NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM

K101254 · Tecnologia Y Diseno Industrial, S.A DE C.V · HWC · Jul 15, 2010 · Orthopedic

Device Facts

• Record ID: K101254
• Device Name: NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM
• Applicant: Tecnologia Y Diseno Industrial, S.A DE C.V
• Product Code: HWC · Orthopedic
• Decision Date: Jul 15, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Newfix Screw, Wire and Pin Fixation System is to be used as implants for the fixation of bone fractures, fusion of joints or bone reconstructions or as guide pins for insertion of other implants.

Device Story

Newfix Screw, Wire and Pin Fixation System is a family of orthopedic implants including Kirschner wires, Schanz screws, Steinmann pins, and conic threaded bone screws. Devices are manufactured from implant-grade stainless steel. Used by surgeons in clinical settings for bone fracture fixation, joint fusion, bone reconstruction, or as guide pins for other implants. Pins feature smooth or self-drilling/self-tapping threaded designs with diamond tips. System includes manual accessory tools: depth gauge, tissue protection triple guide, T-shape handle chuck, and drill bits. Devices are provided non-sterile and require sterilization by the user prior to implantation. Intended for single-patient use only.

Clinical Evidence

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

Technological Characteristics

Materials: Stainless Steel 316 LS/LVM. Configurations: Kirschner pins (1.6–2.5mm diameter), Schanz screws (2.5–6mm diameter), Steinmann pins (3.5–5mm diameter), and Conic pins. Features: Smooth or self-drilling/self-tapping threaded pins with diamond tips. Sterilization: Non-sterile, requires user sterilization. Accessory tools: Depth gauge, tissue protection guide, chuck, drill bits.

Indications for Use

Indicated for patients requiring bone fracture fixation, joint fusion, bone reconstruction, or guide pins for implant insertion.

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

• Treu-Instrumente GmbH Bone Fixation Screws and Pins (k083912)

Submission Summary (Full Text)

{0}------------------------------------------------

K101254 (1/3)

Tecnología y Diseño Industrial, S.A. de C.V. Newfix Screw, Wire and Pin Fixation System Summary of Safety and Effectiveness

### SUMMARY OF SAFETY AND EFFECTIVENESS

July 13, 2010

Trade Name: Newfix Screw, Wire and Pin Fixation System

Common Name: Screw, Fixation, Bone

JUL 1 5 2010

Applicant:

,

Tecnología y Diseño Industrial, S.A. de C.V. José Adán Ortega Torres Operation Manager

José Guadalupe Zuno 48 Col. Parque Industrial los Belenes Zapopan, Jalisco Mexico, C.P. 45101

Tel: [phone] Ext. 2960 [phone] Fax: [phone]

Classification Name: Smooth or threaded metallic bone fixation fastener Classification Panel: Orthopedic

All questions and/or comments concerning this document should be made to:

Robert J. Bard, Esq. Managing Director

HealthCare Technologies Consultants PO Box 506 South Lyon, MI 48178 Tel: [phone] Cell: 734-330-5990 email: [e-mail]

{1}------------------------------------------------

#### 1.0 DEVICE SUMMARY

The Tecnologia y Diseño Industrial, S.A. de C.V. Newfix® Screw. Wire and Pin Fixation System of devices are a family of external fixation pins and screws for use in orthopedic treatment fractures.

- 1.1 Classification Information
Table SE1: Device Classification

| Classification or descriptor | Name or designation |
|------------------------------|----------------------------------------------------|
| Common Name | Smooth or threaded pin |
| Device Trade Name | Newfix Screw, Wire and Pin Fixation System |
| Device Classification Name | Smooth or threaded metallic bone fixation fastener |
| Device Classification | Class II |
| Reviewing Panel | Orthopedic |
| Regulation Number | 21 CFR 880.3040 |
| Product Code | HWC |

#### 2.0 PREDICATE DEVICES

The Newfix Screw systems are substantially equivalent to the following predicate products.

- 2.1 Treu-Instrumente GmbH Bone Fixation Screws and Pins
2.1.1 510(k) Number: k083912

#### 3.0 INTENDED USE AND INDICATIONS FOR USE

The Newfix® Screw, Wire and Pin Fixation System is intended to be used as implants for the fixation of bone fractures, fusion of joints or bone reconstructions or as guide pins for insertion of other implants.

