Arcus Staple System

K151160 · Nextremity Solutions, Inc. · JDR · Sep 4, 2015 · Orthopedic

Device Facts

• Record ID: K151160
• Device Name: Arcus Staple System
• Applicant: Nextremity Solutions, Inc.
• Product Code: JDR · Orthopedic
• Decision Date: Sep 4, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nextremity Solutions Arcus™ Staple System is indicated for fixation of bone fractures, bone reconstruction, ligament, soft tissue and tendon. Examples include: - Fixation of bone fragments or small bones fractures . - . Fracture management in the foot and hand

Device Story

The Arcus™ Staple System is a metallic bone fixation device used by orthopedic surgeons in clinical settings. It consists of a bone staple and associated surgical instruments for site preparation and insertion. The system is used to stabilize bone fragments or small bone fractures and assist in bone reconstruction or soft tissue/tendon attachment. The surgeon uses the provided instruments to prepare the surgical site and insert the staple to provide mechanical fixation. This stabilization facilitates bone healing and structural integrity in the foot and hand.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F-564, including static and dynamic 4-point bending tests and pull-out force testing.

Technological Characteristics

Metallic bone fixation staple fabricated from medical grade Titanium (ASTM F-136). System includes manual surgical instruments for sizing, preparation, and insertion. Mechanical performance validated per ASTM F-564.

Indications for Use

Indicated for fixation of bone fractures, bone reconstruction, and attachment of ligament, soft tissue, and tendon, specifically for fracture management in the foot and hand.

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

• Z-Medical, Z-Guide Staple System (K121277)
• Memometal Technologies, Varisation Staple (K070033)

Submission Summary (Full Text)

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

Nextremity Solutions, Incorporated Mr. Ryan Schlotterback Official Correspondent 54 Broad Street, Suite 200 Red Bank, New Jersey 07701

September 4, 2015

Re: K151160 Trade/Device Name: Arcus™ Staple System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: August 11, 2015 Received: August 12, 2015

Dear Mr. Schlotterback:

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in 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,

# 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 Statement

510(k) Number: K151160

Device Name: Arcus™ Staple System

Indications For Use:

The Nextremity Solutions Arcus™ Staple System is indicated for fixation of bone fractures, bone reconstruction, ligament, soft tissue and tendon.

Examples include:

- ・ Fixation of bone fragments or small bones fractures
- . Fracture management in the foot and hand

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

### Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary (Per 21 CFR 807.92)

| General Company Information: | Nextremity Solutions, Inc.<br>Ryan Schlotterback<br>210 North Buffalo Street<br>Warsaw, IN 46580 |
|------------------------------|--------------------------------------------------------------------------------------------------|
| Date Prepared | August 11, 2015 |

General Device Information

| Product Name: | Arcus™ Staple System |
|-----------------|---------------------------------------------------------------------------------------------------------------------------|
| Classification: | Single/multiple component metallic<br>bone fixation appliances and<br>accessories<br>21 CFR 888.3030<br>Product code: JDR |

Predicate Devices

| Z-Medical, GmbH | Z-Medical, Z-Guide Staple System<br>(Marketed as Z-Staple)<br>[510(k) K121277] |
|------------------------|--------------------------------------------------------------------------------|
| Memometal Technologies | Varisation Staple<br>(Marketed as Varisation Staple)<br>[510(k) K070033] |

# Description

The Nextremity Solutions Arcus™ Staple System is a set, consisting of:

- 1. A bone staple.
- 2. Necessary surgical site sizing, preparation and insertion instruments (as a procedure pack).

The staples are fabricated from medical grade Titanium (ASTM F-136).

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## Intended Use (Indications)

The Nextremity Solutions Arcus™ Staple System is indicated for fixation of bone fractures, bone reconstruction, ligament, soft tissue and tendon.

Examples include:

- Fixation of bone fragments or small bones fractures .
- . Fracture management in the foot and hand

## Substantial Equivalence

The Nextremity Solutions, Arcus™ Staple System possesses the same technological characteristics as the predicate devices. These characteristics include the intended use, basic design, material, size and fundamental technology.

### Performance Data

Mechanical testing was performed as described in relevant recognized standards, including testing for 4 point bending (static and dynamic) and pull-out force for the Arcus™ Staple System as per ASTM F-564.