SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP

K071476 · Synthes (Usa) · JEC · Aug 24, 2007 · Orthopedic

Device Facts

• Record ID: K071476
• Device Name: SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP
• Applicant: Synthes (Usa)
• Product Code: JEC · Orthopedic
• Decision Date: Aug 24, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes (USA) 2nd Generation Pelvic C-Clamp is intended for emergency stabilization of sacrum fractures or disruptions of the sacroiliac joint with associated circulatory instability.

Device Story

External fixation device for emergency stabilization of unstable pelvic ring injuries; comprised of inner rail, two outer rails, two upper side arms, and two lower side arms; utilizes short or long cannulated nails; stored preassembled. Used in emergency clinical settings for rapid stabilization of sacrum fractures or sacroiliac joint disruptions with circulatory instability. Operated by physicians to provide mechanical stabilization, potentially improving patient outcomes by addressing circulatory instability associated with pelvic trauma.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

External fixation instrument; metallic construction; modular design with inner/outer rails and side arms; utilizes cannulated nails for bone fixation; mechanical operation; non-sterile storage (preassembled).

Indications for Use

Indicated for emergency stabilization of sacrum fractures or sacroiliac joint disruptions in patients with associated circulatory instability.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Synthes (USA) Pelvic C-Clamp

Submission Summary (Full Text)

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Image /page/0/Picture/1 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 human figure inside of a circle. To the right of the word is a small, superscripted "R" in a circle, indicating that the word is a registered trademark. A horizontal line is located underneath the word.

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| 3.0 | 510(k) Summary | | | | Page | 1 | of 1 |
|-----|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------|------|---|------|
| | Sponsor: | Synthes (USA)<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] | | AUG 2 4 2007 | | | |
| | Contact: | Angela Silvestri<br>Synthes (USA)<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] | | | | | |
| | Device Name: | Synthes (USA) 2nd Generation Pelvic C-Clamp | | | | | |
| | Classification: | The classification of the Synthes Pelvic C-Clamp 2nd Generation, as<br>per 21 of the Code of Federal Regulations, Section 888.3040 –<br>Smooth of threaded metallic bone fixation fastener. | | | | | |
| | Predicate Device: | Synthes (USA) Pelvic C-Clamp | | | | | |
| | Device Description: | The Synthes 2nd Generation Pelvic C-Clamp is an emergency<br>stabilization instrument for unstable injuries and fractures of the<br>pelvic ring. It is an external fixation device comprised of four main<br>parts: An inner rail, two outer rails, two upper side arms, and two<br>lower side arms. It utilizes short or long cannulated nails and is<br>stored preassembled. | | | | | |
| | Intended Use: | The Synthes (USA) 2nd Generation Pelvic C-Clamp is intended for<br>emergency stabilization of sacrum fractures or disruptions of the<br>sacroiliac joint with associated circulatory instability. | | | | | |
| | Substantial<br>Equivalence: | Documentation is provided which demonstrates the Synthes (USA)<br>2nd Generation Pelvic C-Clamp to be substantially equivalent to<br>other legally marketed devices. | | | | | |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms reaching upwards, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Synthes (USA) c/o Ms. Angela Silvestri Director, Regulatory Affairs 1301 Goshen Parkway West Chester, PA 19380

AUG 2 4 2007

K071476 Trade/Device Name: 2nd Generation Pelvic C-Clamp Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JEC Dated: August 3, 2007 Received: August6, 2007

Dear Ms. Silvestri:

Re:

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. Angela Silvestri

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,

Soubana Bricello

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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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. The registered trademark symbol is to the right of the word.

Indications for Use

510(k) Number (if known):

KO71476

Device Name:

2.0

:

Synthes (USA) 2nd Generation Pelvic C-Clamp

Indications for Use:

The Synthes (USA) 2nd Generation Pelvic C-Clamp is intended for emergency stabilization of sacrum fractures or disruptions of the sacroiliac joint with associated circulatory instability.

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)

Page 1 of I

Clulare Powell
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

**510(k) Number** K071746