EVOS Small Fragment Plating System

K172262 · Smith & Nephew, Inc. · HRS · Aug 23, 2017 · Orthopedic

Device Facts

• Record ID: K172262
• Device Name: EVOS Small Fragment Plating System
• Applicant: Smith & Nephew, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Aug 23, 2017
• 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, acctabulum, metacarpals, metatarsals, and clavicle.

Device Story

EVOS Small Fragment Plating System consists of metallic bone screws used for fracture fixation. Subject device introduces minor design modifications to previously cleared 3.5mm non-locking cortex screws and 4.7mm non-locking osteopenia screws (K162078). Modifications include updated screw tip geometry and increased screw head diameter. Screws are intended for use with existing Smith & Nephew implants and instruments. Device is used by orthopedic surgeons in clinical settings to stabilize bone fractures. Output is mechanical fixation of bone segments, facilitating healing. Benefits include improved stripping torque performance compared to predicate design.

Clinical Evidence

Bench testing only. Testing included screw insertion testing and maximum stripping torque testing. Results demonstrated modified screws performed similar or superior to existing EVOS design and met acceptance criteria for stripping torque. