MITEK BTB ABSORBABLE (PLA) CROSS PIN

K974291 · Mitek Products · HTY · Mar 5, 1998 · Orthopedic

Device Facts

• Record ID: K974291
• Device Name: MITEK BTB ABSORBABLE (PLA) CROSS PIN
• Applicant: Mitek Products
• Product Code: HTY · Orthopedic
• Decision Date: Mar 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To hold a bone tendon bone graft in place by cross pinning in the femoral tunnel during a period of time following surgery allowing the natural healing process(es) to occur.

Device Story

The Mitek BTB Absorbable (PLA) Cross Pin is a fixation device used in ACL reconstruction surgery. It is designed to secure bone-tendon-bone (BTB) grafts within the femoral tunnel. The device consists of a 1.654-inch long pin with a 0.105-inch diameter and a conical tip. During surgery, two pins are inserted across the bone plug into the adjacent femur to hold the graft in position during the healing period. The device is intended for use by surgeons in a clinical/OR setting. It provides mechanical stability to the graft, facilitating the natural healing process. The device is made of absorbable PLA material.

Clinical Evidence

No clinical tests were done for this product. Bench testing included bending and shear tests, as well as pull-out strength comparisons against the predicate device. Eight-week in-vitro tests were also conducted, showing results comparable to zero-day results.

Technological Characteristics

Material: Purac (PLA). Dimensions: 1.654" length, 0.105" diameter, 0.180" conical tip. Fixation principle: Mechanical cross-pinning. Sterilization: Not specified.

Indications for Use

Indicated for femoral fixation of autograft or allograft ACL 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

• Linvatec PLA Bioscrew (K960940)

Submission Summary (Full Text)

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**ETHICON**...
a fohnson fohnson company

PHONE [phone] • TOLL-FREE [phone] • FAX [phone]

MAR - 5 1998

K974291

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### SUBMITTER

NAME ADDRESS TEL# CONTACT DATE

Mitek Surgical Products, Inc. 60 Glacier Drive, Westwood, MA 02090 781-251-2700 Robert Zoletti, Manager, Regulatory Affairs November 14, 1997

NAME OF DEVICE CLASSIFICATION NAME COMMON NAME COMMON

Staple, Fixation, Bone, & soft tissue A device for holding tissue in apposition Mitek BTB Absorbable(PLA)Cross Pin

PROPRIETARY NAME

510(k) SUMMARY FOR K9XXXXX

PREDICATE DEVICE

Linvatec PLA Bioscrew

DESCRIPTION OF DEVICE

FUNCTION

To hold bone graft in position during healing period DEVICE DESIGN

The Cross Pin is 1.654″ long by 0.105″ dia with a conical tip by .180 long.

MATERIALS USED

The Cross Pin is molded from Purac(PLA)

INTENDED USE

ﺮﻳﺰﻳﻨ

To hold a bone tendon bone graft in place by cross pinning in the femoral tunnel during a period of time following surgery allowing the natural healing process(es) to occur.

# COMPARISON TO PREDICATE DEVICE

The Cross Pin compares to the predicate device, Linvatec Bioscrew, (K)960940, in that it is made from the same type of material (PLA), and is used to hold the bone graft in place in the femoral tunnel during rehabilitation and healing process. The the preparation for the ACL reconstruction surgery is similar for each device,i.e., tibial and femoral bone tunneling and graft placement into the tunnel. The fixation process of the Bioscrew wedges the bone plug in place while the Cross Pin secures the bone plug by pinning(2 pins)across the plug into the adjacent femur.

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#### DESCRIPTION OF NON CLINICAL TESTS

Bench top Bending and Shear tests were done on the PLA pins and strength comparisons to the Bioscrew in pull out tests were done to the Bioscrew. The results showed that there was no'significant strength difference between the two. Eight week In-vitro tests were also done and found to have results that were comparable to "zero" day results.

DESCRIPTION OF CLINICAL TESTS No clinical tests were done for this product

#### CONCLUSIONS FROM TESTS

The bench test performance, molding materials, and intended use show that the two devices perform equally.

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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 image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 5 1998

Mr. Edward F. Kent Vice President Regulatory Affairs Mitek® Products 60 Glacier Drive Westwood, Massachusetts 02090

Re: K974291

> Trade Name: BTB Absorbable (PLA) Cross Pin Regulatory Class: II Product Codes: HTY and MAI Dated: February 25, 1998 Received: February 27, 1998

Dear Mr. Kent:

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.

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 - Mr. Edward F. Kent

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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510(k) Number (if known):_

Device Name: - MITEK 2.7mm BTB CROSS'PIN

Indications For Use:

Femoral fixation of autograft or allograft ACL Bone Tendon Bone Grafts

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K974291

Prescription Use (Per 21 CFR 801.109)

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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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