#### DEVICE DESCRIPTIONS 4.0

- 4.1 The Newfix® Screw, Wire and Pin Fixation System is a family of threaded external fixator of various sizes for use in the treatment of fractures.
- 4.2 Pins include smooth and self drilling/self-tapping type threaded pin with diamond tip and cutting edges.
- 4.3 The pin and screws of the Newfix System are manufactured using implant grade stainless steel.
- 4.4 Pin configurations include Kirschner Pins (K-wires), Schanz Screws, Steinmann Pin and Conic Threaded Bone Screws all in various lengths, diameters and threads.

| 4.4.1 | | Dimensional specifications |
|-------|--|----------------------------|
|-------|--|----------------------------|

- Table SE2: Dimensional specs

| Pin Type | Diameter (Ø) | Length |
|------------------------|----------------|--------------|
| Kirschner pin (K-wire) | Ø 1.6 – 2.5 mm | 100 – 400 mm |
| Schanz screw | Ø 2.5 - 6 mm | 60 - 250 mm |

{2}------------------------------------------------

K101254 (3/2)

Tecnología y Diseño Industrial, S.A. de C.V. Newfix Screw, Wire and Pin Fixation System Summary of Safety and Effectiveness

| Steinmann pin | Ø 3.5 – 5 mm | 150 - 250 mm |
|---------------|----------------------|--------------|
| Conic pin | Ø 4-3.0/2.5 – 6/5 mm | 60 - 220 mm |

- 4.5 The Newfix® Screw, Wire and Pin Fixation System is intended for single patient use. None of the components of the Newfix System are reusable.
- 4.6 The Newfix® Screw, Wire and Pin Fixation System includes the following accessory devices: Depth Gauge; Tissue Protection Triple Guide for Axial Fixation; T Shape Handle Chuck; and Drill Bits.

#### 5.0 COMPARISON OF DEVICE UNDER REVIEW AND ITS PREDICATES

- 5.1 Comparison of Devices

| Comparison<br>Element | TDI Newfix® Screw, Wire and Pin<br>Fixation System | TREU-INSTRUMENTE GmbH<br>Bone Fixation Screws and Pins |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Tecnologia y Diseño Industrial, S.A.<br>de C.V. | TREU-INSTRUMENTE GmbH |
| Indication for/<br>Intended Use | The Newfix® Screw, Wire and Pin<br>Fixation System is intended to be<br>used as implants for the fixation of<br>bone fractures, fusion of joints or<br>bone reconstructions or as guide<br>pins for insertion of other implants. | The Treu Bone Fixation Screws<br>and Pins are intended to be<br>used as implants for the fixation<br>of bone fractures, fusion of joints<br>or bone reconstructions or as<br>guide pins for insertion of other<br>implants. |
| Materials | Stainless Steel 316 LS/LVM Implant<br>Grade. | Titanium and stainless steel<br>(ISO 58/32-1) |
| Duration of Use | Greater than 30 days | Greater than 30 days |
| Reuse Capability | Single use | Single use |
| Fixation | Pins/Screws | Pins/Screws |
| Sterility | Non-sterile (to be sterilized prior to<br>use) | Non-sterile (to be sterilized prior<br>to use) |

{3}------------------------------------------------

Image /page/3/Picture/11 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. In the center of the seal is an abstract image of an eagle. The eagle is facing to the right and has three stripes on its wings.

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

Technología y Diseño Industrial SA DE CV % Mr. Robert J. Bard, JD P.O. Box 506 South Lyon, Michigan 48178

DEPARTMENT OF HEALTH & HUMAN SERVICES

JUL 1 5 2010

Re: K101254

Trade/Device Name: Newfix Screw, Wire and Pin Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: April 29, 2010 Received: May 4, 2010

Dear Mr. Bard:

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.

{4}------------------------------------------------

### Page 2- Mr. Robert J. Bard, JD

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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

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

4

.s.

Enclosure

{5}------------------------------------------------

## Indication for Use

JUL 1 5 2010

# 510(k): K101254

Device Name: Newfix Screw, Wire and Pin Fixation System

Indication for Use: The Newfix Screw, Wire and Pin Fixation System is to be used as implants for the fixation of bone fractures, fusion of joints or bone reconstructions or as guide pins for insertion of other implants.

Prescription Use X (21 CFR Part 801 Subpart D)

"。

AND/OR

Over the Counter Use (21 CFR Part 801 Subpart C)

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

.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jonetu for mxn
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101254