ARTHREX BIO-TRANSFIX

K011172 · Arthrex, Inc. · MNU · Jun 19, 2001 · Orthopedic

Device Facts

• Record ID: K011172
• Device Name: ARTHREX BIO-TRANSFIX
• Applicant: Arthrex, Inc.
• Product Code: MNU · Orthopedic
• Decision Date: Jun 19, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex Bio-Transfix is intended to provide ACL graft fixation in the femur in orthopaedic procedures.

Device Story

Arthrex Bio-Transfix is a cannulated, non-metallic fixation pin; composed of poly(L-lactide); 5 mm diameter; 50 mm length. Features tapered end and three barbs for cortical fixation; includes spherical fitting for driver. Used by orthopedic surgeons in clinical settings for ACL graft fixation in the femur. Device provides mechanical stabilization of graft during healing; material is bio-compatible and well-characterized.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cannulated pin; material: poly(L-lactide); dimensions: ~5 mm diameter, 50 mm length; features: tapered end, three barbs for cortical fixation, spherical driver fitting.

Indications for Use

Indicated for ACL graft fixation in the femur during orthopedic procedures.

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.

Submission Summary (Full Text)

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KO11172
510(K) Summary

2/28/01

| Company: | Arthrex, Inc. |
|----------|---------------------------------------------------|
| Address: | 2885 South Horseshoe Drive, Naples, Florida 34104 |
| Phone: | [phone] (ext. 171) |
| Fax: | [phone] |
| Contact: | Brette Masino<br>Regulatory Affairs Specialist |

| Trade Name: | Arthrex Bio-Transfix |
|-----------------|-------------------------------------|
| Common Name: | |
| Classification: | Pin, Fixation, Smooth, Non-Metallic |

## Description:

The Arthrex Bio-Transfix, composed of poly(L-lactide), is a cannulated pin having a diameter of approximately 5 mm and an overall length of 50 mm. One end is tapered 11.684 mm to a minor diameter of 1.422 mm. The other end has three barbs for cortical fixation and a spherical fitting for its driver.

#### Intended Use:

The Arthrex Bio-Transfix is intended to provide ACL graft fixation in the femur in orthopaedic procedures.

### Substantial Equivalence:

By definition, substantial equivalence means that a device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and does not raise different questions regarding safety and effectiveness from the predicate device.

The differences between the Arthrex Bio-Transfix and the predicate device do not raise any different questions regarding safety and effectiveness. Furthermore, the material is well characterized, and has been used in predicate devices with similar indications. The device, as designed, is as safe and effective as the predicate devices.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized human profiles facing to the right. The profiles are stacked on top of each other and are connected by a wavy line.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 9 2001

Mr. Vernon C. Brown Manager, Regulatory Affairs Arthrex. Inc. 2885 South Horseshoe Drive Naples. Florida 34104

Re: K011172

Trade Name: Arthrex Bio-Transfix Regulation Number: 888.3030, 888.3040 and 888.3040 Regulatory Class: II Product Code: MNU, JDR and HTY Dated: March 19, 2001 Received: April 17, 2001

Dear Mr. Brown:

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 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). 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 requirements, 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.

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Page 2 - Mr. Vernon C. Brown

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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

RSmhleeellertwton

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

Enclosure

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| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|-------------------------|
| 510(k) Number (if known): | K011172 |
| Device Name: | Arthisex Bio-Tsans fix |

Indications For Use:

The Arthrex Bio-Transfix is intended to provide ACL graft fixation in the femur in orthopedic procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Bonakibilita,

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

510(k) Number_KOillフ2

Prescription Use h an (Per 21 CFR 801.109)

:

OR

Over-The-Counter Use_ No

(Optional Format 1-2-96)