MITEK NON ABSORBABLE POLYPROPYLENE H FIX

K973009 · Mitek Products · MBI · Nov 10, 1997 · Orthopedic

Device Facts

• Record ID: K973009
• Device Name: MITEK NON ABSORBABLE POLYPROPYLENE H FIX
• Applicant: Mitek Products
• Product Code: MBI · Orthopedic
• Decision Date: Nov 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Mitek meniscal fasteners ("H" Fix) are intended for the repair of torn meniscal tissue as well as the repair of a separation of the meniscus from the synovium.

Device Story

The Mitek "H" Fix is a non-absorbable polypropylene implant designed for meniscal tissue repair. It features a cylindrical "H"-shaped configuration with 90-degree opposed legs. The device is surgically implanted into the knee meniscus using a cannulated needle applicator. Once released, the device's material properties and geometry exert a compressive holding force across the tissue tear, facilitating natural healing by maintaining tissue apposition. It is intended for use by surgeons in a clinical setting. Unlike the predicate device, which requires external suturing, the "H" Fix relies on internal spring forces generated by its placement and length to secure the tissue.

Clinical Evidence

Bench testing only. Pull tests performed on bovine meniscus showed an average failure load of 16.29 pounds for the Mitek "H" Fix, which was significantly greater than the failure force of the predicate Acufex "T" Fix.

Technological Characteristics

Material: Polypropylene. Form factor: Cylindrical "H"-shaped implant with 90-degree opposed legs. Deployment: Cannulated needle applicator. Principle: Mechanical compression via material spring forces.

Indications for Use

Indicated for patients requiring repair of torn meniscal tissue or repair of meniscal separation from the synovium.

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

• ACUFEX "T" FIX DEVICE

Submission Summary (Full Text)

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K973009

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60 GI ACIER DRIVE . WESTWOOD . M OLACIEN DHIVE - WESTVLL-FREE [phone] • FAX [phone]

NOV I O

## SUMMARY OF SAFETY AND EFFECTIVENESS MITEK POLYPROPYLENE "H"DEVICE

## CONTACT

Edward F. Kent Vice President Requlatory Affairs & Quality Assurance August 11 1997

DATE

#### NAME OF DEVICE

CLASSIFICATION NAME COMMON NAME PROPRIETARY NAME

产 MITÊK POLYPROPYLENE "H" DEVICE

## PREDICATE DEVICE

ACUFEX "T" FIX DEVICE NON ABSORBABLE SUTURE

# DESCRIPTION OF DEVICE

FUNCTION

To hold (meniscal) soft tissue in apposition during the healing tirne period.

#### DEVICE DESIGN

The "H" Fix is cylindrical in cross section and configured to have one leg of the letter "H" in a 90 degree opposed position to the other.

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#### MATERIALS USED

The Mitek non absorbable "H" Fix is made from polypropylene.

#### INTENDED USE

The device is surgically placed across (through) a tear in the meniscal tissue of the knee with a needle applicator and released. The released "H" Fix produces a holding (compressive) force across the tear causing tissue apposition, which allows the natural healing process (at the tear) to occur.

## COMPARISON TO PREDICATE DEVICE(S)

The Mitek polypropylene"H" Fix device is similar to the Acufex T-Fix device in function and material, non absorbable biocompatible polymers. The T-Fix is surgically placed through a tear in the knee meniscus, toggled and then tied with sutures over external tissues to hold the "T" in place. The "H" Fix is placed through the tear in a cannulated needle and extended into the tissue, the spring forces in the material are induced by proper placement in the tissue and by the device length.

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## DESCRIPTION OF NON CLINICAL TESTS

The Mitek polypropylene non absorbable "H" Fix pull tests from bovine meniscus provided an average failure load of 16.29 pounds. The Mitek "H" device showed a significantly greater failure force than the predicate Acufex "T" Fix device when tested in the bovine meniscus.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 1997

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

K973009 Re : Mitek Non Absorbable "H" Fix Trade Name: Requlatory Class: II Product Codes: MBI and HRX Dated: August 12, 1997 Received: August 13, 1997

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 The general controls provisions of the Act 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 Requlations, 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 Requlation {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 In addition, FDA may publish further announcements action. 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 requlations.

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#### Page 2 - Mr. Edward F. Kent

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 diaqnostic 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 [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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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Mitek meniscal fasteners ( "H" Fix) are Indications For Use:

)

intended for the repair of torn meniscal tissue as well as the repair of a separation of the meniscus from the synovium.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature of

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

Prescription Use X) (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96) --