Footmotion Plating System

K161448 · Newclip Technics · HRS · Oct 31, 2016 · Orthopedic

Device Facts

• Record ID: K161448
• Device Name: Footmotion Plating System
• Applicant: Newclip Technics
• Product Code: HRS · Orthopedic
• Decision Date: Oct 31, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Footmotion Plating System is intended for arthrodeses, fractures and osteotomies fixation surgeries of the foot in adults.

Device Story

Footmotion Plating System consists of titanium alloy plates and screws; used for bone fixation in foot arthrodeses, fractures, and osteotomies. Implants provided non-sterile for healthcare professional sterilization or sterile via gamma radiation. System utilized by orthopedic surgeons in clinical/surgical settings to stabilize bone segments; facilitates healing through rigid fixation. Output is physical stabilization of bone; clinical decision-making relies on surgeon assessment of fracture/deformity. Benefits include restoration of skeletal alignment and support for bone union.

Clinical Evidence

No clinical studies were performed. Evidence is based on non-clinical bench testing, including comparative fatigue compression (ASTM F382), static tests (ASTM F382), torsional tests (ASTM F543), engineering analysis, and endotoxin testing (LAL quantitative kinetic chromogenic method).

Technological Characteristics

Materials: Titanium alloy Ti-6Al-4V ELI (ASTM F 136-13/ISO 5832-3). Components: Plates and screws. Sterilization: Gamma sterilization or healthcare facility steam sterilization. Mechanical testing: ASTM F382 (fatigue/static), ASTM F543 (torsional).

Indications for Use

Indicated for arthrodeses, fractures, and osteotomies fixation and revision surgeries of the foot 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

• Anchorage® Bone Plate System of Memometal (K083447)
• Ortholoc® 3Di Midfoot/Flatfoot System of Wright Medical Technology (K121651)
• Plantar Lapidus Plate System 2.7/3.5 of Normed (K152256)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected and appear to be emerging from a single base. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

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

October 31, 2016

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

Re: K161448

Trade/Device Name: Footmotion 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: September 16, 2016 Received: September 20, 2016

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - J.D. Webb

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,

# Lori A. Wiggins -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)

K161448

Device Name

Footmotion Plating System

Indications for Use (Describe)

The Footmotion Plating System is intended for arthrodeses, fractures and osteotomies fixation surgeries of the foot in adults.

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/1 description: The image shows the logo for NEWCLIP-TECHNICS. The logo features the letters "nct" inside of a circle. The "t" in "nct" is red and has an arrow pointing upwards. Below the circle, the words "NEWCLIP-TECHNICS" are written in all caps.

# 510 (k) Summary for the Footmotion Plating System

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

Summary preparation date: October 18, 2016

| Submitter:<br>1. | 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: | Footmotion Plating System |
| Common Name: | Plates for foot fractures, osteotomies and<br>arthrodeses<br>Screws associated<br>Instrumentation associated |
| 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<br>fixation fastener.(21 CFR part. 888.3040) |

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Image /page/4/Picture/1 description: The image is a logo for NEWCLIP-TECHNICS. The logo features the letters "nct" inside of a circle. The "t" in "nct" has been stylized to look like an upward-pointing arrow and is a different color than the other letters.

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

- The Anchorage® Bone Plate System of Memometal (K083447), .
## Secondary predicate or legally marketed devices which are 4. substantially equivalent:

- The Ortholoc® 3Di Midfoot/Flatfoot System of Wright Medical . Technology (K121651),
- The Plantar Lapidus Plate System 2.7/3.5 of Normed (K152256). .

| 5. | <b>Description of the device:</b> | The Footmotion Plating System consists of a plate with as many screws as holes (slots) designed for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults. The plates and screws are manufactured from titanium alloy and color anodized. |
|----|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | The Footmotion Plating System will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. |
| | <b>Materials:</b> | Titanium alloy Ti-6Al-4V ELI (conforms to ASTM F 136-13 and/or ISO 5832-3). |
| | <b>Function:</b> | The implants of the Footmotion Plating System are indicated for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults. |

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Image /page/5/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, the words "NEWCLIP-TECHNICS" are written in a sans-serif font. The logo is simple and modern.

#### 6. Substantial equivalence claimed to predicate devices:

The Footmotion Plating System is substantially equivalent to the Anchorage® Plate System of Memometal (K083447), the Ortholoc® 3Di Bone Midfoot/Flatfoot System of Wright Medical Technology (K121651) and the Plantar Lapidus Plate System 2.7/3.5 of Normed (K152256) in terms of intended use, design, materials used, mechanical safety and performance.

#### 7. Intended use:

The Footmotion Plating System is indicated for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults.

#### Non-clinical Test Summary: 8.

The following tests were conducted:

- Comparative fatigue compression tests. (ASTM F382) .
- Comparative static tests. (ASTM F382) .
- Torsional tests. (ASTM F543) .
- Engineering analysis. .
- Endotoxin testing is performed using the LAL quantitative kinetic . chromogenic method. Testing is performed on worst case representatives from the company's products. The testing demonstrated that the subject devices meet the recommended maximum endotoxin level of 20 EU per device.
- . Since water used in the cleaning steps is a possible source of endotoxin, testing is performed on the water and includes bioburden, TOC, THC, and LAL. The maximum limit for endotoxin level is established at 0.25 EU/mL and has never been reached.

### 9. Clinical Test Summary:

No clinical studies were performed.

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

The Footmotion Plating System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.