BIODUCT

K053492 · Bioduct, LLC · MAI · Apr 12, 2007 · Orthopedic

Device Facts

• Record ID: K053492
• Device Name: BIODUCT
• Applicant: Bioduct, LLC
• Product Code: MAI · Orthopedic
• Decision Date: Apr 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BioDuct's Meniscal Fixation Device is intended for fixation of longitudinal vertical meniscus (bucket handle) lesions located in the vascularized (red-white) zone of the meniscus when used with suture.

Device Story

Arthroscopically implanted, cannulated, bioabsorbable (PLA) device; used in conjunction with suture (e.g., 5-0 Ethilon) for meniscal repair. Device placed between synovium and lesion in red-white zone of meniscus. Used by orthopedic surgeons in clinical/surgical settings. Mechanical testing demonstrates improved 3-month fixation strength compared to trephination and suture alone. Benefits patient by providing stable fixation for meniscal healing.

Clinical Evidence

Bench testing and canine model study. Mechanical testing showed improved 3-month fixation strength compared to trephination and suture alone.

Technological Characteristics

Cannulated, bioabsorbable PLA material. Sizes 5-14 mm. Arthroscopic implantation. Mechanical fixation device used with suture.

Indications for Use

Indicated for fixation of longitudinal vertical (bucket handle) meniscus lesions in the vascularized (red-white) zone. For prescription use only.

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

• DePuy Mitek RapidLoc™ Meniscal Repair System (K002406)
• Linvatec BioStinger™ Meniscal Fixation System (K991715)
• Innovasive Devices Meniscal Screw (K980681)
• Bionx Biofix® Meniscus Arrow (K955768)
• Ethicon Ethibond Excel Suture (K003070)
• Arthrex Meniscal Dart System (K983577)

Submission Summary (Full Text)

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K053492 (pg 1 of 1)

### 510(k) Summary

| Trade Name: | Meniscal Fixation Device |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Sponsor: | BioDuct, LLC<br>3201 Stellhorn Road<br>Fort Wayne, Indiana, 46815. |
| | APR 12 2007 |
| 510(k) Contact: | Herb Schwartz, Ph.D.<br>Telephone: [phone]<br>FAX: [phone] |
| Common Name: | Biodegradable soft tissue fixation device |
| Classification: | 21 CFR 888.3030 - Single/multiple component metallic bone<br>fixation appliances and accessories, Class II |
| Product Code: | 87 MAI |
| Predicate Devices: | K002406 - DePuy Mitek RapidLoc™ Meniscal Repair System<br>K991715 - Linvatec BioStinger™ Meniscal Fixation System<br>K980681 - Innovasive Devices Meniscal Screw<br>K955768 - Bionx Biofix® Meniscus Arrow<br>K003070 - Ethicon Ethibond Excel Suture<br>K983577 - Arthrex Meniscal Dart System |

## Indications for use:

BioDuct's Meniscal Fixation Device is intended for fixation of longitudinal vertical meniscus (bucket handle) lesions located in the vascularized (red-white) zone of the meniscus when used with suture.

# Device Description:

BioDuct's Meniscal Fixation Device is an arthroscopically implanted, cannulated, bioabsorbable (PLA) device used with suture, and is available in sizes ranging from 5 to 14 mm long. The Meniscal Fixation Device is designed to be placed between the synovium and a lesion located in less well vascularized (red-white) areas of the meniscus. Mechanical testing results indicate that the Meniscal Fixation Device, when used with suture (i.e. 5-0 Ethilon), improves the 3 month fixation strength of the lesion compared to trephination and suture (i.e. 5-0 Ethilon) alone as shown in the canine model.

#### Substantial Equivalence:

Based on similarities in indications, design and materials and the results of comparative testing, BioDuct's Meniscal Fixation Device is substantially equivalent to other biodegradable soft tissue fixation devices, including the predicates listed above,

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BioDuct, LLC c/o Herb Schwartz, Ph.D. President 3201 Stellhorn Road Fort Wayne, Indiana 46815

APR 1 2 2007

Re: K053492

Trade/Device Name: BioDuct's Meniscal Fixation Device Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: February 20, 2007 Received: February 22, 2007

Dear Dr. Schwartz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Herb Schwartz, Ph.D.

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Bachner

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K053492

Device Name: BioDuct's Meniscal Fixation Device

Indications for Use:

BioDuct's Meniscal Fixation Device is intended for fixation of longitudinal vertical meniscus (bucket handle) lesions located in the vascularized (red-white) zone of the meniscus when used with suture.

#### Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Barbara Buchup

(Division Sign-Division of General, Restorative, and Neurological Devices

510(k) Number K053492