SYNTHES (USA) CLAVICLE HOOK PLATES

K061753 · Synthes (Usa) · HRS · Aug 4, 2006 · Orthopedic

Device Facts

• Record ID: K061753
• Device Name: SYNTHES (USA) CLAVICLE HOOK PLATES
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Aug 4, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

Device Story

Synthes (USA) Clavicle Hook Plate is an anatomically designed L-shaped metallic bone fixation plate. Device features a distal joint-bridging hook with a rounded end to stabilize the clavicle. Shaft includes dynamic compression screw holes or LCP (locking compression plate) holes. Plate accepts 3.5 mm cortex, 4.0 mm cancellous, and 3.5 mm locking screws. Used by orthopedic surgeons in clinical/surgical settings to provide internal fixation for lateral clavicle fractures and acromioclavicular joint dislocations. Device provides mechanical stabilization to facilitate bone healing.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological characteristics.

Technological Characteristics

Metallic bone fixation plate; L-shaped design with distal hook; accepts 3.5 mm cortex, 4.0 mm cancellous, and 3.5 mm locking screws; dynamic compression or LCP hole configurations.

Indications for Use

Indicated for patients requiring surgical fixation of lateral clavicle fractures or acromioclavicular joint dislocations.

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) Clavicle Hook Plate (K061753)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold black letters, with a registered trademark symbol to the left of the word. To the right of the word "SYNTHES" is the text "KO61753 (pg 1 of )" in a handwritten font. There is a horizontal line below the word "SYNTHES".

.

.

K061753 (pg 1 of

AUG - 4 2006

| 3.0 | 510(k) Summary | Page | 1 | of | 1 |
|-----|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|----|---|
| | Sponsor: | Synthes (USA)<br>1301 Goshen Parkway | | | |
| | | West Chester, PA 19380<br>[phone] | | | |
| | Device Name: | Synthes (USA) Clavicle Hook Plate | | | |
| | Classification: | 21 CFR 888.3030: Single/multiple component metallic bone<br>fixation appliances and accessories | | | |
| | Predicate Devices: | Synthes (USA) Clavicle Hook Plate | | | |
| | Device Description: | The Synthes (USA) Clavicle Hook Plate is an anatomically<br>designed L-shaped plate featuring a distal joint bridging hook with<br>a rounded end. The shaft of the plate contains either dynamic<br>compression screw holes or LCP plate holes. The plate accepts 3.5<br>mm cortex, 4.0 mm cancellous and 3.5 mm locking screws (LCP<br>Clavicle Hook Plate only). | | | |
| | Intended Use: | Intended for fixation of lateral clavicle fractures and dislocations of<br>the acromioclavicular joint. | | | |
| | Substantial<br>Equivalence: | Information presented supports substantial equivalence. | | | |
| | | | | | |

.

and the comments of the comments of the country of

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 4 2006

Synthes (USA) % Ms. Deborah L. Jackson, RAC Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, PA 19380

Re: K061753

Trade/Device Name: Synthes (USA) Clavicle Hook 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: June 20, 2006 Received: June 21, 2006

Dear Ms. Jackson:

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

{2}------------------------------------------------

Page 2 - Ms. Deborah L. Jackson, RAC

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. product radiation on begin marketing your device as described in your Section 510(k) I mis letter will and in your of substantial equivalence of your device to a legally prematics notification " 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 11 you active 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 other general 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,

Hulbert Lemercier

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

Enclosure

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. There is a horizontal line underneath the word "SYNTHES". The word "SYNTHES" appears to be the name of a company or product.

of Page 1

Indications for Use 2.0

| 510(k) Number (if known): | K061753 |
|---------------------------|------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes (USA) Clavicle Hook Plate |
| Indications for Use: | Intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint. |

X Prescription Use (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubert Lewis

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

510(k) Number k061753