LEFORTE SYSTEM BONE PLATE

K023360 · Jeil Medical Corporation · KTW · Oct 25, 2002 · Orthopedic

Device Facts

• Record ID: K023360
• Device Name: LEFORTE SYSTEM BONE PLATE
• Applicant: Jeil Medical Corporation
• Product Code: KTW · Orthopedic
• Decision Date: Oct 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is used for internal fracture fixation of small bone (toe, finger etc) and reconstruction of Mandible & Maxilla. (Craniomaxillofacial Skeleton)

Device Story

Leforte System Bone Plate is a metallic implant for internal fixation of small bones and craniomaxillofacial reconstruction. Device is manufactured from unalloyed titanium; intended for surgical use by physicians to stabilize fractures or reconstruct bone structures. Implant provides mechanical support to bone segments during healing process. Clinical benefit includes restoration of skeletal integrity and stabilization of fracture sites. Potential adverse effects include infection, nonunion, implant migration, or metal sensitivity.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of material specifications and intended use to legally marketed predicate devices.

Technological Characteristics

Material: Unalloyed Titanium (ASTM F67-95 G1). Design: Bone plates for internal fixation. Standards: ISO 14630, MDD 93/42/EEC. Non-sterile device.

Indications for Use

Indicated for internal fracture fixation of small bones (toe, finger, hand, foot) and reconstruction of the mandible and maxilla (craniomaxillofacial skeleton).

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

• Osteo BOS™ System (K972323)
• Lorenz Small Fragment System (K992961)
• Syntec-Taichung Non-sterile Titanium Mimi Plate (K983988)

Submission Summary (Full Text)

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Krzysica

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EXHIBIT 2 Jeil Medical Corporation 808, ACE Techno-Tower, 3rd 197-48, Kuro 3Dong Kuro-ku, Seoul, KOREA Telephone : [phone]~9 Fax: [phone] October 2, 2002 Contact: N.K.Kim, R&D Director 510(k) Summary of Safety and Effectiveness

- 1. Identification of the Device: Proprietary-Trade Name: Leforte System Bone Plate Classification Name: Plate, Fixation, Bone, Product Code HRS Common/Usual Name: Bone Plate
- 2. Equivalent legally marketed device: Osteo BOS™ System, K972323; Lorenz Small Fragment System, K992961; and Syntec-Taichung Non-sterile Titanium Mimi Plate, K983988
- 3. Indications for Use (intended use) . The device is used for internal fracture fixation of small bone (toe, finger etc) and reconstruction of Mandible & Maxilla. (Craniomaxillofacial Skeleton)
- 4. Description of the Device: Leforte system bone plate is made of unalloyed Titanium (ASTM F67-95 G1) and is manufactured and intended for internal fixation of small bones (toc, foot, finger, hand etc.) and reconstruction of Mandible & Maxilla. (Craniomaxillofacial Skeleton). Jeil Medical Co., Ltd. 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)
- Poor bone formation, Osteoporosis, Osteolysis, 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 implant.
- . Necrosis of bone.
- . Inadequate healing. Apart from these adverse effects there are always possible complications of any

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surgical procedure such as, but not limited to, infection, nerve damage, and pain which may not be related to the implant

- 6. Safety and Effectiveness, comparisons to predicate devices:

| Device name | Osteo BOS<br>System | Lorenz small<br>fragment system | Syntec-Taichung<br>nonsterile titanium<br>mimi plate | Leforte System Bone<br>Plate |
|----------------------------------|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Classification<br>Name | Plate,<br>fixation,<br>bone<br>888.3030 | Plate, fixation,<br>bone<br>888.3030 | Plate, fixation,<br>bone<br>888.3030 | Plate, fixation, bone<br>888.3030 |
| Applicant | Osteonics<br>Corp. | Walter Lorenz<br>Surgical Inc. | Syntec-taichung<br>Medical<br>Instruments co. | Jeil Medical Corp. |
| 510(K)<br>Number | K972323 | K992961 | K983988 | (This submission) |
| Material | Unalloyed<br>Titanium<br>(ASTM<br>F67-95<br>G1) | Titanium, grade<br>not specified in<br>510(k) summary | Unalloyed<br>Titanium(ASTM<br>F67-95 G1) | Unalloyed<br>Titanium(ASTM F67-<br>95 G1) |
| Intended Use | Long and<br>small bone<br>fracture<br>fixation | Stabilization &<br>fixation of fresh<br>fracture,<br>revision<br>procedure, joint<br>fusion &<br>reconstruction<br>of small bone | To treat fracture<br>of various bones &<br>small bone | Used for internal<br>fracture fixation of<br>small bone (toe, finger<br>etc) and reconstruction<br>of Mandible & Maxilla.<br>(Craniomaxillofacial<br>Skeleton) |

- 7. Conclusion: In all respects, the Leforte System Bone Plates 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.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of three intertwined snakes and a staff.

## Public Health Service

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

T 2 5 2002

Jeil Medical Corporation c/o Kamm & Associates Daniel Kamm, P. E. P. O. Bos 7007 Decrfield, Illinois 60015

Re: K023360

Trade/Device Name: Leforte System Bone Plate Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTW Dated: October 2, 2002 Received: October 7, 2002

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. Iisting 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 (QS) 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

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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
K. Leslie H. 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

510(k) Number K033470

Device Name: LeForte System Plates (various models)

Indications for Use: The device is used for internal fracture fixation of small bone (toe, finger etc) and reconstruction of Mandible & Maxilla. (Craniomaxillofacial Skeleton).

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ___ X __ OR Over the Counter Use__________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Mail A. Mulhern

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

510(k) Number K023360