SYNTHES (USA) LCP MODULAR FOOT PLATES

K050110 · Synthes (Usa) · HRS · Mar 4, 2005 · Orthopedic

Device Facts

• Record ID: K050110
• Device Name: SYNTHES (USA) LCP MODULAR FOOT PLATES
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Mar 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes LCP Modular Foot Plates are intended for use in selective trauma, fractures, osteotomies, reconstructive procedures and replantations of small bones including the foot and ankle.

Device Story

Synthes LCP Modular Foot Plates are metallic bone fixation implants designed for small bone surgery. The system includes locking cuboid, navicular, and talus plates. Plates are secured to bone using 2.4 mm and 2.7 mm cortex and locking screws. Used by orthopedic surgeons in clinical settings to stabilize fractures, perform osteotomies, or facilitate reconstructive procedures and replantations. The device provides mechanical stabilization of bone segments to promote healing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation plates (locking cuboid, navicular, talus) and screws (2.4 mm and 2.7 mm cortex/locking). Employs LCP (Locking Compression Plate) technology for mechanical stabilization. Class II device under 21 CFR 888.3030.

Indications for Use

Indicated for patients requiring surgical fixation of small bone fractures, osteotomies, reconstructive procedures, or replantations in the foot and ankle.

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

• Synthes (USA) Modular Foot System

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized letter "S" inside of a circle. To the right of the word is a registered trademark symbol. A horizontal line is located underneath the word.

| 3.0 | 510(k) Summary | Page 1 of 1 |
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| | Sponsor: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone] |
| | Device Name: | Synthes (USA) LCP Modular Foot Plates |
| | Classification: | Class II, §888.3030 – Single/multiple component bone fixation<br>appliances and accessories |
| | Predicate Device: | Synthes (USA) Modular Foot System |
| | Device Description: | Synthes LCP Modular Foot Plates consist of locking cuboid,<br>navicular and talus plates used to treat small bone fractures. The<br>plates are attached to bone via 2.4 and 2.7 mm cortex and locking<br>screws. |
| | Intended Use: | The Synthes LCP Modular Foot Plates are intended for use in<br>selective trauma, fractures, osteotomies, reconstructive procedures<br>and replantations of small bones including the foot and ankle. |
| | Substantial<br>Equivalence: | Documentation is provided which demonstrates that the Synthes<br>(USA) LCP Modular Foot Plates are substantially equivalent to<br>other legally marketed devices.<br><br>The term “substantial equivalence” as used in this 510(k)<br>notification is limited to the definition of substantial equivalence<br>found in the Federal Food, Drug and Cosmetic Act, as amended<br>and as applied under 21CFR 807, Subpart E under which a device<br>can be marketed without premarket approval or reclassification. A<br>determination of substantial equivalency under this notification is<br>not intended to have any bearing whatsoever on the resolution of<br>patent infringement suits or any other patent matters. No<br>statements related to, or in support of substantial equivalence<br>herein shall be construed as an admission against interest under the<br>US Patent Laws or their application by the courts. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

MAR 4 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kathy Anderson Regulatory Affairs Manager Synthes USA 1690 Russell Road Paoli, Pennsylvania 19301

Re: K050110 Trade/Device Name: LCP Modular Foot Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/ multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: January 17, 2005 Received: January 18, 2005

Dear Ms. Anderson:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o neve revea your your 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 connect 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 your be subject to such additional controls. Existing major regulations affecting your device r may or below 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 complics 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 -- Ms. Anderson

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maneting your intial equivalence of your device to a legally prematics notification. "The PDF intently on 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 If you desire specific advise 10. 90. at 200) 276-0120 . Also, please note the regulation entitled, Contact the Office of Come to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miorinational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Mark McMillan

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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2.0

Indications for Use

510(k) Number (if known):

Synthes (USA) LCP Modular Foot Plates Device Name:

Indications for Use:

The Synthes LCP Modular Foot Plates are intended for use in selective trauma, fractures, The Symnes ECF Modular Foot Rais and replantations of small bones including the foot and ankle.

Over-The-Counter Use AND/OR X Prescription Use _ (21 CFR 807 Subpart C) (Per 21 CFR 801.109)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Gener Restorative,
and Neurological

510(k) K05 0110

CONFIDENTIAL .