LISFRANC PLATE

K060474 · New Deal, S.A. · HRS · Aug 3, 2006 · Orthopedic

Device Facts

• Record ID: K060474
• Device Name: LISFRANC PLATE
• Applicant: New Deal, S.A.
• Product Code: HRS · Orthopedic
• Decision Date: Aug 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NEWDEAL Lisfranc Plates are intended to be used for fractures, fusions, osteotomies and replantations of small bones of the tarsometatarsal joints (Lisfranc joints).

Device Story

Osteosynthesis plate system designed for stabilization of tarsometatarsal (Lisfranc) joints; used for fractures, fusions, osteotomies, and replantations. System comprises metallic plates, fixation screws, and washers. Locking mechanism utilizes threaded lipped sockets on plate; washers are driven into sockets to block screw heads, securing construct. Implanted by orthopedic surgeons in clinical/surgical settings. Provides rigid fixation to facilitate bone healing/fusion; benefits patient by stabilizing small bone segments during recovery.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Metallic bone fixation plate system. Features threaded lipped sockets for screw locking via washers. Dimensions vary by size. Intended for small bone fixation.

Indications for Use

Indicated for fractures, fusions, osteotomies, and replantations of small bones at the tarsometatarsal (Lisfranc) joints.

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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# 510(K) SUMMARY

## K060474

#### Lisfranc Plates

AUG - 3 2006

#### 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:

July 17, 2006

#### Name of the device:

| Proprietary Name: | Lisfranc 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 Lisfranc 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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#### Device Description:

Device Description:
The NEWDEAL® Lisfranc Plate consists of an osteosynthesis plate designed to bridge the The NEWDEAL "Listranc joints). It is available in different sizes, and is implanted using tarsometatisal Journs (Listiane Johns). It is a rand washers. The NEWDEAL® locking system NCWDEAL "focking system manon ove are threaded lipped sockets on the plate and as many includes as mally fixation serews as there are the care a single implant/screw wasners as implanted scrows. The NETH Dis 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 Lisfranc Plates are intended to be used for fractures, fusions, osteotomies The NEW DEALL Boxmall bones of the tarsometatarsal joints (Lisfranc joints).

## Testing and Test Results:

Performance testing was conducted compared to a legally marketed predicate device. The I cronnames results was in a between the Lisfranc Plates and the predicate device.

#### Conclusion

sion The Newton Lower Extremity Congruent Bone Plate System, K033639 the devices, the Acaned 20ws. Black 2010321 and the Synthes Modular Foot System, K001941.

The Newdeal Lisfranc 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 seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 3 2006

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

K060474 Re:

Trade/Device Name: Lisfranc Plate Regulation Number: 21 CFR 888.3030 Regulation Namber. 21 OF No 0015 000
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: July 17, 2006 Received: July 18, 2006

Dear Ms. O'Grady:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications ferenced above und have active development to legally marketed predicate devices marketed in interstate for use stated in the encrosale) to regard mannent date of the Medical Device Amendments, or to comments provision of they 20, 1978, are eccordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). alle Cosment Act (Act) that do not required to the general controls provisions of the Act. The r ou may, mererore, manot the Act include requirements for annual registration, listing of general controls provisions of the rece 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 If your device is classified (600 world). Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FDA an may be subject to suen adatterial resultsions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Couv acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issualled of a buice complies with other requirements of the Act that IDA has made a decerminations administered by other Federal agencies. You must

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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 Levenson

V 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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# Indications for Use

510(k) Number (if known): K060474

Device Name: Lisfranc Plates

Indications For Use:

The NEWDEAL Lisfranc Plates are intended for fractures, fusions, osteotomies and replantations of small bones at the tarsometatarsal joints (Lisfranc joints)

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 Vern Page 1 of 1

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

**510(k) Number** K060474