Alians Fragment Specific

K170843 · Newclip Technics · HRS · Jun 16, 2017 · Orthopedic

Device Facts

• Record ID: K170843
• Device Name: Alians Fragment Specific
• Applicant: Newclip Technics
• Product Code: HRS · Orthopedic
• Decision Date: Jun 16, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Alians Fragment Specific range is intended for hand and forearm fractures, osteotomies and arthrodeses in adults.

Device Story

Alians Fragment Specific range consists of metallic bone plates and screws; used for internal fixation of hand and forearm fractures, osteotomies, and arthrodeses. Implants provide mechanical stabilization of bone segments to facilitate healing. Devices are implanted by orthopedic surgeons in clinical or surgical settings. Implants provided either non-sterile for facility-based sterilization or pre-sterilized via gamma radiation. System includes associated surgical instruments for implantation. Output is physical stabilization of bone; clinical decision-making relies on surgeon assessment of fracture patterns and anatomical requirements.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by non-clinical bench testing including comparative static and fatigue bend tests (ASTM F382), and torsional, insertion/removal, and pull-out tests (ASTM F543).

Technological Characteristics

Materials: Titanium alloy Ti-6Al-4V (ASTM F136, ISO 5832-3) and CP-titanium (ASTM F67, ISO 5832-2). System comprises metallic bone plates and screws for fixation. Sterilization: Gamma radiation or facility-based steam sterilization. No software or electronic components.

Indications for Use

Indicated for adults requiring fixation for hand and forearm fractures, osteotomies, and arthrodeses.

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

• APTUS® Wrist 2.5 System of Medartis (K142906)
• Trimed Bone Plates of Trimed (K060041)
• 2.4mm VA-LCP Dorsal Distal Radius Plates of Synthes (K102694)
• Universal Distal Radius System of Newclip Technics (K130774)
• Footmotion Plating System of Newclip (K161448)
• Activ Ankle Locking Plating System of Newclip (K143061)

Submission Summary (Full Text)

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Public Health Service

Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line.

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

June 16, 2017

Newclip Technics % Mr. J.D. Webb Official Correspondent The OrthoMedix Group, Incorporated 1001 Oakwood Blvd Round Rock, Texas 78681

Re: K170843

Trade/Device Name: Alians Fragment Specific 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: March 17, 2017 Received: March 21, 2017

Dear Mr. J.D. 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

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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 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 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,

# Vincent J. Devlin -S

for

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)

K170843

Device Name Alians Fragment Specific

Indications for Use (Describe)

The Alians Fragment Specific range is intended for hand and forearm fractures, osteotomies and arthrodeses in adults.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows the logo for Newclip Technics. The logo consists of a circle with the letters "nct" inside. The "t" has an upward-pointing arrow as part of the letter. Below the circle is the text "NEWCLIP-TECHNICS" in a sans-serif font.

#### 510 (k) Summary for the ALIANS FRAGMENT SPECIFIC 4. range

In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the Alians Fragment Specific range.

Summary preparation date: January 10, 2017

#### 1. Submitter:

#### Contact Person:

J.D. Webb NEWCLIP TECHNICS P.A. de la Lande Saint Martin The OrthoMedix Group, Inc. 45 rue des Garottières 1001 Oakwood Blvd Round Rock, TX 78681 F-44115 Haute-Goulaine - France Telephone: [phone] Telephone: [phone]

- Alians Fragment Specific 2. Trade name: Fracture fixation plates and screws Common Name: Product code: HRS - Plate, Fixation, Bone HWC - Screw, Fixation, Bone Classification Name: Single/multiple component metallic bone fixation appliances and accessories. (21 CFR part. 888.3030) Smooth or threaded metallic bone fixation fastener.(21 CFR part. 888.3040)

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Image /page/4/Picture/1 description: The image shows the logo for Newclip-Technics. The logo consists of a circle with the letters "nct" inside. The "t" has an upward-pointing arrow as part of the letter and is colored in red. Below the circle, the words "NEWCLIP - TECHNICS" are written in a sans-serif font.

#### 3. Primary predicate or legally marketed devices which are substantially equivalent:

- . APTUS® Wrist 2.5 System of Medartis (K142906)
#### Secondary predicate or legally marketed devices which are substantially equivalent:

- Trimed Bone Plates of Trimed (K060041) .
- 2.4mm VA-LCP Dorsal Distal Radius Plates of Synthes (K102694), .
- Universal Distal Radius System of Newclip Technics (K130774). •
- Footmotion Plating System of Newclip (K161448) .
- Activ Ankle Locking Plating System of Newclip (K143061) .

| 4. Description of the device: | The Alians Fragment Specific range<br>consists of plates and screws designed for<br>hand and forearm fractures, osteotomies<br>and arthrodeses in adults. |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The implants of the Alians Fragment<br>Specific range will be provided non sterile<br>for sterilization by health care professionals<br>prior to use or provided sterile by gamma<br>sterilization.<br>The instruments of the Alians Fragment<br>Specific range will be provided non sterile<br>for sterilization by health care professionals<br>prior to use.<br>Single use kits (Initial FS) contain implants<br>and instruments provided sterile by gamma<br>sterilization. |
| Materials: | Titanium alloy Ti-6Al-4V (conform to ASTM<br>F136 and ISO 5832-3).<br>CP-titanium (conform to ASTM F67 and<br>ISO 5832-2).<br>Stainless steel and other instrument<br>materials |
| Function: | The implants of Alians Fragment Specific<br>range are indicated for hand and forearm<br>fractures, osteotomies and arthrodeses in<br>adults. |

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Image /page/5/Picture/1 description: The image shows a logo for Newclip Technics. The logo consists of a circle with the letters "nc" inside. The "t" in "nc" is stylized with an upward-pointing arrow. Below the circle, the words "NEWCLIP-TECHNICS" are written in a sans-serif font.

## 5. Substantial equivalence claimed to predicate devices:

The Alians Fragment Specific range is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performance.

## 6. Indications for Use:

The Alians Fragment Specific range is intended for hand and forearm fractures, osteotomies and arthrodeses in adults.

## 7. Non-clinical Test Summary:

The following tests were conducted:

- Comparative static bend test. (ASTM F382) ●
- Comparative fatigue bend test. (ASTM F382) .
- . Torsional test (ASTM F543)
- Insertion and removal test (ASTM F543) .
- Pull-out tests. (ASTM F543) •
- Endotoxins testing was performed using LAL quantitative kinetic . chromogenic method.

#### 8. Clinical Test Summary:

No clinical studies were performed.

#### 9. Conclusions Non-clinical and Clinical:

Newclip considers the Alians Fragment Specific range to be equivalent to the predicate devices listed above. This conclusion is based upon the device's similarities in principles of operation, technology, materials, and indications for use.