FOOT AND HAND MOTION SYSTEM

K091118 · Newclip Technics · HWC · Dec 16, 2009 · Orthopedic

Device Facts

• Record ID: K091118
• Device Name: FOOT AND HAND MOTION SYSTEM
• Applicant: Newclip Technics
• Product Code: HWC · Orthopedic
• Decision Date: Dec 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The implants of the Foot and Hand Motion System are indicated for the fixation of bone fractures and for bone reconstruction in the hand and forefoot surgery.

Device Story

The Foot and Hand Motion System consists of metallic bone fixation fasteners (screws, plates, or similar hardware) used by orthopedic surgeons in clinical settings. These implants provide mechanical stabilization for bone fractures or reconstruction sites in the hand and forefoot. The device functions by physically securing bone segments to facilitate healing and restore structural integrity. It is a passive mechanical implant system; no software, sensors, or electronic components are involved. The system is intended for surgical implantation to benefit patients by stabilizing skeletal injuries or correcting deformities.

Clinical Evidence

Bench testing only.

Technological Characteristics

Metallic bone fixation fasteners; smooth or threaded design; intended for orthopedic surgical use; class II device (21 CFR 888.3040).

Indications for Use

Indicated for fixation of bone fractures and bone reconstruction in hand and forefoot surgery for adult and pediatric patients requiring orthopedic stabilization.

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Newclip Technics % The OrthoMedix Group, Inc. % Mr. J.D. Webb 1001 Oakwood Blvd. Round Rock, TX 78681

DEC 1 6 2009

Re: K091118

Trade/Device Name: Newclip Foot and Hand Motion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, JDR Dated: November 18, 2009 Received: November 24, 2009

Dear Mr. Webb:

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 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 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. J.D. Webb

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ 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/cdrh/mdr/ for the CDRH'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/cdrh/industry/support/index.html.

Sincerely yours,

Jucta 75

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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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## 3. INDICATIONS FOR USE

## 510(k) Number (if known): KO9 \ \ \ \ {

Device Name: Foot and Hand Motion System

Indications for Use:

The implants of the Foot and Hand Motion System are indicated for the fixation of bone fractures and for bone reconstruction in the hand and forefoot surgery.

Prescription Use AND/OR Part 21 CFR 801 Subpart D)

Over-The-Counter Use ____________

(21 CFR 801 Subpart C)

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Smuta for nxn
(Division Sign)

(Division Sign Off) Division of Surgical, Ofthopedic, and Restorative Devices

510(k) Number K091118

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