SELF-COMPRESSIVE SCREW

K131471 · Neosteo · HWC · Aug 28, 2013 · Orthopedic

Device Facts

• Record ID: K131471
• Device Name: SELF-COMPRESSIVE SCREW
• Applicant: Neosteo
• Product Code: HWC · Orthopedic
• Decision Date: Aug 28, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Self-Compressive Screws are intended for the fixation of bone fractures and for bone reconstruction in forefoot surgery.

Device Story

Self-Compressive Screws are metallic bone fixation fasteners used in forefoot surgery. Implants consist of titanium alloy screws available in various diameters and lengths. Fixation is achieved via screw threading, which provides compression across the fracture or reconstruction site. The device is intended for use by orthopedic surgeons in a clinical or surgical setting. It functions as a mechanical implant to stabilize bone segments, facilitating healing through compression.

Clinical Evidence

No clinical studies were performed. Evidence is based on bench testing, specifically resistance to torsion and pull-out strength per ASTM F543 standards.

Technological Characteristics

Titanium alloy (ASTM F136). Threaded metallic bone fixation fastener. Mechanical compression via threading. Dimensions vary by diameter and length. Bench testing performed per ASTM F543 (Annex 1: Torsion; Annex 3: Pull-out).

Indications for Use

Indicated for fixation of bone fractures and bone reconstruction in forefoot surgery.

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

• Newclip Foot and Hand Motion System (K091118)

Submission Summary (Full Text)

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K131471

Image /page/0/Picture/2 description: The image shows the logo for Neosteo. The logo consists of a circular design on the left and the word "neosteo" on the right. Below the word "neosteo" is the phrase "EFFICIENT MOBILITY" in smaller letters. The circular design is made up of a series of dots and lines.

## 510(k) Summary

Preparation Date: May 2013

Version 1

#### l. SUBMITTER'S INFORMATION

## A. 510(k) Owner

NEOSTED

2 Rue Robert Schuman 44 400 REZE, France Tel: [phone] Fax: [phone]

#### B. Contact Person

JD Webb The Orthomedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 Tel: [phone]

Fax: [phone]

Email: [e-mail]

C. Date of Preparation of the 510(k) Summary 20″ May 2013

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Image /page/1/Picture/1 description: The image shows the logo for Neosteo Efficient Mobility. The logo consists of a circular design on the left and the word "neosteo" on the right. Below the word "neosteo" is the phrase "EFFICIENT MOBILITY". The circular design is made up of a series of dots and lines.

## 510(k) Summary

Preparation Date: May 2013

Version 1

#### II. DEVICE IDENTIFICATION

#### A. Trade or proprietary name

Self-Compressive Screw

#### B. Common or usual name

Self-compressive screw range

#### C. Classification name

Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040, Product code HWC)

D. Class

ll

ﻨﻨ Product code

HWC

F. CFR section

21 CFR 888.3040

#### G. Device panel

Orthopedic

## H. Predicate devices

The Self-Compressive Screw is similar to the following predicate device which has been cleared via the premarket notification process: Newclip Foot and Hand Motion System (K091118).

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#### Version 1

Image /page/2/Picture/2 description: The image shows the logo for Neosteo. The logo consists of a spiral design on the left and the word "neosteo" on the right. Below the word "neosteo" is the phrase "EFFICIENT MOBILITY" in smaller letters.

## 510(k) Summary

Preparation Date: May 2013

#### DEVICE DESCRIPTION lll.

The Self-Compressive Screw consists of screws available in several diameters and lengths.

All the implants are made of titanium alloy.

The fixation is provided thanks to the threading of the screw, which allows compression.

#### A. Materials

Titanium alloy per ASTM F136

#### IV. INTENDED USE

The Self-Compressive Screws are intended for the fixation of bone fractures and for bone reconstruction in forefoot surgery.

#### SUBSTANTIAL ー V. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS EQUIVALENCE

The Self-Compressive Screw is substantially equivalent to the predicate device in terms of intended use, design, materials used, mechanical safety and performances.

#### VI. NON-CLINICAL TEST SUMMARY

The following mechanical tests were performed:

- Resistance to torsion according to ASTM F543 -- Annex 1
- Pull-out strength according to ASTM F543 Annex 3. .

The results of these testing indicate that the current Self-Compressive Screw is equivalent to predicate device.

#### VII. CLINICAL TEST SUMMARY

No clinical studies were performed.

-

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#### Version 1

## 510(k) Summary

Preparation Date: May 2013

#### CONCLUSIONS NON-CLINICAL AND CLINICAL VIII.

NEOSTEO considers the current Self-Compressive Screw to be equivalent to the predicate device listed above. This conclusion is based on the devices' similarities in principles of operation, technology, materials and indications for use.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

August 28, 2013

Neosteo Efficient Mobility % The Orthomedix Group, Incorporated Mr. JD Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K131471

Trade/Device Name: Self-Compressive Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: May 27, 2013 Received: May 30, 2013

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 I ou may, alereleve, mains 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. JD Webb

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,

# Erin I. Keith

For

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

Enclosure

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Page 1 of 1

K131471

Image /page/6/Picture/2 description: The image shows the logo for Neosteo Efficient Mobility. The logo consists of a circular design on the left and the company name on the right. The circular design has a central circle with lines radiating outwards, while the company name is written in a bold, sans-serif font, with the words "EFFICIENT MOBILITY" written in smaller letters below.

## Indication For Use Statement

Version 1

Preparation Date: April 2013

510(k) Number (if known): K131471

Device Name: Self-Compressive Screws___

Indications for Use:

The Self-Compressive Screws are intended for the fixation of bone fractures and for bone reconstruction in forefoot surgery.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

## Elizabeth L. Frank -S

Division of Orthopedic Devices