K Number
K180544
Device Name
DePuy Synthes Static Staples
Date Cleared
2018-07-24

(145 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DePuy Synthes Static Staples are indicated for extra-articular closing-wedge osteotomies of the 1st ray of the forefoot.
Device Description
The DePuy Synthes Static Staple is an implant for bone fixation designed for extra-articular closing wedge osteotomies of the 1st ray of the forefoot. The implant is offered in two (2) configurations of 26° and 90° to address varying patient anatomy of the foot, particularly the 1st ray of the forefoot. The Static Staple implant is delivered to the operating room in a disposable, sterile kit, preloaded onto a handheld inserter along with drill guide and K-wires.
More Information

No
The device description and performance studies focus on the mechanical properties and surgical application of a bone fixation staple, with no mention of AI or ML technologies.

No
The device is an implant for bone fixation, specifically for extra-articular closing-wedge osteotomies, which is a surgical procedure to correct deformities, not a therapeutic device for ongoing treatment.

No
The device is an implant for bone fixation used in osteotomies of the foot, not for diagnosing medical conditions.

No

The device description clearly states it is an implant for bone fixation and is delivered in a sterile kit with a handheld inserter, drill guide, and K-wires, indicating it is a physical hardware device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for "extra-articular closing-wedge osteotomies of the 1st ray of the forefoot." This describes a surgical procedure performed directly on the patient's bone.
  • Device Description: The device is described as an "implant for bone fixation." Implants are devices placed within the body.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.

IVD devices are used to perform tests on samples taken from the body to provide information about a person's health. This device is a surgical implant used to fix bone during a procedure.

N/A

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

JDR

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

1st ray of the forefoot

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical Performance Data: The following analysis were conducted: 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 Performance Data: Clinical testing was not necessary for the determination of substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K931155, K162354, K163226

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K090047

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
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.(b)
Classification. Class II.

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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.

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

DEPARTMENT OF HEALTH AND HUMAN SERVICESForm Approved: OMB No. 0910-0120
Food and Drug AdministrationExpiration Date: 06/30/2020
See PRA Statement below.
510(k) Number (if known)K180544
Device NameDePuy 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)Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date Prepared: July 23, 2018

| Sponsor | DePuy Synthes
Suchitra Basu, PhD, RAC
1301 Goshen Parkway
West Chester, PA 19380
Phone: +1-610-719-5448 |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | July 23, 2018 |
| Proprietary Name | DePuy Synthes Static Staples |
| Common or Usual
Name(s) | Bone Staple, Staple, Accessories |
| Classification Name | Single/multiple component metallic bone fixation appliances and accessories |
| Classification | Class II
Regulation Number: 21 CFR 888.3030
Product Code: JDR |
| Predicate Devices | Primary Predicate: Zimmer Biomet Varisation Staple (K931155)
Additional Predicates: Trilliant Surgical Sniper Staple System (K162354),
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
clearance for the DePuy Synthes Static Staples. |

4

T

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

(1) DePuy Synthes

т

| Non-clinical
Performance Data | The following analysis were conducted:
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
Performance Data | Clinical testing was not necessary for the determination of substantial equivalence. |

5

| | The Static Staples implants possess the equivalent technological
characteristics as that of the primary predicate devices (K931155). These
include:
performance, basic design, material and sizes (dimensions are comparable to those offered by the predicate systems). |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
Equivalence | The proposed device has indications for use which are fully encompassed by
the indications for use of the predicate device.
The mechanical testing and analytical evaluation included in this submission
demonstrate that:
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
summary of data submitted, it is concluded that the information provided in
this submission supports substantial equivalence. |