marketed Devices

Linvatec Revo/Mini Revo
Mitek GII Anchor and Absorbable Anchor
Zimmer Statak Device
Zimmer Resorbable Soft Tissue Attachment Device
Vesica Medical, Inc.

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<963369
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Summary of Safety and Effectiveness
Bio-Anchor® Absorbable Suture Anchor
510(k) # K963369
Page 2

## E. Device Description

The Bio-Anchor is a PLLA suture anchoring device. The device is cylindrical in shape with three circular ribs perpendicular to the long axis. The first and second ribs are the same size, with the proximal, third rib wider to allow for a centrally located eyelet running perpendicular to the long axis of the device. Freely passing suture is then threaded onto the Bio-Anchor by the surgeon. The lack of permanent attachment of the suture to the Bio-Anchor allows the use of sliding knots. Once the Bio-Anchor is implanted, the ends of the suture are passed through the soft tissue and tied for reattachment. Synthetic non-absorbable, polyester USP #0, #1, or #2 suture is recommended for use with this device.

The material used for this device is:

Anchor - Poly (L-lactic) acid (PLLA)

## F. Intended Use

The Linvatec Bio-Anchor is indicated for bladder neck suspension for female urinary incontinence due to urethral hypermobility.

The Bio-Anchor Absorbable Suture Anchor is available in sizes ranging from 2.5mm to 5.2mm diameter.

## G. Substantial Equivalence

The Bio-Anchor® Absorbable Suture Anchor is substantially equivalent in function and intended use to the Mitek Surgical Products GII Anchor, Zimmer’s Statak and Resorbable Soft Tissue Attachment Device, Vesica Medical’s Bone Anchor System. The material is the same (PLLA) as Zimmer’s Resorbable device.

The similarities/dissimilarities to the predicates are shown in the attached table.

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Summary of Safety and Effectiveness
Bio-Anchor® Absorbable Suture Anchor
510(k) # K963369
Page 3

# SUBSTANTIAL EQUIVALENCE INFORMATION:

## CHART OF SIMILARITIES AND DISSIMILARITIES

| Company Name | Device Name | Intended Use | Material | Single-Use Reusable | Sizes |
| --- | --- | --- | --- | --- | --- |
| New Product
Linvatec:
Bio-Anchor | Bio-Anchor | Bladder neck suspension for female urinary incontinence due to urethral hypermobility. | Poly (L-lactic) acid | Single-use ETO Sterilized Shipped sterile | 2.5mm - 5.2mm diameter |
| Products
Linvatec:
Preloaded Soft Tissue Anchors
510(k) Number
K953954 | Revo/Mini
Revo | Soft tissue to bone fixation | Titanium Alloy 6AI-4V-ELI
Suture: Non-absorbable
Braided Polyester | Single-use Gamma Sterilization Shipped sterile | Suture Anchor with Preloaded Suture Anchors: 2.5mm - 5.2mm
Suture: USP Sizes #0 to #2 |
| Products
Mitek:
Mitek GII Anchor
510(k) Number
K892126 | Mitek | Soft tissue to bone fixation - Bladder Neck Suspension | Titanium Alloy | Single-use Sterilization Method Unknown Shipped sterile | 2.4mm X 14mm |

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| Company Name | Device Name | Intended Use | Material | Single-Use Reusable | Sizes |
| --- | --- | --- | --- | --- | --- |
| Products
Mitek:
Mitek Absorbable Anchor
510(k) Number
K944051 | Mitek | Soft tissue to bone fixation - Bladder Neck Suspension | Poly (L-lactic) acid and Nitinol | Single-use Sterilization Method
Unknown
Shipped sterile | Not provided |
| Products
Zimmer:
Statak Device
510(k) Number
K926384 | Statak | Soft tissue to bone fixation - Bladder Neck Suspension | Tivanium TI-6Al-4V Alloy
# 2 Braided Suture | Single-use Gamma Sterilization
Shipped sterile | 2.5mm - 5.2mm diameter |
| Products
Zimmer Resorbable Soft Tissue Attachment Device
510(k) Number
K950275 | Resorbable Soft Tissue Attachment Device | Soft tissue to bone fixation | Poly (L-Lactic) Acid
# 2 Braided Suture | Single-use Gamma Sterilization
Shipped sterile | 5.0mm - 5.2mm diameter |
| Products
Vesica Medical, Inc.:
Bone Anchor System
510(k) Number
K932925 | Bone Anchor System | Soft tissue to bone attachment for urological application - bladder neck suspension | Titanium alloy
#1, #2 Suture Size | Single-use EtO Sterilization
Shipped sterile | 3.75mm diameter |

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAY 22 1997

Carol A. Weideman, Ph.D.
Manager
Regulatory and Clinical Affairs
Linvatec Corporation
11311 Concept Boulevard
Largo, Florida 34643

Re: K963369
Trade Name: BioAnchor™ Absorbable Suture Anchor
Regulatory Class: II
Product Code: MAI
Dated: March 10, 1997
Received: March 11, 1997

Dear Dr. Weideman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Carol A. Weideman, Ph.D.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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Linvatec

11311 Concept Boulevard Largo. Florida 33773-1908 813 392-6464

May 16, 1997

510(k) Number (if known): K963369

Device Name: BIO-ANCHOR™ ABSORBABLE SUTURE ANCHOR

Indications for Use:

**Bladder Neck Suspension**

The Linvatec Bio-Anchor is indicated for bladder neck suspension for female urinary incontinence due to urethral hypermobility.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)

Division of General Restorative Devices

510(k) Number K963369

Prescription Use ☑ OR Over-the-Counter Use ☐

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

A Bristol-Myers Squibb Company

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