ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER)

K102834 · Kinamed, Incorporated · JDQ · Jan 12, 2011 · Orthopedic

Device Facts

• Record ID: K102834
• Device Name: ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER)
• Applicant: Kinamed, Incorporated
• Product Code: JDQ · Orthopedic
• Decision Date: Jan 12, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

a. Repair of long bone fractures due to trauma or reconstruction; b. Reattachment of the greater trochanter in total hip arthroplasty, surface replacement arthroplasty, or other procedures involving trochanteric osteotomy; c. Sternotomy closure; and d. Sublaminar and Intrafacet wiring of the spinal column.

Device Story

Iso-Elastic Cerclage System consists of 1mm and 2mm diameter cables used for bone fixation. Device functions as mechanical fastener to stabilize bone segments during orthopedic or thoracic procedures. Operated by surgeons in clinical/OR settings. Provides structural support for fracture repair, trochanteric reattachment, sternal closure, and spinal wiring. Benefits include secure bone approximation to facilitate healing.

Clinical Evidence

Bench testing only.

Technological Characteristics

Metallic bone fixation fasteners; 1mm and 2mm cable diameters; Class II device (21 CFR 888.3010).

Indications for Use

Indicated for patients requiring bone fixation for long bone fractures, greater trochanter reattachment during hip procedures, sternotomy closure, or spinal column wiring (sublaminar/intrafacet).

Regulatory Classification

Identification

A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Kinamed Inc. % Mr. Anthony Rose Senior Director of Quality Assurance and Regulatory Compliance 820 Flynn Road Camarillo, California 93012

JAN 1 2 20:

Re: K102834

Trade/Device Name: Iso-Elastic Cerclage System (1mm and 2mm cable diameter) Regulation Number: 21 CFR 888.3010 Regulation Name: Smooth or threaded metallic bone fixation fasteners Regulatory Class: Class II Product Code: JDQ Dated: December 21, 2010 Received: December 22, 2010

Dear Mr. Rose:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Anthony Rose

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH1's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

erely yours,

For Peter Simmons

k N. Melkerson

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

Enclosure

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## Indications for Use

JAN 1 2 :2011

510(k) Number (if known): K102834

Device Name: Iso-Elastic Cerclage System (1mm and 2mm cable diameter)

Indications For Use:

- a. Repair of long bone fractures due to trauma or reconstruction;
- b. Reattachment of the greater trochanter in total hip arthroplasty, surface replacement arthroplasty, or other procedures involving trochanteric osteotomy;
- c. Sternotomy closure; and
- d. Sublaminar and Intrafacet wiring of the spinal column.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE) relection Page 1 of (Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices . " 510(k) Number ﺑ