DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)

K211051 · DePuy Synthes · HRS · Jun 2, 2021 · Orthopedic

Device Facts

• Record ID: K211051
• Device Name: DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)
• Applicant: DePuy Synthes
• Product Code: HRS · Orthopedic
• Decision Date: Jun 2, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy Synthes 2.7 mm LCP Plates (Modular Mini Fragment LCP System) is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle.

Device Story

System consists of metallic plates and screws for bone fixation; merges locking screw technology with conventional AO plating techniques. Locking screws create fixed-angle constructs; provides improved fixation in osteopenic bone or multifragment fractures where traditional screw purchase is compromised. Used by surgeons in clinical settings for orthopedic trauma and reconstruction. Plates available in various sizes, stainless steel, and commercially pure titanium. Device provides mechanical stability to bone fragments to facilitate healing.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical performance evaluation, including mechanical testing, MR compatibility evaluation, endotoxin testing (LAL method), and biocompatibility testing per ISO 10993-1.

Technological Characteristics

Materials: stainless steel and commercially pure titanium. Principle: locking compression plate (LCP) system using fixed-angle constructs. Configuration: various sizes, sterile. Biocompatibility: ISO 10993-1 compliant. Endotoxin limit: 20EU/device.

Indications for Use

Indicated for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone, including hand, wrist, foot, and ankle.

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

• Synthes (USA) Modular Mini Fragment LCP System (K063049)

Reference Devices

• Stryker VariAx 2 Distal Radius Plating System (K141430)
• Stryker VariAx 2 Compression Plating System (K170727)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 2, 2021

DePuy Synthes Ann-Christin Ponick Senior Regulatory Affairs Specialist Luzernstrasse 21 Zuchwil, Solotburn 4528 Switzerland

Re: K211051

Trade/Device Name: DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: April 1, 2021 Received: April 8, 2021

Dear Ann-Christin Ponick:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K211051

Device Name

DePuy Synthes 2.7 mm LCP Plates (Modular Mini Fragment LCP System)

Indications for Use (Describe)

The DePuy Synthes 2.7 mm LCP Plates (Modular Mini Fragment LCP System) is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg class="bi bi-check-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> <path d="M10.97 4.97a.75.75 0 0 1 1.071 1.05l-3.992 4.99a.75.75 0 0 1-1.08.02L4.324 8.384a.75.75 0 1 1 1.06-1.06l2.094 2.093 3.473-4.425a.236.236 0 0 1 .02-.022z" fill-rule="evenodd"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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K211051

| Sponsor | DePuy Synthes<br>1301 Goshen Parkway<br>West Chester, PA, 19380 | | |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|--|
| | Primary Contact: | Alternate Contact: | |
| | Ann-Christin Ponick | Stacey Bonnell | |
| | Senior Regulatory Affairs Specialist | Director, Regulatory Affairs | |
| | DePuy Synthes | DePuy Synthes | |
| | Luzernstrasse 21 | 1301 Goshen Parkway | |
| | 4528 Zuchil, Switzerland | West Chester, PA, 19380 | |
| | Phone: [phone] | Phone: (484) 238 —7519 | |
| | E-Mail: [e-mail] | E-Mail: [e-mail] | |
| Date<br>Prepared | May 26, 2021 | | |
| Proprietary<br>Name | DePuy Synthes 2.7 mm LCP Plates<br>(Modular Mini Fragment LCP System) | | |
| Classification<br>Name | Single/multiple component metallic bone fixation appliances and accessories | | |
| Classification | Class II<br>Regulation Number: 21 CFR 888.3030<br>Product Code: HRS | | |
| Predicate<br>device | Synthes (USA) Modular Mini Fragment LCP System (K063049) | | |
| Reference<br>Device A | Stryker VariAx 2 Distal Radius Plating System (K141430) | | |
| Reference<br>Device B | Stryker VariAx 2 Compression Plating System (K170727) | | |
| Device<br>Description | The Synthes Modular Mini Fragment LCP (Locking Compression Plate) System consists<br>of metallic plates and screws that merge locking screw technology with conventional<br>plating techniques. Locking screws provide the ability to create a fixed-angle construct<br>while utilizing familiar AO plating techniques. A fixed-angle construct provides improved<br>fixation in osteopenic bone or multifragment fractures where traditional screw purchase is<br>compromised. | | |

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## K211051

| | The subject plates are available in various sizes in sterile configurations and are<br>available in stainless steel and commercially pure titanium.<br>The system also consists of implantable screws (K112583) that correspond to the subject<br>device. |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for use | The DePuy Synthes 2.7 mm LCP Plates (Modular Mini Fragment LCP System) is<br>intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of<br>small bones and small bone fragments, particularly in osteopenic bone. Examples<br>include, but are not limited to, the hand, wrist, foot, and ankle. |
| Non-clinical<br>Performance<br>Data | The non-clinical performance evaluation of the DePuy Synthes, 2.7mm LCP Plates per<br>this submission has been compared to the existing DePuy Synthes, 2.7mm LCP plates<br>with regards to mechanical performance. The evaluation supports that the mechanical<br>performance of the subject devices are at least equivalent to that of the predicate<br>devices.<br><br>Magnetic Resonance compatibility evaluation has been performed to establish the MR<br>Conditional parameters for the subject DePuy Synthes, 2.7mm LCP Plates.<br><br>Endotoxin testing has been performed using to the LAL test method to establish that the<br>subject DePuy Synthes 2.7mm LCP Plates meet the specified endotoxin requirement of<br>20EU/device.<br><br>Biocompatibility evaluation and testing has been performed in accordance with ISO<br>10993-1 and it is concluded that the subject DePuy Synthes 2.7mm LCP Plates are<br>biologically safe when used as intended. |
| Clinical<br>Performance<br>Data | Clinical testing was not necessary for the determination of substantial equivalence. |
| Substantial<br>Equivalence | The subject devices fully align with the indications for use compared to the predicate,<br>Synthes (USA) Modular Mini Fragment LCP System (K063049).<br><br>A comparison of the subject devices DePuy Synthes 2.7mm Straight and 2.7mm<br>Adaption Plates (Modular Mini Fragment LCP System) demonstrated that they are<br>substantially equivalent to the previously cleared Synthes (USA) Modular Mini Fragment<br>LCP System (K063049), VariAx 2 Distal Radius Plating System (K141430) and the<br>VariAx 2 Compression Plating System (K170727) from Stryker in regards to intended<br>use, material, design, and operational principles.<br><br>The non-clinical performance data as well as the comparison of design features included<br>in this premarket notification demonstrate that any differences in technological<br>characteristics of the subject devices compared to the predicate devices do not raise any<br>new questions of safety and effectiveness.<br>It is concluded that the information provided herein supports substantial equivalence of<br>the subject devices. |