EPIC Extremely Small Staple

K163226 · Epic Extremely, LLC · JDR · May 16, 2017 · Orthopedic

Device Facts

• Record ID: K163226
• Device Name: EPIC Extremely Small Staple
• Applicant: Epic Extremely, LLC
• Product Code: JDR · Orthopedic
• Decision Date: May 16, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EPIC Extremity Small Staple is indicated for use in fixation of bone fractures or bone reconstruction. Examples Include: *Wedge osteotomy of the first phalanx (Akin osteotomy) *Treatment of hallux valgus in order to correct valgus or pronation of the first ray *Wind swept toes The Small Staple is intended for single use only.

Device Story

EPIC Extremity Small Staple is a metallic bone fixation implant; used for bone fractures or reconstruction (e.g., Akin osteotomy, hallux valgus correction). Device consists of a single size/style staple and associated implantation instruments. Intended for single use. Operates as a mechanical fixation device to stabilize bone segments. Used by orthopedic surgeons in clinical settings. Benefits include bone stabilization during healing. No software or electronic components.

Clinical Evidence

No clinical testing was required. Substantial equivalence is supported by non-clinical bench testing (static bend, fatigue bend, and pullout testing) conducted in accordance with ASTM F-564-10.

Technological Characteristics

Metallic bone fixation staple. Materials are identical to predicate devices. Performance testing conducted per ASTM F-564-10 (static bend, fatigue bend, pullout).

Indications for Use

Indicated for bone fracture fixation or bone reconstruction, including Akin osteotomy, hallux valgus correction, and wind swept toes.

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

• Compression Staple and Simple Staple (K043059)
• Sniper Staple System (K162354)

Reference Devices

• Wright Medical Simple Staple

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

May 16, 2017

Epic Extremely, LLC Randy Schlemmer Director Of New Product Development 120 Marguerite Drive, Suite 301 Cranberry Township, Pennsylvania 16066

Re: K163226

Trade/Device Name: EPIC Extremely Small Staple 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: April 17, 2017 Received: April 20, 2017

Dear Mr. Schlemmer:

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

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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,

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) K163226

Device Name EPIC Extremity Small Staple

Indications for Use (Describe)

The EPIC Extremity Small Staple is indicated for use in fixation of bone fractures or bone reconstruction. Examples include:

* Wedge osteotomy of the first phalanx (Akin osteotomy)

* Treatment of hallux valgus in order to correct valgus or pronation of the first ray

* Wind swept toes

The Small Staple is intended for single use only

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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K163226

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Image /page/3/Picture/2 description: The image shows the word "EPIC" in large, bold, black letters. Below the word "EPIC" is the word "EXTREMITY" in a smaller font. There is a blue swoosh design that underlines the word "EXTREMITY".

# 510(k) Summary

## Submitter Information

| Applicant: | EPIC Extremity, LLC<br>120 Marguerite Drive, Suite 301<br>Cranberry Twp., PA 16066 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Randy Schlemmer<br>EPIC Extremity, LLC<br>120 Marguerite Drive, Suite 301<br>Cranberry Twp., PA 16066<br>[phone] |
| Date Prepared: | November 16th, 2016 |
| Name of Device: | EPIC Extremity Small Staple |
| Common Name: | Staple, Fixation, Bone |
| Classification Name: | Single/multiple component metallic bone fixation appliances<br>and accessories (per 21 CFR 888.3030) - Class II |
| Product Code/Panel: | JDR/Orthopedics/87 |
| Predicate Devices: Primary - | Compression Staple and Simple<br>Staple (K043059)<br>Secondary - Sniper Staple System (K162354) |

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K163226

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Image /page/4/Picture/2 description: The image shows the logo for Epic Extremity. The word "EPIC" is in large, bold, black letters. Below that, the word "EXTREMITY" is in smaller, white letters on a blue background.

## 510(k) Summary

#### Intended Use:

The EPIC Extremity Small Staple is indicated for use in fixation of bone fractures or bone reconstruction.

Examples Include:

*Wedge osteotomy of the first phalanx (Akin osteotomy)

*Treatment of hallux valgus in order to correct valgus or pronation of the first ray *Wind swept toes

The Small Staple is intended for single use only.

#### Device Description

The EPIC Extremity Small Staple will consist of one size and style, and instruments to assist in implanting the device.

## Technological Characteristics

The EPIC Extremity Small Staple

- has the same intended use as the predicate device. .
- has similar indications for use as the predicate device. ●
- is manufactured from the same materials as the predicate device.
- range of sizes of the is similar to the predicate device. ●

#### Non-Clinical Performance Data Summary

ASTM F-564-10 Static bend testing, fatigue bend testing, and pullout testing of the subject device performance was compared to predicate performance.

## Clinical Performance Data Summary

No clinical testing was required.

## Non-Clinical and Clinical Performance Data Conclusions

Based on testing results and the comparisons provided, the EPIC Extremity Small Staple is considered substantially equivalent to the Wright Medical Simple Staple in material, construction, and performance characteristics.