DISTAL RADIUS LOCKING PLATING SYSTEM

K061917 · Newclip Technics · HRS · Aug 28, 2006 · Orthopedic

Device Facts

• Record ID: K061917
• Device Name: DISTAL RADIUS LOCKING PLATING SYSTEM
• Applicant: Newclip Technics
• Product Code: HRS · Orthopedic
• Decision Date: Aug 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Distal Radius Locking Plating System is intended for the fixation of intra and extra-articular fractures as well as distal radius osteotomy.

Device Story

Distal Radius Locking Plating System consists of titanium alloy plates, locking screws, locking pegs, locking threaded pegs, and cortical screws. Used by orthopedic surgeons in clinical settings for internal fixation of radius fractures and osteotomies. Device provided non-sterile; requires steam sterilization by healthcare professionals prior to surgical implantation. Plates and screws provide mechanical stabilization of bone segments to facilitate healing. System design and materials are analogous to existing predicate plating systems.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Material: Titanium alloy (Ti-6Al-4V ELI, ASTM F 136-02a). Components: Plates, locking screws, locking pegs, locking threaded pegs, cortical screws. Surface: Color anodized or non-anodized. Sterilization: Steam sterilization (non-sterile delivery).

Indications for Use

Indicated for patients requiring fixation of intra-articular fractures, extra-articular fractures, or distal radius osteotomy.

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

• Volar Radius Plate System of HAND INNOVATIONS (K030198)
• Synthes Locking Distal Radius Plating System of SYNTHES (K012114)
• Ace Humerus and Radius Plates of ACE MEDICAL COMPANY (K955472)

Submission Summary (Full Text)

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K061917 (pg. 1 of 2)

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# SUMMARY OF SAFETY AND EFFECTIVENESS

#### A. Submitter's Name and adress

AUG 2 8 2006

NEWCLIP TECHNICS Z.A du Pâtis Rue de la fontaine grillée F-44 690 La Haye-Fouassiere France Telephone : [phone] Fax : [phone]

Summary preparation date: February 15, 2011

#### B. Official Correspondent

J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 Tele/Fax - 512-388-0199 Email - [e-mail]

#### C. Establishment registration number : 3007143290

#### D. Device name

Distal Radius Locking Plating System

# E. Device Classification Name

Plate, fixation, bone (21 CFR 888.3030) Screw, fixation, bone (21 CFR 888.3040)

### F. Proposed regulatory Class

Class II

#### G. Device Product Code

HRS HWC

#### H. Panel Code

Orthopedic

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Image /page/1/Picture/0 description: The image shows the logo for Newclip Technologies. The logo features the word "NEWCLIP" in bold, black letters. Above the word is a curved line that resembles a paperclip. Below the word "NEWCLIP" is the word "TECHNOLOGIES" in a smaller, lighter font.

K061917 (pg. 2 of 2)

# I. Device Description

The Distal Radius Locking Plating System consists of plates designed for various fracture modes of the radius. The system is used with locking screws, locking pegs, locking threaded pegs and cortical screws. Each device is manufactured from titanium alloy (Ti-6Al-V4 ELI - ASTM F 136-02a) and can be supplied color anodized or notanodized.

The Distal Radius Locking Plating System will be provided non-sterile for steam sterilization by health care professionals prior to use.

#### J. Intended use:

The Distal Radius Locking Plating System is intended for the fixation of intra and extra-articular fractures as well as distal radius osteotomy.

# K. Predicate device:

- Volar Radius Plate System of HAND INNOVATIONS (K030198) ●
- Synthes Locking Distal Radius Plating System of SYNTHES (K012114) ●
- Ace Humerus and Radius Plates of ACE MEDICAL COMPANY (K955472) ●

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Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with three human profiles incorporated into the design.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

MAR - 4 2011

NewClip Technics % The Orthomedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K061917

Trade/Device Name: Radius Locking Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: June 29, 2006 Received: July 6, 2006

Dear Mr. Webb:

This letter corrects our substantially equivalent letter of August 28, 2006. 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 (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.

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Page 2 - Mr. J.D. Webb

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.

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/ReportaProblem/default.htm 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Atiz vs. nh
for

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

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for NewClip Technology. The word "NEWCLIP" is written in large, bold, black letters. Below "NEWCLIP" is the word "TECHNOLOGY" written in smaller, gray letters. Above the word "NEWCLIP" is a black arc.

# Indications for Use

K061917

510(k) Number (if known):

Device Name: Radius Locking Plating System

Indications for Use:

The Distal Radius Locking Plating System is intended for the fixation of intra and extra-articular fractures as well as distal radius osteotomy.

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)

Page 1 of

for Mark Mellemson

(Divisio annedic.

Erie Insurance Group

510(k) Number K061917