Alians Elbow Locking Plating System

K171372 · Newclip Technics · HRS · Jan 4, 2018 · Orthopedic

Device Facts

• Record ID: K171372
• Device Name: Alians Elbow Locking Plating System
• Applicant: Newclip Technics
• Product Code: HRS · Orthopedic
• Decision Date: Jan 4, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Alians Elbow Locking Plating System is intended for the fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults

Device Story

System consists of metallic plates and screws for internal bone fixation; used for fractures and osteotomies of distal humerus and proximal ulna in adults. Implants provided sterile or non-sterile for healthcare professional sterilization. Operates via mechanical stabilization of bone segments. Surgeon selects appropriate plate/screw configuration to achieve anatomical reduction and stability. Benefits include restoration of bone alignment and support for healing. Used in clinical/surgical settings.

Clinical Evidence

No clinical studies were performed. Substantial equivalence supported by non-clinical engineering analysis evaluating bending strength and stiffness.

Technological Characteristics

Materials: Titanium alloy Ti-6Al-4V (ASTM F 136 / ISO 5832-3). Components: Plates and screws for bone fixation. Sterilization: Gamma sterilization or healthcare professional sterilization.

Indications for Use

Indicated for fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults.

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

• Alians Elbow Locking Plating System (K152289)
• 3.5 Mm LCP Distal Humerus System of Synthes (K102998)
• May Humerus Plate of Turnkey Integration USA (K912936)
• Anatomic Locked Plating System Extra Long Plate Line Extension of Synthes (K103408)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

January 4, 2018

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

Re: K171372

Trade/Device Name: Alians Elbow 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: December 4, 2017 Received: December 5, 2017

Dear 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 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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Katherine D. Kavlock -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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# Indications for Use

510(k) Number (if known) K171372

#### Device Name

Alians Elbow Locking Plating System

Indications for Use (Describe)

The Alians Elbow Locking Plating System is intended for the fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K171372 Page 1/3

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. A red arrow points upwards to the right of the "t". Below the circle, the words "NEWCLIP - TECHNICS" are written in a sans-serif font.

#### 510 (k) Summary for the ALIANS ELBOW LOCKING 4. PLATING SYSTEM

In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the Alians Elbow Locking Plating System.

Summary preparation date: March 15, 2017

### 1. Submitter:

#### Contact Person:

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

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

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Image /page/4/Picture/1 description: The image is a logo for a company called "NEWCLIP-TECHNICS". The logo consists of a circle with the letters "nct" inside. The "t" is colored in red, and the rest of the letters are black. The words "NEWCLIP-TECHNICS" are written in a sans-serif font below the circle.

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

- . Alians Elbow Locking Plating System of Newclip Technics (K152289)
## Secondary predicate or legally marketed devices which are substantially equivalent:

- 3.5 Mm LCP Distal Humerus System of Synthes (K102998) .
- May Humerus Plate of Turnkey Integration USA (K912936) •
- Anatomic Locked Plating System Extra Long Plate Line Extension of . Synthes (K103408)
- The Alians Elbow Locking Plating system 4. Description of the device: consists of plates and screws, designed for the fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults.

The implants of the Alians Elbow Locking Plating System will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization.

The instruments of the Alians Elbow Locking Plating System range will be provided non sterile for sterilization by health care professionals prior to use or sterile.

of fractures and osteotomies of the distal humerus and the proximal ulna in adults.

Materials: Titanium alloy Ti-6Al-4V (conform to ASTM F 136 and/or ISO 5832-3). The implants of the Alians Elbow Locking Function: Plating System are intended for the fixation

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Image /page/5/Picture/1 description: The image is a logo for a company called "NEWCLIP-TECHNICS". The logo consists of a circle with the letters "nct" inside. The "t" in "nct" has an arrow pointing upwards. The words "NEWCLIP-TECHNICS" are written in all caps below the circle.

## 5. Substantial equivalence claimed to predicate devices:

The Alians Elbow Locking Plating System is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety, and performances.

### 6. Indications for use:

The Alians Elbow Locking Plating System is intended for the fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults.

## 7. Non-clinical Test Summary:

Engineering analysis was performed to evaluate the bending strength and bending stiffness of the subject device plates compared to predicates.

Engineering analysis was performed to evaluate the removable support compared to predicates.

## 8. Clinical Test Summary:

No clinical studies were performed.

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

Newclip considers the Alians Elbow Locking Plating System 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.