LAPIDUS PLATE

K060476 · New Deal, S.A. · HRS · May 17, 2006 · Orthopedic

Device Facts

• Record ID: K060476
• Device Name: LAPIDUS PLATE
• Applicant: New Deal, S.A.
• Product Code: HRS · Orthopedic
• Decision Date: May 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NEWDEAL Lapidus Plates are intended to be used for bone fixation such as: - arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus, - Lisfranc arthrodesis - Mono or bi-cortical osteotomies or fractures near the 1* metatarsocuneiform joint.

Device Story

The Lapidus Plate is an osteosynthesis plate designed to bridge the 1st tarsometatarsal joint. It is implanted using a locking system consisting of fixation screws and washers. The system creates a single screw-unit fixed into the bone; screws are driven through plate holes, and washers are drilled into threaded lipped sockets at the top of each hole to block the screw heads. The device is used by orthopedic surgeons in a clinical/surgical setting to stabilize bone segments during arthrodesis or fracture repair. The output is a rigid mechanical fixation of the bone, which facilitates healing and structural stability. The device benefits patients by providing secure stabilization for foot deformities and fractures.

Clinical Evidence

Bench testing only. Evaluation of bending resistance based on mechanical calculations demonstrated that the bending behavior of the Lapidus Plates is greater than that of the predicate Synthes Modular Foot System.

Technological Characteristics

Metallic bone fixation plate. Features a locking system with threaded lipped sockets, fixation screws, and washers to block screw heads. Designed for 1st tarsometatarsal joint bridging. Mechanical fixation principle.

Indications for Use

Indicated for patients requiring bone fixation, including arthrodesis of the 1st metatarsocuneiform joint for metatarsus primus varus, Lisfranc arthrodesis, and mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint.

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

• Acumed Lower Extremity Congruent Bone Plate System (K033639)
• Synthes Modular Foot System - 2.7 mm Module (K010321)
• Synthes Modular Foot System (K001941)

Submission Summary (Full Text)

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Newdeal SAS 510(k): PreMarket Notification Lapidus Plates

MY 17 -

Image /page/0/Picture/2 description: The image contains the word "CONFIDENTIAL" in bold, uppercase letters. Above the word "CONFIDENTIAL" is the alphanumeric string "K060476" in a handwritten style. The text is black against a white background.

#### V. 510(K) SUMMARY

## Lapidus Plates

## Submitter's name and address:

Newdeal SAS 10, place d'Helvétie 69006 Lyon, France Tel: [phone] Fax: [phone]

## Contact person and telephone number

Morgane Grenier Regulatory and Clinical Affairs Director Newdeal SAS 10, place d'Helvétie 69006 Lyon, France Tel: [phone] Fax: [phone]

## Alternate Contacts

## Authorized Agent in the United States

Judith E. O'Grady, RN, MSN Sr. Vice President, Regulatory Affairs, Quality Assurance and Clinical Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536, USA Tel: [phone] Fax: [phone] E-mail: [e-mail]

## Date Summary was prepared:

February 20, 2006

## Name of the device:

| Proprietary Name: | Lapidus Plate |
|-----------------------|-------------------------------------------------------------------------------------------------|
| Common Name: | Plate, Fixation, Bone |
| Classification Name: | Single/multiple component metallic bone fixation appliances and<br>accessories (21CFR 888.3030) |
| Device Product Code: | HRS |
| Classification Panel: | Orthopedic |

## Substantial Equivalence:

The Lapidus Plate is substantially equivalent to the Acumed Lower Extremity Congruent Bone Plate System, K033639 the Synthes Modular Foot System - 2.7 mm Module, K010321 and the Synthes Modular Foot System, K001941.

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Newdeal SAS 510(k): PreMarket Notification Lapidus Plates

# CONFIDENTIAL

KOREATA

## Device Description:

The NEWDEAL® Lapidus Plate consists of an osteosynthesis plate designed to bridge the 1st tarsometatarsal joint, available in different sizes, which are implanted using NEWDEAL® locking system fixation screws and washers. The NEWDEAL® locking system includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® locking system oreates a single /screw unit fixed into the bone. The osteosynthesis screws must be driven into the bone through the holes in the plate. The system is locked by means of washers drilled into the threaded lipped socket at the top of each hole, thus blocking each screw head.

#### Intended Use:

The NEWDEAL Lapidus Plates are intended to be used for bone fixation such as:

- arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus,
- Lisfranc arthrodesis -
- Mono or bi-cortical osteotomies or fractures near the 1* metatarsocuneiform joint. -

## Testing and Test Results:

An evaluation of the bending resistance based upon mechanical calculations has demonstrated that the bending behavior of the Lapidus Plates will be greater than predicate devices (Synthes Modular Foot System).

#### Conclusion

The Newdeal Lapidus Plates are substantially equivalent to commercially marketed devices, the Acumed Lower Extremity Congruent Bone Plate System, K033639 the Synthes Modular Foot System - 2.7 mm Module, K010321 and the Synthes Modular Foot System, K001941.

The Newdeal Lapidus Plates do not raise any new issues of scientific technology, safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three figures connected by flowing lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 17 2006

Newdeal SA c/o Ms. Judith O'Grady, R.N., M.S.N. Sr. VP. Regulatory Affairs Integra Lifesciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K060476

Trade/Device Name: Lapidus Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: May 10, 2006 Received: May 11, 2006

Dear Ms. O'Grady:

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

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Page 2 - Ms. Judith O'Grady, R.N., M.S.N.

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. 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/industry/support/index.html.

Sincerely yours,

Herbert Semer ws

Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### IV. Indications for Use

510(k) Number (if known):

Device Name: Lapidus Plates

## Indications For Use:

The NEWDEAL Lapidus Plates are intended to be used for bone fixation such as:

- arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus,
- Lisfranc arthrodesis -
- mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint. ﺳ

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert Lerner no

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

**510(k) Number** K060476

I

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