EVOS Small Fragment Lower Extremity Plates

K170457 · Smith & Nephew, Inc. · HRS · Jun 14, 2017 · Orthopedic

Device Facts

• Record ID: K170457
• Device Name: EVOS Small Fragment Lower Extremity Plates
• Applicant: Smith & Nephew, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Jun 14, 2017
• Decision: SESE
• Submission Type: Traditional
• 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. The EVOS Partial Articular and Anti-Glide plates are indicated for the treatment of partial articular fractures of the distal and proximal tibia (AO/OTA Fracture Classification Type B), and for fracture fixation of the fibula.

Device Story

EVOS Small Fragment Lower Extremity Plates are metallic bone fixation implants designed for surgical fracture stabilization. The system includes various plate geometries featuring 2.7mm and 3.5mm holes, including threaded, non-threaded, and variable-angle locking configurations, available in 'thick' and 'thin' profiles. Used by orthopedic surgeons in clinical/OR settings, these plates provide mechanical support to bone fragments to facilitate healing. The device is implanted via standard orthopedic surgical techniques. The system shares compatible instruments and implants with existing Smith & Nephew EVOS MINI and Small Fragment systems. Clinical benefit is derived from stable internal fixation of fractures, promoting bone union and patient mobility.

Clinical Evidence

Bench testing only. Evidence includes finite element analysis (FEA) to identify worst-case designs, followed by static and cantilever bend testing to evaluate mechanical performance against predicate devices. Packaging verification testing confirmed sterility maintenance and shipping durability. Bacterial endotoxin testing confirmed compliance with ANSI/AAMI ST72 limits. No clinical data was provided.

Technological Characteristics

Metallic bone fixation plates featuring 2.7mm and 3.5mm holes (threaded, non-threaded, variable-angle locking). Available in 'thick' and 'thin' varieties. Mechanical performance validated via FEA and static/cantilever bend testing. Sterility maintained via validated packaging configurations; endotoxin levels compliant with ANSI/AAMI ST72.

Indications for Use

Indicated for adult and pediatric patients, including those with osteopenic bone, requiring fixation of small and long bone fractures (tibia, fibula, femur, humerus, ulna, radius, pelvis, acetabulum, metacarpals, metatarsals, clavicle). Partial Articular and Anti-Glide plates specifically indicated for distal/proximal tibia partial articular fractures (AO/OTA Type B) and fibula fracture fixation.

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 Bone Plate System (K993106)
• Smith & Nephew Locking Bone Plate System (K033669)
• PERI-LOC Periarticular Locked Plating System – B Plate Locking Bone Plates and Screws (K062216)
• PERI-LOC Periarticular Locked Plating System – VLP Locking Bone Plates and Screws (K071563)
• EVOS Small Fragment Plating System Straight Plates and Screws (K162078)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 14, 2017

Smith & Nephew, Inc. Samantha Staubach Regulatory Affairs Specialist 1450 Brooks Road Memphis. Tennessee 38116

Re: K170457

Trade/Device Name: EVOS Small Fragment Lower Extremity Plates 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: May 16, 2017 Received: May 17, 2017

Dear Ms. Staubach:

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

{1}------------------------------------------------

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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" (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 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.

Mark N. Melkerson-S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K170457

Device Name EVOS Small Fragment Lower Extremity Plates

#### 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.

The EVOS Partial Articular and Anti-Glide plates are indicated for the treatment of partial articular fractures of the distal and proximal tibia (AO/OTA Fracture Classification Type B), and for fracture fixation of the fibula.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">✖</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# >< We are smith&nephew

| Submitted by: | Smith & Nephew, Inc.<br>Orthopaedic Division<br>1450 East Brooks Road<br>Memphis, Tennessee 38116 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------|
| Date of Summary: | February 14, 2016 |
| | Samantha Staubach |
| | Regulatory Affairs Specialist |
| | T 901-399-6132 |
| | F 901-566-7596 |
| Name of Device: | EVOS Small Fragment Lower Extremity Plates |
| 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 Bone Plate<br>System (primary predicate,<br>now branded as TC-100) | K993106 | December 9,<br>1999 |
| Smith & Nephew, Inc. | Smith & Nephew Locking Bone<br>Plate System (now branded as<br>PERI-LOC, reference predicate) | K033669 | December 10,<br>2003 |
| Smith & Nephew, Inc. | PERI-LOC Periarticular Locked<br>Plating System – B Plate Locking<br>Bone Plates and Screws (now<br>branded as PERI-LOC VLP,<br>reference predicate) | K062216 | September 15,<br>2006 |
| Smith & Nephew, Inc. | PERI-LOC Periarticular Locked<br>Plating System – VLP Locking<br>Bone Plates and Screws | K071563 | August 8, 2007 |
| Smith & Nephew, Inc. | EVOS Small Fragment Plating<br>System Straight Plates and<br>Screws (reference predicate) | K162078 | November 18,<br>2016 |

{4}------------------------------------------------

### Device Description

Subject of this premarket notification is an extension of the EVOS Small Fragment Plating System, the EVOS Small Fragment Lower Extremity Plates. The subject plates feature similarities to existing Smith & Nephew small fragment plates (TC-100 Small Bone Plating System, PERI-LOC and PERI-LOC VLP Plating Systems, EVOS Small Fragment Plating System Straight Plates) and also share some instruments and compatible implants from the existing EVOS MINI Plating System and EVOS Small Fragment Plating System. EVOS Small Fragment Lower Extremity Plates are available in a variety of plate designs for specific anatomical areas. These plate designs include plates with 2.7mm holes or 3.5mm holes only, or with a combination of 2.7mm and 3.5mm holes. Plate designs may include threaded holes, nonthreaded holes, and variable-angle locking holes. The subject plates are offered in "thick" and "thin" varieties. The "thin" plates are the partial articular/antiglide plates.

### 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.

The EVOS Partial Articular and Anti-Glide plates are indicated for the treatment of partial articular fractures of the distal and proximal tibia (AO/OTA Fracture Classification Type B), and for fracture fixation of the fibula.

## Technological Characteristics

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. The subject devices include plates with both locking and non-locking holes, identical to the holes used in the EVOS Small Fragment Straight Plates cleared via K162078.

## Summary of Pre-Clinical Testing

- . Finite element analysis (FEA) was conducted on the proposed plate designs to determine the worst case plates for further mechanical testing. Plates were separated into groups for evaluation based upon similar designs or anatomical application.
- Bending performance was evaluated through static or cantilever bend testing for the . worst case plate designs identified through FEA. Results of the testing determined that the subject plates performed similar or superior to the predicate plates tested, when evaluated under the same conditions.
- . Packaging verification testing was conducted for the proposed packaging configurations and the results of this testing demonstrated that the product will not be damaged during shipment and will adequately maintain sterility post shipment.

{5}------------------------------------------------

- Bacterial endotoxin testing was completed and met the acceptable endotoxin limits . as stated in the FDA Guidance , "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.
#### Conclusion

This Traditional 510(k) premarket notification is being submitted to request clearance for the EVOS Small Fragment Plating System Lower Extremity Plates. 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.