EasyStep

K160813 · Stryker GmbH · JDR · Jul 26, 2016 · Orthopedic

Device Facts

• Record ID: K160813
• Device Name: EasyStep
• Applicant: Stryker GmbH
• Product Code: JDR · Orthopedic
• Decision Date: Jul 26, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EasyStep system is intended for bone fragment and osteotomy fixation of the foot in adult patients. Indications include: - Bone fragment fixation - Osteotomy fixation

Device Story

EasyStep system consists of superelastic Nitinol (Nickel-Titanium alloy) staples used for bone fragment and osteotomy fixation in the foot. Staples feature barbed legs for bone anchorage and are provided sterile. Device is used by surgeons in clinical settings to stabilize bone segments following osteotomy or fracture. Principle of operation relies on the superelastic properties of Nitinol to provide compression across the fixation site. Clinical benefit includes stabilization of bone fragments to facilitate healing. No software or electronic components involved.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing including pull-out testing (ASTM F564), four-point bending (ASTM F564), cyclic potentiodynamic polarization (ASTM F2129), bacterial endotoxins testing (ANSI/AAMI ST72), and MRI compatibility assessments (ASTM F2052, F2213, F2182, F2119).

Technological Characteristics

Superelastic staples fabricated from Nitinol (Nickel-Titanium alloy) per ASTM F2063. Sizes range 4 mm to 12 mm. Barbed leg design for bone anchorage. Sterile. Mechanical fixation principle. MRI compatible.

Indications for Use

Indicated for bone fragment and osteotomy fixation of the foot in adult patients.

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

• Biomedical Enterprises Inc. Memograph Staple System (K993714)

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

July 26, 2016

Stryker GmbH Garry Hayeck, Ph.D. Associate Manager. Regulatory Affairs 325 Corporate Drive Mahwah, New Jersey 07430

Re: K160813 Trade/Device Name: EasyStep 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: June 24, 2016 Received: June 27, 2016

Dear Dr. Hayeck:

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 Parts 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 (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" (21CFR 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,

# Vincent J. Devlin -S

for

- 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) K160813

Device Name EasyStep

Indications for Use (Describe)

The EasyStep system is intended for bone fragment and osteotomy fixation of the foot in adult patients. Indications include:

- · Bone fragment fixation
- Osteotomy fixation

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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| Submission Number: | K160813 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | EasyStep |
| Common Name: | Staple, fixation, bone |
| Regulation Description: | Single/multiple component metallic bone fixation appliance<br>and accessories |
| Regulation Number: | 21 CFR 888.3030 |
| Product Code: | JDR |
| Device Class: | Class II |
| Sponsor: | Stryker GmbH<br>Bohnackerweg 1<br>2545 Selzach / Switzerland |
| Contact Person: | Garry T. Hayeck, Ph.D.<br>Associate Manager, Regulatory Affairs<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | July 22, 2016 |
| Primary Predicate: | Biomedical Enterprises Inc. Memograph Staple System<br>(K993714) |

510(k) Summary

#### Description

The Stryker GmbH EasyStep system includes superelastic staples fabricated from Nitinol (Nickel-Titanium alloy) per ASTM F 2063. The staples range in size from 4 mm to 12 mm in 2 mm increments where the staple size refers to the step size associated with each staple. The legs of each staple are barbed to provide anchorage within the bone fragments. All implants within the system are provided sterile.

#### Indications for Use

The EasyStep system is intended for bone fragment and osteotomy fixation of the foot in adult patients.

Indications include:

- Bone fragment fixation
- Osteotomy fixation

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### Summary of Technologies

A comparison of the systems demonstrated that the subject EasyStep system is substantially equivalent to the Biomedical Enterprises Inc. Memograph Staple System in regards to intended use, material, design, and operational principles.

## Non-Clinical Testing

Non-clinical laboratory testing was performed on the worst case subject staples to determine substantial equivalence. Testing demonstrated that the EasyStep system is equivalent in mechanical performance to the predicate device, the Biomedical Enterprises, Inc. Memograph Staple System.

The following testing was performed:

- Pull-Out Testing per ASTM F564 .
- Four-Point Bending Testing per ASTM F564
- Cyclic Potentiodynamic Polarization (Corrosion) Test per ASTM F2129
- Bacterial Endotoxins Test (BET) per ANSI/AAMI ST72

Testing to determine the compatibility of the EasyStep system in an MR environment was also performed. These tests included an assessment of:

- Magnetically Induced Displacement Force per ASTM F2052
- . Magnetically Induced Torque per ASTM F2213
- Heating by RF Fields per ASTM F2182
- Image Artifacts per ASTM F 2119

#### Clinical Testing

Clinical testing was not required for this submission.

#### Conclusion

The subject EasyStep system is substantially equivalent to the predicate Biomedical Enterprises Inc. Memograph Staple System.