AVCORE SYSTEM

K990816 · Modular Cutting Systems, Inc. · HWE · Sep 24, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K990816
• Device Name: AVCORE SYSTEM
• Applicant: Modular Cutting Systems, Inc.
• Product Code: HWE · General, Plastic Surgery
• Decision Date: Sep 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4820
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The AV Core System is a system of cannulated trephines and drills used to obtain and insert a contoured bone graft into a matched hole in the femoral head. The use of the system is indicated for patients suffering from Avascular necrosis of the femoral head, in which the head does not show collapse or degenerative changes.

Device Story

AvCore System consists of stainless steel cannulated trephines and matched drill bits; used by orthopedic surgeons to treat avascular necrosis of the femoral head. Procedure involves drilling a hole in the femoral head and harvesting a bone graft from the base of the trochanter using the trephines; the trephine shaft functions as an ejector for the graft material. Device is non-sterile, intended for steam sterilization. System facilitates bone grafting without requiring a secondary graft site. Clinical benefit is the mechanical removal of necrotic tissue and replacement with autologous bone graft to preserve femoral head structure.

Clinical Evidence

No clinical data provided. The device relies on established orthopedic literature (Ponseti 1949; Bonfiglio and Bardenstein 1970) regarding the use of trephines for biopsy and treatment of avascular necrosis of the femoral head to support the safety and efficacy of the surgical technique.

Technological Characteristics

Hard stainless steel cannulated trephines and drill bits; rotary operation via drill chuck; manual/powered; steam autoclave sterilization; ejector mechanism integrated into trephine shaft.

Indications for Use

Indicated for patients suffering from avascular necrosis of the femoral head, provided the femoral head has not undergone collapse or degenerative changes.

Regulatory Classification

Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

Predicate Devices

• Gambale & Merrill trephines
• Cloward System
• Codman Anterior Cervical Fusion Kit
• St. George-Buchholz knee instrumentation
• CORB Biopsy System (Zimmer Inc.)

Reference Devices

• Arthrex Inc. trephines
• Smith & Nephew trephines
• Roberts Medical, Inc. trephines

Submission Summary (Full Text)

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SEP 2 4 1999

## Modular Cutting Systems

650 Clinton Avenue Bridgeport, CT 06605

Phone [phone] Fax Fax Fax [phone]

K 990816

ALLEN P. SCHLEIN M.D.

February 28, 1999

510 (K) Summary

AvCore System

The AvCore System comprises of a series of trephines and purchased canulated drill bits of matched size, used to obtain a appropriate sized and contoured bone graft in the treatment of avascular necrosis of the femoral head.. The device is classified under the nomenclature of drills, burs, Trephines & accessories ( compound, powered). The product code is 84HBF and regulation number 882:4305 and is a Class II device.

Trephines of various types were originally utilized for performing burr holes into the skull since the days of the cave man. Modern trephines of stainless steel are still utilized in orthopedic and neurosurgery for obtaining cylindrical bone grafts and for removal of broken hardware. All of these devices including many made prior to 1976 are essentially equivalent to the cores described in this application as they are all hollow cylinders of hard stainless steel with teeth machined into their front end and shanks at the rear to be placed in a drill chuck. They are turned in a rotary fashion to obtain the circular grafts and all are sterilized by use of the steam autoclave.

In treating Avascular Necrosis of the femoral head, Ponseti reported on the use of trephines to remove the lesion for biopsy in The Journal of Bone and Joint Surgery 31-A 1949 and a similar report was written by Bonfiglio and Bardenstein in The Journal of Bone and Joint Surgery 52-A:322 1970.

The trephines used by these authors are essentially the same as those in the AvCore System. The only difference in technique is that these authors used the trephines to remove the avascular area and then used a fibular or tibial bone graft in the formed channel. In the AvCore system the bone grafts are obtained from the base of the trochanter with the trephines and the matched drills used to remove the avascular area. The shaft of the AvCoreTrephines can be unlocked and be moved forward to act as an ejector for the graft material.

Substantial equivalance is claimed to the trephines manufactured by Gambale & Merrill in the performance of cranial flaps. The trephines in the Cloward System for obtaining bone grafts for cervical fusion and the Codman Anterior Cervical Fusion Kit are also similar to those used in the

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AvCore System. A trephine was also part of the instrumentation utilized to insert the stem of the St. George- Buchholz knee. The above devices, I believe were marketed in the U.S.A. prior to 1976.

Trephines have been manufactured by DePuy Corporation, Warsaw, Indiana as screw removal instruments. The CORB Biopsy System manufactured by Zimmer Inc., Warsaw Indiana utilized powered trephines used for removal of avascular segments of the femoral head.

Trephines are presently marketed by Arthrex Inc., Naples Florida and Smith & Nephew. Andover, Massachusetts for obtaining and implantation of articular osteochondral grafts of the knee. Trephines are also used for the harvesting of knee ligament grafts and in obtaining grafts for wrist fusion by Roberts Medical, Inc. Boyertown, Pennsylvania.

Catalogue pages or advertisements are supplied for the items we feel are of substantial equivilance.

The Surgical Technique for the instruments supplied as the AvCore System is also supplied in a separate section of this 510 (K) application.

Please note that all Avcore instruments are manufactured by a contract manufacturer, FDT Precision, Taunton, Massachusetts utilizing acceptable manufacturing principles and techniques. No instrument is supplied as sterile and all instruments can be steam sterilized.

No claims are to be made for the efficacy of the technique of core biopsy which has been discussed substantially in the orthopedic literature. The instruments in the AvCore system merely facilitate the manner in which the procedure is performed, as a secondary bone graft site is not required.

Based on the documentation that trephine instrumentation both existed and was used in the treatment of avascular necrosis of the hip and other areas prior to 1976, it is my feeling that the instruments should be considered exempt or at least substantially equivalent to trephines being manufactured and sold at the present time.

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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the head and wings of the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 1999

Allen P. Schlein, M.D. President Modular Cutting Systems, Inc. 650 Clinton Avenue Bridgeport, Connecticut 06605

Re: K990816 Trade Name: AvCore System Regulatory Class: I Product Code: HWE Dated: July 2, 1999 Received: July 8, 1999

Dear Dr. Schlein:

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 (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 -- Allen P. Schlein, M.D.

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" (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,

Salie McWitter, Ph.D., M.P.H.

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 of

510(k) Number (if known):

Device Name: AV Core System

## Indications For Use:

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K940816 |

Prescription Use

(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

O