SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM

K073186 · Synthes (Usa) · HRS · Dec 17, 2007 · Orthopedic

Device Facts

• Record ID: K073186
• Device Name: SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Dec 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes 3.5mm LCP Clavicle Plate System is intended for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle.

Device Story

System consists of machined metallic plates and screws for internal bone fixation. Plates are pre-contoured to fit clavicle anatomy; include options with lateral extensions for distal clavicle fractures and standard plates for shaft fractures. Designed to provide screw-to-plate locking, minimize soft tissue irritation, and reduce vascular trauma. Used by surgeons in clinical/OR settings to stabilize bone segments; facilitates healing by maintaining alignment during osteosynthesis. Benefits include enhanced stability and anatomical fit.

Clinical Evidence

Bench testing only.

Technological Characteristics

Metallic bone fixation plates and screws. Features screw-to-plate locking mechanism. Pre-contoured design for clavicle anatomy. Materials and specific ASTM standards not disclosed in provided text.

Indications for Use

Indicated for patients requiring surgical fixation of clavicle fractures, malunions, non-unions, and osteotomies.

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 3.5mm Dynamic Compression Locking (DCL) Plates (as cleared in Synthes Small Fragment DCL System)

Submission Summary (Full Text)

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K073186

| 3.0 | 510(k) Summary | Page 1 of 1 |
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| Sponsor: | Synthes (USA)<br>Karl J. Nittinger<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone]<br>DEC 17 2007 | |
| Device Name: | Synthes 3.5mm LCP Clavicle Plate System | |
| Classification: | Class II. §888.3030 - Single/multiple component metallic bone fixation appliances and accessories | |
| Predicate Device: | Synthes 3.5mm Dynamic Compression Locking (DCL) Plates as cleared in Synthes Small Fragment DCL System | |
| Device Description: | Synthes 3.5mm LCP Clavicle Plate System consists of machined metallic plates and screws that offer screw to plate locking designed for various fracture modes of the clavicle.<br><br>Synthes 3.5mm LCP Clavicle Plate System enhances fracture fixation by providing pre-contoured plates designed to fit the clavicle and design features which allow additional contouring. minimization of soft tissue irritation, and minimization of vascular trauma. The Synthes 3.5mm LCP Clavicle System includes plates with a lateral extension feature specifically designed to enhance the stability of the fixation of fractures in the distal clavicle and plates without the lateral extension feature for fixation of fractures in the clavicle shaft. | |
| Intended Use: | Synthes 3.5mm LCP Clavicle Plate System is intended for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle. | |
| Substantial Equivalence: | Information presented supports substantial equivalence. | |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 7 2007 % Mr. Karl J. Nittinger Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, PA 19380 Re: K073186 Trade/Device Name: SYNTHES 3.5mm LCP Clavicle Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: Nov 12, 2007 Received: Nov 13, 2007

Dear Mr. Nittinger:

SYNTHES (USA)

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 (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. Karl J. Nittinger

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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,

Mark N. Mulkerson

Mark N. Melkerson 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

510(k) Number (if known): Device Name: Synthes 3.5mm LCP Clavicle Plate System Indications for Use: Synthes 3.5mm LCP Clavicle Plate System is intended for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle.

Indications for Use

Prescription Use _ X (Per 21 CFR 801 109)

AND/OR

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

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Bucher

Division of General, Restorative, and Neurological Devices

510(k) Number K073186