Arthrex Compression Screws

K170382 · Arthrex, Inc. · HWC · May 11, 2017 · Orthopedic

Device Facts

• Record ID: K170382
• Device Name: Arthrex Compression Screws
• Applicant: Arthrex, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: May 11, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex Compression Screws are intended for fixation of fractures, osteotomies and arthrodesis in: - carpal, metacarpal and small hand bones . - . tarsal and metatarsals - . phalanges - . intra-articular fractures - . ankle - . proximal and distal humerus - . proximal and distal radius - . proximal and distal ulna - . osteochondral fixation and fractures - . osteochondritis dissecans - . fixation of fractures and osteotomies about the knee - . oblique fractures of the fibula - . reconstructive surgeries of the foot - malleolar fixation where size of offered implant is patient appropriate.

Device Story

Arthrex Compression Screws are titanium, cannulated, fully threaded bone fixation fasteners; diameter range 5.0-7.0mm; length range 20-140mm. Device used by orthopedic surgeons in clinical settings for bone fixation, osteotomies, and arthrodesis. Implant provides mechanical compression across fracture or osteotomy sites to facilitate healing. Device is a line extension of previously cleared compression screws; performance verified via bench testing.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified through mechanical testing including shear, push-out, torque, and compression tests. Device meets pyrogen limit specifications.

Technological Characteristics

Titanium, cannulated, fully threaded bone screws. Diameter 5.0-7.0mm; length 20-140mm. Mechanical fixation device.

Indications for Use

Indicated for fixation of fractures, osteotomies, and arthrodesis in carpal, metacarpal, small hand bones, tarsal, metatarsals, phalanges, ankle, humerus, radius, ulna, knee, and fibula; applicable for intra-articular fractures, osteochondral fixation, osteochondritis dissecans, and foot reconstructive surgeries.

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

• Arthrex Compression FT Screws (K132217)

Reference Devices

• Arthrex Fracture Plates (K123241)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows a partial view of the Department of Health & Human Services (HHS) logo. The text "DEPARTMENT OF HEALTH & HUMAN" is visible, arranged in a circular fashion. To the right of the text, the HHS symbol, consisting of a stylized human figure, is also partially visible.

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

May 11, 2017

Arthrex Inc. Mr. David L. Rogers Project Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, FL 34108

Re: K170382

Trade/Device Name: Arthrex Compression Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: April 11, 2017 Received: April 14, 2017

Dear Mr. Rogers:

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 device

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related 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,

# 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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### Indications for Use

510(k) Number (if known) K170382

#### Device Name

Arthrex Compression Screws

Indications for Use (Describe)

The Arthrex Compression Screws are intended for fixation of fractures, osteotomies and arthrodesis in:

- carpal, metacarpal and small hand bones .
- . tarsal and metatarsals
- . phalanges
- . intra-articular fractures
- . ankle
- . proximal and distal humerus
- . proximal and distal radius
- . proximal and distal ulna
- . osteochondral fixation and fractures
- . osteochondritis dissecans
- . fixation of fractures and osteotomies about the knee
- . oblique fractures of the fibula
- . reconstructive surgeries of the foot
- malleolar fixation

where size of offered implant is patient appropriate.

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

| <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|-------------------------------------------------------------|------------------------------------------------------------|
|-------------------------------------------------------------|------------------------------------------------------------|

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## 510(k) Summary

| Date Prepared | May 9, 2017 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Arthrex Inc. |
| | 1370 Creekside Boulevard |
| | Naples, FL 34108-1945 |
| Contact Person | David L Rogers |
| | Project Manager, Regulatory Affairs |
| | 1-239-643-5553, ext. 71924 |
| | [e-mail] |
| Name of Device | Arthrex Compression Screws |
| Common Name | Screw, fixation, bone |
| Product Code | HWC |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Regulatory Class | II |
| Primary Predicate Device | K132217: Arthrex Compression FT Screws |
| Reference Predicate Device | K123241: Arthrex Fracture Plates |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to obtain clearance for a<br>line extension to the Arthrex Compression Screw family cleared under K132217. |
| Device Description | The Arthrex Compression Screws are a family of titanium, cannulated,<br>compression screws that are offered in a diameter range of 5.0 to 7.0mm, length<br>range of 20 to 140mm, in a fully threaded design. |
| Indications for Use | The Arthrex Compression Screws are intended for fixation of fractures,<br>osteotomies and arthrodesis in:<br>carpal, metacarpal and small hand bones tarsal and metatarsals phalanges intra-articular fractures ankle proximal and distal humerus proximal and distal radius proximal and distal ulna osteochondral fixation and fractures osteochondritis dissecans fixation of fractures and osteotomies about the knee oblique fractures of the fibula reconstructive surgeries of the foot malleolar fixation where size of offered implant is patient appropriate. |
| Performance Data | Shear, push-out, torque, and compression testing were conducted to<br>demonstrate that the proposed compression screws perform statistically<br>equivalent to the predicate. |
| | the device meets pyrogen limit specifications. |
| Conclusion | The Arthrex Compression Screws are substantially equivalent to the predicate<br>device in which the basic design features and intended uses are the same. Any<br>differences between the proposed device and the predicate device are<br>considered minor and do not raise questions concerning safety or effectiveness. |
| | Based on the indications for use, technological characteristics, and the summary<br>of data submitted, Arthrex Inc. has determined that the proposed device is<br>substantially equivalent to the currently marketed predicate device. |

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