EasyClip Xpress

K162321 · Restore Surgical, LLC Dba Instratek · JDR · Feb 10, 2017 · Orthopedic

Device Facts

• Record ID: K162321
• Device Name: EasyClip Xpress
• Applicant: Restore Surgical, LLC Dba Instratek
• Product Code: JDR · Orthopedic
• Decision Date: Feb 10, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EasyClip XPress Staples are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

Device Story

EasyClip Xpress consists of superelastic bone staples and associated implantation instrumentation; used for bone fixation and joint arthrodesis in hand and foot surgery. Device implanted by surgeons in clinical settings. Staples provide mechanical stabilization of bone fragments; superelastic properties facilitate compression across osteotomy or arthrodesis sites. Benefit includes stabilization of bone segments to promote healing.

Clinical Evidence

No clinical data. Bench testing included dimensional analysis, engineering strength analysis, static and dynamic bending tests, corrosion testing per ASTM F2129, and bacterial endotoxin testing (LAL) meeting the 20 EU/device limit.

Technological Characteristics

Superelastic bone staples; associated implantation instrumentation. Materials conform to standards for orthopedic fixation. Testing includes ASTM F2129 for corrosion resistance.

Indications for Use

Indicated for patients requiring hand and foot bone fragment osteotomy fixation or joint arthrodesis.

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

• Stapix Superelastic Nitinol Fixation System (K133523)
• Stryker Memory Staple (K122113)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

Restore Surgical LLC, dba Instratek Mr. Jeff Seavey President 15200 Middlebrook Drive, Suite G Houston, Texas 77058

February 10, 2017

Re: K162321 Trade/Device Name: EasyClip Xpress 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: January 12, 2017 Received: January 13, 2017

Dear Mr. Seavey:

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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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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### SECTION 006: INDICATIONS FOR USE STATEMENT

#### 510(k) Number: K162321

Device Name: EasyClip Xpress

#### Indications for Use:

The EasyClip XPress Staples are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Restore Surgical LLC, dba Instratek

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## SECTION 007: 510(K) SUMMARY

| Submission Correspondent<br>and Owner: | Restore Surgical LLC, dba Instratek<br>15200 Middlebrook Dr., Suite G<br>Houston, TX 77058<br>USA<br><br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br>Contact: Mr. Jeff Seavey<br>President |
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| Date summary prepared: | August 11, 2016 |
| Device trade name: | EasyClip Xpress |
| Device classification name: | Staple, Fixation, Bone |
| Classification: | Class II |
| Product Code: | JDR |
| Regulation/Description: | 880.3030, Staple, Fixation, Bone |
| Predicate Devices | Stapix Superelastic Nitinol Fixation System (K133523)<br>Stryker Memory Staple (K122113). |
| Description of the device: | EasyClip Xpress is comprised of superelastic bone staples, as well<br>as associated instrumentation required for implantation of the<br>staples. |
| Intended use of the device: | The EasyClip Xpress is indicated for hand and foot bone<br>fragments osteotomy fixation and joint arthrodesis. |
| Technological<br>characteristics: | The proposed device has the same design, material, and intended<br>use as the predicate devices. |
| Testing: | Dimensional (geometric cross section) and engineering strength<br>analyses as well as static and dynamic bending tests were<br>conducted initially in K122113 and the results support the conclusion<br>that there are no effects of the modifications subject to this<br>premarket notification on the safety and effectiveness of the<br>EasyClip staples. Other testing performed: Corrosion Testing as per<br>ASTM F2129, Bacterial Endotoxins Test (LAL testing has been<br>performed to establish that the subject device meets the<br>specified 20 EU/device limit). |
| Conclusions: | The results of the comparison of design, materials, intended use and<br>technological characteristics demonstrate that the device is as safe<br>and effective as the legally marketed predicate devices. |

Restore Surgical LLC, dba Instratek