BIOFASTIN RC THREADED SUTURE ANCHOR

K021883 · Mitek Worldwide · HWC · Jul 1, 2002 · Orthopedic

Device Facts

• Record ID: K021883
• Device Name: BIOFASTIN RC THREADED SUTURE ANCHOR
• Applicant: Mitek Worldwide
• Product Code: HWC · Orthopedic
• Decision Date: Jul 1, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BIOFASTIN RC Threaded Suture Anchor is indicated for shoulder rotator cuff repair.

Device Story

BIOFASTIN RC Threaded Suture Anchor is an absorbable, threaded device used for shoulder rotator cuff repair. It features an auger-type design with two threads, a 5.0 mm nominal diameter, and an 11.5 mm nominal length. The anchor head contains two suture holes spaced 90 degrees apart for attaching #2 sutures (ETHIBOND non-absorbable or PANACRYL absorbable) to bone. Sutures are provided pre-attached with tapered needles. The device is used by surgeons in an operating room setting to secure soft tissue to bone, facilitating healing and repair of the rotator cuff.

Clinical Evidence

Bench testing only.

Technological Characteristics

Absorbable, threaded suture anchor; auger-type design; 5.0 mm diameter; 11.5 mm length; two suture holes; pre-attached #2 sutures (ETHIBOND or PANACRYL).

Indications for Use

Indicated for shoulder rotator cuff repair in patients requiring surgical fixation of soft tissue to bone.

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

• FASTIN RC Suture Anchor
• Mitek CuffTack Sutureless Fixation Device
• PANALOK RC Absorbable Anchor

Submission Summary (Full Text)

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ப்பட 1 2002 510(k) Summary

| Trade Name: | BioFastin RC Threaded Suture Anchor |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Mitek Worldwide<br>249 Vanderbilt Avenue<br>Norwood, MA 02062<br>Registration #1221934 |
| Contact: | Ruth Forstadt, Senior Regulatory Affairs Associate |
| Device Generic Name: | Fastener, Fixation, Biodegradable Soft Tissue |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class II. |
| Product Code: | 87 MAI |
| Predicate Device(s): | FASTIN RC Suture Anchor<br>Mitek CuffTack Sutureless Fixation Device<br>PANALOK RC Absorbable Anchor |
| Product Description: | The BIOFASTIN RC Threaded Suture Anchor is an<br>absorbable, threaded suture anchor. The BIOFASTIN RC<br>anchor has 2 threads of an auger-type design with an<br>overall nominal diameter of 5.0 mm and nominal length of<br>11.5 mm. The device has two suture holes (90 degrees<br>apart) in the anchor head for fixation of #2 suture to bone<br>(sutures provided pre-attached with affixed tapered<br>needles). The sutures provided with the BIOFASTIN RC<br>are either the ETHIBOND non-absorbable or PANACRYL<br>absorbable sutures. |
| Indications for Use: | The BIOFASTIN RC Threaded Suture Anchor is indicated<br>for shoulder rotator cuff repair. |
| Safety and Performance: | Results of performance testing have demonstrated that the<br>modified device is substantially equivalent to the predicate<br>devices. |

くい

## Conclusion:

Based on 1) safety and performance data, and 2) similarities in design, operating principles, biocompatibility and sterilization method, the BIOFASTN RC Threaded Suture Anchor has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

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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 features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a symbol that resembles an abstract human form or a bird-like shape, composed of three curved lines or strokes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## 1 2002 . IUL

Ms. Ruth C. Forstadt Senior Regulatory Affairs Associate Mitek Worldwide 249 Vanderbilt Avenue Norwood, Massachusetts 02062

Re: K021883

Trade/Device Name: BIOFASTIN RC Threaded Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Codes: HWC, MAI, GAM, GAS Dated: June 6, 2002 Received: June 7, 2002

Dear Ms. Forstadt:

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 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.

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Page 2 – Ms. Ruth C. Forstadt

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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Neil RP Ozden

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

Enclosure

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Page 1 of 1

510(k) Number (if known): K021803

Device Name: BIOFASTIN RC Threaded Suture Anchor

## Indications for Use:

The BIOFASTIN RC Threaded Suture Anchor is indicated for shoulder rotator cuff repair.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

NRa for cmw

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

2021883 510(k) Number -

Prescription Use న (Per 21 CFR 801.109)

OR

Over-the -Counter Use

Confidential

2002-06-06 0007

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