BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE

K991715 · Linvatec Corp. · MAI · Aug 6, 1999 · Orthopedic

Device Facts

• Record ID: K991715
• Device Name: BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE
• Applicant: Linvatec Corp.
• Product Code: MAI · Orthopedic
• Decision Date: Aug 6, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BioStinger™-V Bioabsorbable Meniscal Repair Device provides fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascularized area of the meniscus. Implantation of the fixation device is accomplished through arthroscopy or arthrotomy.

Device Story

BioStinger™-V is a cannulated, single-use, bioabsorbable fixation device (barbed tack with head) for meniscal repair. Made of poly(L-lactic acid) homopolymer colored with D&C Violet #2. Implanted by surgeons via arthroscopy or arthrotomy to secure longitudinal vertical meniscus lesions. Device gradually absorbs into the body over time. Provides mechanical fixation to facilitate healing of meniscal tears in vascularized zones.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Poly(L-lactic acid) with D&C Violet #2 color additive. Design: Cannulated barbed tack with head. Dimensions: 1.3mm diameter, 10mm-16mm length. Sterilization: Ethylene Oxide (EtO). Shelf life: 16 months. Single-use.

Indications for Use

Indicated for fixation of longitudinal vertical (bucket-handle) meniscus lesions in the vascularized area of the meniscus. For use via arthroscopy or arthrotomy.

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 Meniscal Repair Device (K981692)

Submission Summary (Full Text)

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# AJG - 6 -

May 19, 1999

### 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 BioStinger™-V Bioabsorbable Meniscal Repair Device.

#### Submitter A.

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773

#### Company Contact B.

Laura Seneff Manager, Requlatory Affairs

#### Device Name C.

| Trade Name: | BioStinger™-V Bioabsorbable<br>Meniscal Repair Device |
|------------------------------------|-------------------------------------------------------|
| Common Name: | Meniscal Repair Device |
| Classification Name/<br>Reference: | None Assigned |
| Proposed Class/ | Class II-87 MAL. Fastener. |

Proposed Class Device Product Code: Fixation, Biodegradable, Soft Tissue

- Predicate/Legally Marketed Devices D. Linvatec Meniscal Repair Device
### E. Device Description

.

The BioStinger™-V Bioabsorbable Meniscal Repair Device is a cannulated, sterile, single-use fixation device made of an absorbable homopolymer derived from poly(Llactic acid), similar to that used in bioabsorbable suture and will gradually be absorbed into the body. The device is colored with D&C Violet #2.

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Summary of Safety and Effectiveness BioStinger™-V Bioabsorbable Meniscal Repair Device 510 (k) # May 19, 1999 Page 2 of 3

### F. Intended Use

The BioStinger™-V Bioabsorbable Meniscal Repair Device provides fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascularized area of the meniscus.

Implantation of the fixation device is accomplished through arthroscopy or arthrotomy.

#### Substantial Equivalence G.

The colored BioStinger™-V Bioabsorbable Meniscal Repair Device is substantially equivalent in design, function and intended use to the Linvatec BioStinger™ Bioabsorbable Meniscal Repair Device.

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

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Summary of Safety and Effectiveness BioStinger™-V Bioabsorbable Meniscal Repair Device 510 (k) # Page 3 of 3

## CHART OF SIMILARITIES AND DISSIMILARITIES

・・・・・

| Company<br>Name | Device Name | Intended Use | Material | Single-Use<br>Reusable | Method of<br>Sterilization | Design |
|----------------------------------------------------------|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------|-------------------------------|---------------------------------------------------------------------------------------------|
| New Product<br>Linvatec | BioStinger™-V<br>Bioabsorbable<br>Meniscal Repair<br>Device | Fixation of longitudinal<br>vertical meniscus lesions<br>(bucket handle) located in<br>the vascularized area of the<br>meniscus. | Poly (L-lactic acid)<br>with color additive<br>D&C Violet #2 | Sterile<br>Single-use | EtO<br>16-month shelf<br>life | Cannulated<br>Barbed tack<br>with head<br>Sizes:<br>1.3mm diameter<br>x 10mm-16mm<br>length |
| Predicate<br>Linvatec<br>Corporation<br>510 (k) #K981692 | Linvatec<br>Meniscal Repair<br>Device | Fixation of longitudinal<br>vertical meniscus lesions<br>(bucket handle) located in<br>the vascularized area of the<br>meniscus. | Poly (L-lactic acid) | Sterile<br>Single-use | EtO<br>16-month shelf<br>life | Cannulated<br>Barbed tack<br>with head<br>Sizes:<br>1.3mm diameter<br>x 10mm-16mm<br>length |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG -6 1999

Ms. Laura Seneff Manager. Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

Re: K991715

Biostinger-V Bioabsorable Meniscal Repair Device Regulatory Class: II Product Code: MAI, HTY Dated: May 19, 1999 Received: May 20, 1999

Dear Ms. Seneff:

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 control provisions of the Act. The general control 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820) and that, through periodic (QS) 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.

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.

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Page 2 – Ms. Laura Seneff

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 at [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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#### May 19, 1999 Date:

#### 1 of ਹ Page

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

BioStinger™-V Bioabsorbable Meniscal Repair Device Name: Device

Indications for Use:

The BioStinger™-V Bioabsorbable Meniscal Repair Device provides fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascularized area of the meniscus.

Implantation of the device is accomplished through arthroscopy or arthrotomy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_

OR

Over-the-Counter Use*_*_

(Per 21 CFR 801.109)

Asevedo

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K99/715

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