DePuy Synthes Static Staples

K180544 · Synthes (USA) Products, LLC · JDR · Jul 24, 2018 · Orthopedic

Device Facts

• Record ID: K180544
• Device Name: DePuy Synthes Static Staples
• Applicant: Synthes (USA) Products, LLC
• Product Code: JDR · Orthopedic
• Decision Date: Jul 24, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy Synthes Static Staples are indicated for extra-articular closing-wedge osteotomies of the 1st ray of the forefoot.

Device Story

DePuy Synthes Static Staples are metallic bone fixation implants designed for extra-articular closing-wedge osteotomies of the 1st ray of the forefoot. The device is provided in 26° and 90° configurations to accommodate varying patient anatomy. It is supplied in a disposable, sterile kit, preloaded onto a handheld inserter, and includes a drill guide and K-wires. Used in an operating room setting by a surgeon, the staple provides mechanical fixation to stabilize bone segments following an osteotomy. The device benefits patients by maintaining bone alignment during the healing process.

Clinical Evidence

No clinical data. Substantial equivalence was determined based on non-clinical performance data, including static bending, dynamic bending, and pull-out testing conducted per ASTM F564, as well as MRI conditional testing.

Technological Characteristics

Metallic bone fixation staple. Configurations: 26° and 90°. Testing standards: ASTM F564 (static/dynamic bending, pull-out). MRI conditional. Supplied sterile in a disposable kit with handheld inserter, drill guide, and K-wires.

Indications for Use

Indicated for patients requiring extra-articular closing-wedge osteotomies of the 1st ray of the forefoot.

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

• Zimmer Biomet Varisation Staple (K931155)
• Trilliant Surgical Sniper Staple System (K162354)
• EPIC Extremity Small Staple (K163226)

Reference Devices

• Synthes (USA) 1.5mm Mini Fragment LCP System (K090047)

Submission Summary (Full Text)

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Synthes (USA) Products, LLC Suchitra Basu Global Strategy Manager, Regulatory Affairs 1301 Goshen Parkway West Chester, Pennsylvania 19380

July 24, 2018

## Re: K180544

Trade/Device Name: DePuy Synthes Static Staples 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 22, 2018 Received: June 25, 2018

Dear Suchitra Basu:

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

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K180544

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 | | |
|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Food and Drug Administration | Expiration Date: 06/30/2020 | | |
| | See PRA Statement below. | | |
| 510(k) Number (if known) | K180544 | | |
| Device Name | DePuy Synthes Static Staples | | |
| Indications for Use (Describe) | The DePuy Synthes Static Staples are indicated for extra-articular closing-wedge osteotomies of the 1st ray of the forefoot. | | |
| Type of Use (Select one or both, as applicable) | <table style="border:none;"><tr><td><div> <span> <label><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </span> </div></td><td><div> <span> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </span> </div></td></tr></table> | <div> <span> <label><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </span> </div> | <div> <span> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </span> </div> |
| <div> <span> <label><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </span> </div> | <div> <span> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </span> </div> | | |

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## 510(k) Summary

## Date Prepared: July 23, 2018

| Sponsor | DePuy Synthes<br>Suchitra Basu, PhD, RAC<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>Phone: [phone] |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | July 23, 2018 |
| Proprietary Name | DePuy Synthes Static Staples |
| Common or Usual<br>Name(s) | Bone Staple, Staple, Accessories |
| Classification Name | Single/multiple component metallic bone fixation appliances and accessories |
| Classification | Class II<br>Regulation Number: 21 CFR 888.3030<br>Product Code: JDR |
| Predicate Devices | Primary Predicate: Zimmer Biomet Varisation Staple (K931155)<br>Additional Predicates: Trilliant Surgical Sniper Staple System (K162354),<br>EPIC Extremity Small Staple (K163226) |
| Reference Device | Synthes (USA) 1.5mm Mini Fragment LCP System (K090047) |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain<br>clearance for the DePuy Synthes Static Staples. |

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T

| Device Description | The DePuy Synthes Static Staple is an implant for bone fixation designed for<br>extra-articular closing wedge osteotomies of the 1st ray of the forefoot.<br>The implant is offered in two (2) configurations of 26° and 90° to address<br>varying patient anatomy of the foot, particularly the 1st ray of the forefoot.<br>The Static Staple implant is delivered to the operating room in a disposable,<br>sterile kit, preloaded onto a handheld inserter along with drill guide and K-<br>wires. |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The DePuy Synthes Static Staples are indicated for extra-articular closing<br>wedge osteotomies of the 1st ray of the forefoot. |

## (1) DePuy Synthes

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| Non-clinical<br>Performance Data | The following analysis were conducted:<br>Static Bend according to ASTM F564 Dynamic bending according to ASTM F564 Pull-out testing according to ASTM F564 MRI Conditional Testing to establish MR Conditional parameters |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical<br>Performance Data | Clinical testing was not necessary for the determination of substantial equivalence. |

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| | The Static Staples implants possess the equivalent technological<br>characteristics as that of the primary predicate devices (K931155). These<br>include:<br>performance, basic design, material and sizes (dimensions are comparable to those offered by the predicate systems). |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial<br>Equivalence | The proposed device has indications for use which are fully encompassed by<br>the indications for use of the predicate device.<br>The mechanical testing and analytical evaluation included in this submission<br>demonstrate that:<br>Any differences in technological characteristics of the subject devices do not raise any new questions of safety and effectiveness. The proposed devices are at least as safe and effective as the predicate devices. Based on the indications for use, technological characteristics, and the<br>summary of data submitted, it is concluded that the information provided in<br>this submission supports substantial equivalence. |