EIS THREADED SCREW FRACTURE FIXATION

K991964 · Groupe Lepine · HWC · Dec 20, 1999 · Orthopedic

Device Facts

• Record ID: K991964
• Device Name: EIS THREADED SCREW FRACTURE FIXATION
• Applicant: Groupe Lepine
• Product Code: HWC · Orthopedic
• Decision Date: Dec 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Groupe Lepine EIS threaded compression screw system is intended to be used as a fixation screw of the first metatarsal after a corrective osteotomy, or for fixation of small bones after trauma fractures. The indications for use of the screw system are as follows: to secure the two sections of bone after an osteotomy caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or arthritis secondary to a variety of diseases or anomalies, or trauma fractures.

Device Story

EIS Threaded Compression Screw System is a metallic orthopedic implant used for bone fixation. Device provides mechanical stabilization of bone segments following corrective osteotomy or trauma fractures. Used by orthopedic surgeons in clinical/surgical settings. Implanted to secure bone sections, facilitating healing and alignment. Benefits include restoration of bone stability and support for arthritic or fractured small bones.

Clinical Evidence

Bench testing only.

Technological Characteristics

Threaded compression screw system for bone fixation. Metallic construction. Mechanical fixation principle.

Indications for Use

Indicated for fixation of the first metatarsal following corrective osteotomy or fixation of small bones following trauma fractures in patients requiring bone stabilization due to osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, or other bone anomalies.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 20 1999

Mr. Douglas W. Stuart Surgical Implants, Inc. 962 South Tamiami Trail Suite 203 Sarasota, Florida 34326

Re: K991964

> Trade Name: EIS Threaded Screws for Metatarsal Fixation Regulatory Class: II Product Code: HWC Dated: October 12, 1999 Received: October 15, 1999

Dear Mr. Stuart:

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 (OS) 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. Douglas W. Stuart

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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Neil R.P. Ogdin
James E. Dillard III

Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## EXHIBIT 5

## STATEMENT of INTENDED USE

K991964 not known 510(K) Number ________________________________________________________________________________________________________________________________________________________________ EIS Threaded Compression Screw System Device Name: __

## Statement of Intended Use

Indications For Use:

The Groupe Lepine EIS threaded compression screw system is intended to be used as a fixation screw of the first metatarsal after a corrective osteotomy, or for fixation of small bones after trauma fractures.

The indications for use of the screw system are as follows: to secure the two sections of bone after an osteotomy caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or arthritis secondary to a variety of diseases or anomalies, or trauma fractures.

| Signed: | Dh Stuart |
|---------|-----------|
|---------|-----------|

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)
NRO for

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K991964 |

| Prescription Use (Per 21 CFR 801.109) | Yes | OR | Over The Counter Use | No |
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