LEFORTE SYSTEM BONE SCREW

K023365 · Jeil Medical Corporation · HWC · Apr 18, 2003 · Orthopedic

Device Facts

• Record ID: K023365
• Device Name: LEFORTE SYSTEM BONE SCREW
• Applicant: Jeil Medical Corporation
• Product Code: HWC · Orthopedic
• Decision Date: Apr 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Leforte System Screws are intended for fracture fixation as well as reconstruction and stabilization of small bones (i.e. toe, foot, finger, hand, etc) and the mandibulofacial (i.e. mandible and maxilla) bones.

Device Story

Leforte System Bone Screws are metallic orthopedic implants used for fracture fixation, reconstruction, and stabilization of small bones and mandibulofacial structures. The system includes common, self-drilling, and dual-head screws available in micro, mid, mini, and maxi classes. Manufactured from titanium alloy (ASTM F136-98), these devices are provided non-sterile and require steam sterilization by the user prior to surgical implantation. The screws are intended for use by surgeons in clinical settings to provide mechanical fixation of bone segments. By securing bone fragments, the device facilitates healing and stabilization of fractures or reconstructive sites. The device is designed to be functionally equivalent to existing titanium alloy bone screw systems.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing, material composition (ASTM F136-98), and comparison of design characteristics to legally marketed predicate devices.

Technological Characteristics

Material: Titanium alloy (ASTM F136-98). Types: Common, self-drilling, and dual-head screws. Classes: Micro, mid, mini, and maxi. Sterilization: Non-sterile, requires steam sterilization. Design: Metallic bone fixation fastener.

Indications for Use

Indicated for fracture fixation, reconstruction, and stabilization of small bones (toe, foot, finger, hand) and mandibulofacial bones (mandible, maxilla).

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

• Twist off™ Screw (K971069)
• Aesculap Titanium Alloy Bone Screws (K970549)
• K3 Bone Screw System (K960533)

Submission Summary (Full Text)

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## KC23365 Page V3

## EXHIBIT 2. 510(K) SUMMARY

APR 1 8 2003

Jeil Medical Corporation 808, ACE Techno-Tower, 3rd 197-48, Kuro 3Dong Kuro-ku, Seoul, KOREA Telephone : [phone]~9 Fax: [phone] January 30, 2002 Contact: N.K.Kim, R&D Director 510(k) Summary

- 1. Identification of the Device: Proprietary-Trade Name: Leforte System Bone Screw Classification Name: Screw, Fixation, Bone, Product Code HWC Common/Usual Name: Bone Screw
- 2. Equivalent legally marketed device: Twist off™ Screw Medinov-AMP, K971069, Aesculap Titanium Alloy Bone Screws Aesculp, Inc., K970549, K3 Bone Screw System, Kinetikos Medical Inc., K960533
- 3. Indications for Use (intended use) . The Leforte System Screws are intended for fracture fixation as well as reconstruction and stabilization of small bones (i.e. toe, foot, finger, hand, etc) and the mandibulofacial (i.e. mandible and maxilla) bones
- 4. Description of the Device: Leforte system bone screw is made of Titanium alloy (ASTM F136) and consists of common bone screw, self-drilling screw (auto screw) and dual head screw. The common bone screws are classified to 4 classes; Micro screw, Mid screw, Mini screw, Maxi screw. This device is manufactured and intended for small bone (toe, foot, finger, hand etc.) and mandibulofacial (mandible & Maxilla) fracture fixation. Also This device is intended for reconstruction & stabilization of small bone and mandibulofacial (mandible & Maxilla) Jeil Medical Corporation utilizes the state of the art technology and apply the essential requirement of MDD (93/42/EEC) and ISO 14630, 1997 from the device design to manufacturing and QC ...
- 5. Potential Adverse Affects and Complications: (Common to all devices of this type)

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- Poor bone formation, Osteoporosis, Osteomyelitis, inhibited revascularization, . or infection can cause loosening, bending, cracking or fracture of the device or premature loss of fixation with the bone, leading to nonunion.
- Nonunion or delayed union which may lead to breakage of the implant. ●
- Migration, bending, fracture or loosening of the implant. .
- . Metal sensitivity, or allergic reaction to a foreign body:
- Decrease in bone density due to stress shielding. .
- Pain, discomfort, or abnormal sensation due to the presence of the device. .
- Increased fibrous tissue response around the fracture site and/or the implan". ●
- Necrosis of bone. ●
- Inadequate healing.

Apart from these adverse effects there are always possible complications of any surgical procedure such as, but not limited to, infection, nerve damage, and pain which may not be related to the implant

| Device Name | Twist off™<br>Screw | Aesculap<br>Titanium<br>Alloy Bone<br>Screws | K3 Bone Screw<br>System | Le forte System<br>(Bone Screw) |
|----------------------------------|----------------------------------------------------------|----------------------------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Device<br>Classification<br>Name | No Comment | Screw, Fixation,<br>Bone<br>888.3030 | Smooth or Threaded<br>Bone Fixation<br>Fastener | Screw, Fixation, Bone<br>888.3040 |
| Applicant | Medinov-AMP | Aesculp, Inc. | KMI<br>(Kinetikos Medical<br>Inc.) | Jeil Medical<br>Corporation |
| 510(K) Number | K971069 | K970549 | K960533 | (This submission) |
| Material | Titanium Alloy | Titanium Alloy | Titanium Alloy<br>(Ti-6Al-4V ELI<br>Alloy<br>: ASTM F136-84) | Titanium Alloy<br>(ASTM F 136-98) |
| Intended use | Fixation of<br>fracture, fusion<br>of a joint or<br>Bone | Long & small<br>bone fracture<br>fixation | Fixation/stabilization<br>of small bones in<br>hand or small bones<br>in mid & forefoot | Small bone and<br>mandibulofacial<br>(mandible & Maxilla)<br>fracture fixation |

- 6. Comparisons to predicate devices:

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| | reconstruction of<br>the carpals,<br>metacarpals &<br>phalanges of the<br>hand | | fractures | reconstruction &<br>stabilization of small<br>bone and<br>mandibulofacial<br>(mandible & Maxilla) |
|-------------------|--------------------------------------------------------------------------------|------------|------------|---------------------------------------------------------------------------------------------------|
| Supplied Sterile? | No Comment | No Comment | No comment | Non sterile, steam<br>sterilize before use |

- 7. Conclusion: In all respects, the Leforte System Bone Screws are the equivalent of currently marked devices. They are made of the same materials and have similar dimensions and characteristics. Potential adverse effects are identical to those of predicate devices. This device is manufactured from material of titanium alloy (ASTM 136-97) that is used generally in this kind of bone screw. Similar devices made from titanium alloy (ASTM 136-97) to this device are manufactured and sold around the world. This device, Le forte system bone screw is substantially equivalent in design, material, intended use and function to the products on the table above. These devices are certificated by notified body for CE.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20:350

APR 1 8 2003

Jeil Medical Corporation c/o Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K023365

Trade Name: LeForte System Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 3, 2003 Received: February 4, 2003

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Mr. Daniel Kamm, P.E.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sincerely yours,

Mark N Millman

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

Enclosure

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j) Indications for Use

K023365 510(k) Number_

Device Name: LeForte System Screws (various models)

"The Leforte System Screws are intended for fracture fixation as well as reconstruction and stabilization of small bones (i.e. toe, foot, finger, hand, etc) and the mandibulofacial (i.e. mandible and maxilla) bones."

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use × OR (Per 21 CFR 801.109)

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

Mark N Mlkern
for Division Sign Off

(Division Sign-Off) Division of General, Restorative and Neurological Devices

10(k) Number K023365