EVOS Small Fragment Upper Extremity Plates Line Additions

K190253 · Smith & Nephew, Inc. · HRS · Mar 11, 2019 · Orthopedic

Device Facts

• Record ID: K190253
• Device Name: EVOS Small Fragment Upper Extremity Plates Line Additions
• Applicant: Smith & Nephew, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Mar 11, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The EVOS Small Fragment Plating System is indicated for adult and pediatric patients with osteopenic bone. It is indicated for fixation of small and long bone fractures, including, but not limited to, those of the tibia, fibula, femur, humerus, ulna, radius, pelvis, acetabulum, metacarpals, metatarsals, and clavicle.

Device Story

EVOS Small Fragment Upper Extremity Plates are metallic bone fixation implants; line additions to existing system (K173293). Devices feature modifications to plate shape and hole count; designed for use with previously cleared Smith & Nephew bone screws and instruments. Used by orthopedic surgeons in clinical settings for fracture fixation. Output is physical stabilization of bone fragments; aids in healing of small and long bone fractures. Benefits include structural support for osteopenic and standard bone tissue.

Clinical Evidence

Bench testing only. Finite element analysis (FEA) was performed to evaluate peak stress of design modifications to plate geometry.

Technological Characteristics

Metallic bone fixation plates; design modifications to shape and hole count. Compatible with existing Smith & Nephew bone screws and instrumentation. Evaluated via finite element analysis (FEA).

Indications for Use

Indicated for adult and pediatric patients, including those with osteopenic bone, requiring fixation of small and long bone fractures (e.g., tibia, fibula, femur, humerus, ulna, radius, pelvis, acetabulum, metacarpals, metatarsals, clavicle).

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

• Smith & Nephew EVOS Small Fragment Upper Extremity Plates (K173293)

Submission Summary (Full Text)

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March 11, 2019

Image /page/0/Picture/1 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Smith & Nephew, Inc. Shereen Bienz Senior Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116

### Re: K190253

Trade/Device Name: EVOS Small Fragment Upper Extremity Plates Line Additions 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: February 6, 2019 Received: February 7, 2019

## Dear Shereen Bienz:

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.

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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,

# Shumaya Ali -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) K190253

Device Name

EVOS Small Fragment Upper Extremity Plates Line Additions

### Indications for Use (Describe)

The EVOS Small Fragment Plating System is indicated for adult and pediatric patients with osteopenic bone. It is indicated for fixation of small and long bone fractures, including, but not limited to, those of the tibia, fibula, femur, humerus, ulna, radius, pelvis, acetabulum, metacarpals, metatarsals, and clavicle.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# le are smith&nephew

| Submitted by: | Smith & Nephew, Inc.<br>Orthopaedic Division<br>1450 East Brooks Road<br>Memphis, Tennessee 38116 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------|
| Date of Summary: | February 6, 2019 |
| Name of Device: | EVOS Small Fragment Upper Extremity Plates Line Additions |
| Common Name: | Bone Plates |
| Device Classification Name and<br>Reference: | 21 CFR 888.3030 Single/multiple component metallic bone<br>fixation appliances and accessories |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | HRS |

### Predicates

| Manufacturer | Description | Submission<br>Number | Clearance Date |
|----------------------|--------------------------------------------------------------|----------------------|-----------------|
| Smith & Nephew, Inc. | Smith & Nephew EVOS Small<br>Fragment Upper Extremity Plates | K173293 | January 8, 2018 |

### Device Description

Subject of this premarket notification are line additions to the EVOS Small Fragment Upper Extremity Plating System. The line additions are design modifications of existing plates cleared in K173293 and include changes to the shape and number of holes of the subject plates. When compared against the existing EVOS Small Fragment Plates already cleared for market, the subject plates use the same hole features and are designed to work with the same bone screws.

The subject EVOS Small Fragment Upper Extremity plates are intended to be used with existing Smith & Nephew implants and instruments that have been previously cleared for market for use with the EVOS Small Fragment Plating System.

### Indications for Use

The EVOS Small Fragment Plating System is indicated for adult and pediatric patients, as well as patients with osteopenic bone. It is indicated for fixation of small and long bone fractures, including, but not limited to, those of the tibia, fibula, femur, humerus, ulna, radius, pelvis, acetabulum, metacarpals, metatarsals, and clavicle.

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### Technological Characteristics

The subject devices are similar to existing Smith & Nephew Upper Extremity plates cleared in K173293. The minor modifications to the shape of the plate and number of holes are not expected to impact device safety or effectiveness, as demonstrated through mechanical testing. Device comparisons described in this premarket notification demonstrated that the proposed devices are substantially equivalent to legally marketed predicates with respect to intended use, indications, and performance characteristics.

### Summary of Pre-Clinical Testing

- . Finite element analysis (FEA) was conducted on the proposed plate designs to evaluate the peak stress of potential design modifications to the subject plates
### Conclusion

This Special 510(k) premarket notification is being submitted to request clearance for the EVOS Small Fragment Plating System Upper Extremity Plates modifications. Based on similarities to the predicate plating systems and a review of the mechanical testing performed, the subject devices are substantially equivalent to the predicate devices.