HUMERUS LOCKING PLATING SYSTEM

K063095 · Newclip Technics · HRS · Dec 22, 2006 · Orthopedic

Device Facts

• Record ID: K063095
• Device Name: HUMERUS LOCKING PLATING SYSTEM
• Applicant: Newclip Technics
• Product Code: HRS · Orthopedic
• Decision Date: Dec 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Humerus Locking Plating System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.

Device Story

Humerus Locking Plating System consists of bone plates and various screws (locking, cortical, pegs) for fixation of proximal humerus fractures, dislocations, osteotomies, and non-unions. Device is provided non-sterile for steam sterilization by healthcare professionals. Used in clinical settings by orthopedic surgeons to stabilize bone segments; facilitates healing through rigid fixation. System components are manufactured from titanium alloy or stainless steel. Output is physical stabilization of bone fragments.

Clinical Evidence

bench testing only

Technological Characteristics

Materials: Titanium alloy Ti-6A1-V4 ELI (ASTM F 136-02a/ISO 5832-3) or stainless steel (ASTM F 138/ISO 5832-1). Components: Plates, locking screws, smooth/threaded locking pegs, cortical screws. Features: Cannulated or non-cannulated options, color anodized or non-anodized finish. Sterilization: Steam sterilization required by user.

Indications for Use

Indicated for patients with fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.

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

• Modified Shoulder Fixation System of HAND INNOVATIONS (K051728)
• SYNTHES LCP® Proximal Humerus Plates, long of SYNTHES (K041860)
• Proximal Humerus Plate of ACUMED (K012655)
• Stryker Plating System of HOWMEDICA OSTEONICS CORP. (K060798)

Submission Summary (Full Text)

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K063095

Image /page/0/Picture/1 description: The image shows the word "NEWCLIP" in bold, sans-serif font. Above the word is a curved line that resembles a paperclip. The word is likely the name of a company or product.

DEC 2 2 2006

## 4. 510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS

### A. Submitter's Name and adress

NEWCLIP TECHNICS Z.A du Pâtis Rue de la fontaine grillée F-44 690 La Haye-Fouassiere France Tele : (33) 2 28 21 37 12 Fax : [phone]

Summary preparation date: October 6, 2006

### B. Official Contact Person

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

# C. Establishment registration number : Applied for

### D. Device name

Humerus 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

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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, sans-serif font. Below the word "NEWCLIP" is the word "Technologies" in a smaller, sans-serif font. Above the word "NEWCLIP" is a curved line that resembles a check mark.

H. Panel Code

Orthopedic

#### I. Device Description

The Humerus Locking Plating System consists of plates designed for various fracture modes of the humerus bone. The system is used with locking screws, smooth locking pegs, threaded locking peg, locking cortical screws and standard cortical screws. The locking screws, threaded pegs and pegs could be supplied cannulated or not. Each device is manufactured from titanium alloy Ti-6A1-V4 ELI (conforms to ASTM F 136-02a and/or ISO 5832-3) or stainless steel (conforms to ASTM F 138 and/or ISO 5832-1). Each device can be supplied color anodized or non-anodized.

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

### J. Intended use:

The Humerus Locking Plating System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.

### K. Predicate device:

- . Modified Shoulder Fixation System of HAND INNOVATIONS (K051728)
- SYNTHES LCP® Proximal Humerus Plates, long of SYNTHES (K041860) .
- Proximal Humerus Plate of ACUMED (K012655) .
- Stryker Plating System of HOWMEDICA OSTEONICS CORP. (K060798) .

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that suggest the shape of a bird in flight. The text is in a simple, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Newclip Technics % Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

DEC 2 2 2006

Re: K063095 Trade/Device Name: Humerus 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: September 29, 2006 Received: October 13, 2006

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 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. J.D. Webb

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,

Barbara buelum
to

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/4/Picture/0 description: The image shows the logo for NEWCLIP. The logo is in black and white and features the word "NEWCLIP" in bold, sans-serif letters. Above the word "CLIP" is a curved line that resembles a paperclip. Below the word "NEWCLIP" are some smaller, less distinct letters.

3. INDICATIONS FOR USE

510(k) Number (if known):

K663095

Device Name: Humerus Locking Plating System

Indications for Use:

The Humerus Locking Plating System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.

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 ____________________________________________________________________________________________________________________________________________________________________

Barbara Buchin

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

510(k) Number K03095