OMNI-FIX, HUMERAL NAIL

K991405 · Turnkey Intergration USA, Inc. · KTW · Jun 29, 1999 · Orthopedic

Device Facts

• Record ID: K991405
• Device Name: OMNI-FIX, HUMERAL NAIL
• Applicant: Turnkey Intergration USA, Inc.
• Product Code: KTW · Orthopedic
• Decision Date: Jun 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cases of fracture of the long arm bones are not uncommon and are usually caused by Cases of the surgical re-construction of the humeral is necessary to restore the patients natural alignment of the arm. The intra-medullary nail is used as a scaffold to hold the separate fractured bone sections together, until natural healing of the fracture occurs. The separate fractured bone societic when the fracture is healed for full load bearing.

Device Story

Omni-Fix intra-medullary nail system provides fracture stabilization and fixation for humeral bones. Device acts as an internal scaffold to maintain bone alignment during natural healing process. Used by orthopedic surgeons in clinical settings. Implanted via surgical procedure to hold fractured bone segments together until load-bearing capacity is restored.

Clinical Evidence

Bench testing only. Mechanical testing performed at University of Teeside (England) Engineering Materials Test Center following ASTM F383-89 protocol. Testing utilized smallest size nails; no failures reported.

Technological Characteristics

Material: Titanium Alloy (Ti-6A1-4V) per ISO 5832 part 3 and ASTM F136-84. Form factor: Intra-medullary nail. Mechanical testing standard: ASTM F383-89.

Indications for Use

Indicated for patients with humeral fractures requiring surgical reconstruction to restore natural alignment and provide a scaffold for bone healing.

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.

Predicate Devices

• Biomet, Uniflex nail system

Submission Summary (Full Text)

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JUN 2 9 1999

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K99 1405

# 962 South Tamiami Trail, Ste. 203, Sarasota, Florida 34326 • Office [phone] • Fax [phone]

June 18, 1999

The Director, US Food & Drug Administration, Center for Devices & Radiological Health, Document Mail Center, HFZ-401, 9200 Corporate Blvd. Rockville, Maryland, 20850

Attention Dr. Mishra, Orthopedic Device Evaluation Branch.

Re: 510(K 991405) Pre-Market Application for a Line Extention to Surgical Implants Inc. Omni-Fix, Intra-Medallary Nail System.

Dear Sir.

In reply to your enquirey of June 18, 1999 I present the following statements for your review on the Omni Fix Humeral nail 510(K) application.

#### SUMMARY OF SAFETY AND EFFECTIVENESS

#### PRODUCT RATIONALE & DESCRIPTION

The Omni-Fix, intra-medallary nails were designed to be used for fracture stabilization and fixation of the femur and tibia. Nails are manufactured from Titanium Alloy (Ti-6A1-4V) wrought bar stock material as per ISO 5832 part 3 and ASTM F136-84.

#### SUBSTANTIALLY EQUIVALENT PRODUCTS

We believe that the Omni-Fix, humeral intra-medallary nail system functions in the same manner and is substantially equivalent to the Biomet, Uniflex nail system which is available for commercial distribution. The implant material, design rationale, and surgical technique are substantially the same between the two systems.

# MECHANICAL TESTING TO SHOW SAFETY

The mechanical testing of our nails were performed at the University of Teeside (England) Engineering Materials Test Center following our test Protocol. Tests were carried out on the departments testing equipment as per ASTM F383-89. Two different mechanical tests were performed using the smallest size nails. No failures were seen using the test protocol on the Omni-Fix nails.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 1999

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

Re: K991405

> Trade Name: Omni-Fix, Intra-medullary Nail Regulatory Class: II Product Code: KTW Dated: April 14, 1999 Received: April 22, 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 (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. Douglas 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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Witten, Ph.D., M.D. Ce ia M. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### EXHIBIT 7

# STATEMENT OF INDICATION

K991405 510(K) Number: Device Name: Omni-Fix nailing system

Indications For Use:

Statement of Indication

Cases of fracture of the long arm bones are not uncommon and are usually caused by Cases of the surgical re-construction of the humeral is necessary to restore the patients natural alignment of the arm. The intra-medullary nail is used as a scaffold to hold the separate fractured bone sections together, until natural healing of the fracture occurs. The separate fractured bone societic when the fracture is healed for full load bearing.

Signed: DWStuart

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | X |
|---------------------------------------|----------------------|
| | OR |
| | Over The Counter Use |

(Optional Format 1-2-96)

(Division Sign-Off)

Division of General Restorative Devices

| 510(k) Number | K991405 |
|---------------|---------|
|---------------|---------|