BIOBUTTON

K990194 · Linvatec Corp. · HWC · Sep 17, 1999 · Orthopedic

Device Facts

• Record ID: K990194
• Device Name: BIOBUTTON
• Applicant: Linvatec Corp.
• Product Code: HWC · Orthopedic
• Decision Date: Sep 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BioButton™ is a cortical fixation device used for secondary fixation in conjunction with an interference screw to secure soft tissue or bone-tendon-bone grafts in ACL and PCL reconstruction.

Device Story

BioButton is a sterile, single-use, absorbable cortical fixation device; composed of Poly (L-lactic) Acid homopolymer; metabolized by body over time. Used in ACL and PCL reconstruction; functions as secondary fixation device in conjunction with interference screw to secure soft tissue or bone-tendon-bone grafts. Implant is radiotranslucent under fluoroscopy; visible via MRI and CAT scan. Device intended for surgical use by orthopedic surgeons.

Clinical Evidence

No clinical data provided; safety and effectiveness supported by bench testing.

Technological Characteristics

Absorbable homopolymer derived from Poly (L-lactic) Acid. Radiotranslucent under fluoroscopy; MRI/CAT scan compatible. Sterile, single-use, cortical fixation button.

Indications for Use

Indicated for patients undergoing ACL or PCL reconstruction requiring secondary fixation of soft tissue or bone-tendon-bone grafts.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• BioScrew® Absorbable Interference Screw (K973758)
• Hewson Ligament Guide and Button (Richards Manufacturing Company, Inc.)

Submission Summary (Full Text)

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SEP 1 7 1999

September 2, 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 BioButton™ - Recessed Ligament Button, 510(k) Number K990194.

#### A. Submitter

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

14990194

### Company Contact B.

Laura Seneff Manager, Regulatory Affairs

#### C. Device Name

| Trade Name: | BioButton™ |
|-------------------------|-------------------------------------------------------------------|
| Common Name : | Recessed Ligament Button |
| Classification Names : | Smooth or threaded<br>metallic bone fixation<br>fastener 888.3040 |
| Proposed Class/Device : | Class II-87 HWC |

### Predicate/Legally Marketed Devices D.

Product Code

BioScrew® Absorbable Interference Screw Linvatec Corporation

Hewson Ligament Guide and Button Richards Manufacturing Company, Inc.

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Summary of Safety and Effectiveness BioButton™ - Recessed Ligament Button 510(k) # K990194 September 2, 1999 Page 2 of 3

# E. Device Description

The BioButton™ is a sterile, single-use fixation device made from an absorbable homopolymer derived from Poly (L-lactic) Acid that will gradually be metabolized The implant is attached to a soft tissue or bone-tendon-bone by the body. allograft during anterior and posterior cruciate ligament autograph or The implant is radiotranslucent with regard to intraoperative reconstruction. fluoroscopy, but it can be visualized with MRI and CAT scan.

## F. Intended Use

The BioButton is a cortical fixation device used for secondary fixation in conjunction with an interference screw to secure soft tissue or bone-tendon-bone grafts in ACL and PCL reconstruction.

## G. Substantial Equivalence

The BioButton™ is substantially equivalent in function and intended use to the Hewson Ligament Button, Richards Manufacturing Co., Inc.

The BioButton is substantially equivalent in materials used to the BioScrew® Absorbable Interference Screw (Linvatec Corporation) - 510(K)# K973758.

Testing has been done to prove safety and effectiveness of the device.

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird or an abstract human figure with three horizontal lines above it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 1999

Ms. Laura D. Seneff Manager, Regulatory Affairs Linvatec Corporation 11311 Concept Blvd Largo, Florida 33773

Re: K990194

Trade Name: BioButton™ Recessed Ligament Button Regulatory Class: II Product Code: HWC Dated: June 22, 1999 Received: June 23, 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 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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.

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Page 2- Ms. Laura D. Seneff

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 tollfree 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.

Cella 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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September 2, 1999

Page 1 of 1

510(k) Number: K990194

Device Name: BioButton™ - Recessed Ligament Button

Indications for Use:

The BioButton™ is a cortical fixation device used for secondary fixation in conjunction with an interference screw to secure soft tissue or bone-tendon-bone grafts in ACL and PCL reconstruction.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR

(Per 21 CFR 801.109)

Over-the-Counter Use

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