SELF- COMPRESSIVE SCREW

K153182 · Neosteo · HWC · Nov 25, 2015 · Orthopedic

Device Facts

• Record ID: K153182
• Device Name: SELF- COMPRESSIVE SCREW
• Applicant: Neosteo
• Product Code: HWC · Orthopedic
• Decision Date: Nov 25, 2015
• 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 the hand and in the forefoot surgery.

Device Story

Self-Compressive Screw is a metallic bone fixation fastener used in orthopedic surgery. Device consists of titanium alloy screws available in various diameters and lengths. Principle of operation relies on screw threading to provide bone compression and fixation. Used by surgeons in clinical settings for hand and forefoot bone reconstruction or fracture fixation. Output is the mechanical stabilization of bone segments. Benefits include structural support for healing fractures and reconstructed bone.

Clinical Evidence

No clinical data. Bench testing only: resistance to torsion (ASTM F543 Annex 1) and pull-out strength (ASTM F543 Annex 3) performed to confirm equivalence.

Technological Characteristics

Titanium alloy (ASTM F136). Threaded metallic bone fixation fastener. Dimensions vary by diameter and length. Mechanical fixation via threading.

Indications for Use

Indicated for fixation of bone fractures and bone reconstruction in the hand and 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

• Self-Compressive Screw (K131471)
• Newclip Foot and Hand Motion System (K091118)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three heads, depicted in a simple, black and white design.

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

November 25, 2015

Neosteo % JD Webb Official Correspondent The Orthomedix Group, Inc 1001 Oakwood Blvd Round Rock. Texas 78681

Re: K153182

Trade/Device Name: Self- Compressive Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: October 30, 2015 Received: November 3, 2015

Dear JD 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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

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

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

K153182

Device Name

Self Compressive Screw

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

X | Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the logo for Neosteo Efficient Mobility. The logo consists of an orange spiral design on the left, followed by the word "neosteo" in orange, and the words "EFFICIENT MOBILITY" in smaller orange font below it. The spiral design is made up of a series of orange lines and dots.

Version 1 Preparation Date: May 2013

#### 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

30th October 2015

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Image /page/4/Picture/0 description: The image shows the logo for Neosteo. The logo consists of an orange spiral design on the left and the word "neosteo" in orange on the right. Below the word "neosteo" is the phrase "EFFICIENT MOBILITY" in a smaller, lighter orange font.

Version 1 Preparation Date: May 2013

#### 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

E. Product code

HWC

#### CFR section F.

21 CFR 888.3040

### G. Device panel

Orthopedic

### H. Primary predicate device

The Self-Compressive Screw is similar to the following predicate device which has been cleared via the premarket notification process: Self-Compressive Screw (K131471).

#### l. Secondary predicate device

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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Image /page/5/Picture/0 description: The image contains the logo for "neosteo EFFICIENT MOBILITY". To the left of the text is an orange graphic that resembles a spiral made of lines and dots. The text is also orange and is in a sans-serif font. The word "neosteo" is in a larger font than the words "EFFICIENT MOBILITY".

Version 1 Preparation Date: May 2013

#### III. DEVICE DESCRIPTION

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 the hand and in the forefoot surgery.

#### CHARACTERISTICS V. OF SUBSTANTIAL SUMMARY TECHNOLOGICAL 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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Image /page/6/Picture/0 description: The image contains the logo for Neosteo. The logo consists of an orange spiral design on the left, followed by the word "neosteo" in orange, and the words "EFFICIENT MOBILITY" in smaller orange font below the word "neosteo". The spiral design is made up of a series of orange lines and dots.

Version 1 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.