Large Screws Range

K172596 · Newclip Technics · HWC · Oct 2, 2017 · Orthopedic

Device Facts

• Record ID: K172596
• Device Name: Large Screws Range
• Applicant: Newclip Technics
• Product Code: HWC · Orthopedic
• Decision Date: Oct 2, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Large Screws range is indicated for the fixation of bone fractures, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults.

Device Story

Large Screws Range consists of metallic screws and washers for orthopedic fixation; used for bone fractures, pseudarthroses, fusions, and osteotomies. Implants and associated instruments are provided either non-sterile (requiring healthcare professional sterilization) or sterile (gamma sterilization). Device used in clinical settings by surgeons for internal bone fixation. Output is physical stabilization of bone fragments to facilitate healing. Benefits include structural support for bone segments during recovery.

Clinical Evidence

No clinical studies were performed. Evidence consists of engineering analyses and bench testing (LAL endotoxin testing).

Technological Characteristics

Materials: Titanium alloy Ti-6Al-4V (ASTM F136, ISO 5832-3). Components: Screws and washers. Sterilization: Gamma sterilization or user-performed sterilization for non-sterile components.

Indications for Use

Indicated for fixation of bone fractures, pseudarthroses, fusions, and osteotomies of foot, ankle, and medium/large bone fragments (radius, humerus, femur, tibia) in adults.

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

• Large Screws Range of Newclip Technics (K160617)
• Asnis III Cannulated Screw System of Howmedica Osteonics Corp. (K000080 and K024060)

Reference Devices

• Activ Ankle Locking Plating System of Newclip Technics (K143061)

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

October 2, 2017

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

Re: K172596

Trade/Device Name: Large Screws Range Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: August 24, 2017 Received: September 5, 2017

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 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

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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 (DICE) 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely.

# 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) K172596

#### Device Name

Large Screws range

Indications for Use (Describe)

The Large Screws range is indicated for the fixation of bone fractures, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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Expiration Date: January 31, 2017

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Image /page/3/Picture/1 description: The image shows a logo for a company called NEWCLIP-TECHNICS. The logo features the letters 'nc' in a circle, with the 't' in 'nc' being stylized with an upward-pointing arrow. The company name is written in all caps below the circle.

#### 510 (k) Summary for the LARGE SCREWS RANGE 4.

In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the Large Screws Range.

Summary preparation date: August , 2017

| 1. Submitter: | Contact Person: |
|-------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| NEWCLIP TECHNICS<br>P.A. de la Lande Saint Martin<br>45 rue des Garottières<br>F-44115 Haute-Goulaine - France<br>Telephone: [phone] | J.D. Webb<br>The OrthoMedix Group, Inc.<br>1001 Oakwood Blvd<br>Round Rock, TX 78681<br>Telephone: [phone] |
| 2. Trade Name: | Large Screws Range |
| Common Name: | Large Screws |
| Product Code: | HWC |

#### Classification Name: Smooth or threaded metallic bone fixation fastener. (21 CFR part. 888.3040)

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

- . Large Screws Range of Newclip Technics (K160617)
### Secondary predicate or legally marketed devices which are substantially equivalent:

- Asnis III Cannulated Screw System of Howmedica Osteonics Corp. . (K000080 and K024060)
#### Reference device:

- Activ Ankle Locking Plating System of Newclip Technics (K143061) .

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Image /page/4/Picture/1 description: The image shows a logo for New Clip-Technics. The logo consists of a circle with the letters "nct" inside. The "t" is colored in pink. Below the circle, the words "NEW CLIP-TECHNICS" are written in a sans-serif font.

| 4. Description of the device: | The Large Screws range consists of screws and washers designed for the fixation of bone fractures, pseudarthroses, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults. |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The implants of the Large Screws Range will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. |
| | The instruments of the Large Screws Range will be provided non sterile for sterilization by health care professionals prior to use. Single use kits (Initial S) containing implants and/or instruments will be provided sterile by gamma sterilization. Additional sterile instruments will also be provided sterile by gamma sterilization. |
| Materials: | Titanium alloy Ti-6Al-4V (conform to ASTM F136 and ISO 5832-3). |
| Function: | The implants of the Large Screws range are indicated for the fixation of bone fractures, pseudarthroses, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia |

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

in adults.

The Large Screws Range is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety, and performances.

### 6. Indications for use:

The Large Screws range is indicated for the fixation of bone fractures, pseudarthroses, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in 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 'nct' inside. The 't' has an upward-pointing arrow in red. Below the circle, the words 'NEWCLIP-TECHNICS' are written in a sans-serif font.

### 7. Non-clinical Test Summary:

Engineering analyses have been conducted in comparison with Large Screws Range of Newclip Technics (K160617).

LAL testing was performed to demonstrate that the subject device meets the endotoxin limit of <20 EU/device.

## 8. Clinical Test Summary:

No clinical studies were performed.

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

Newclip Technics considers the Large Screws 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.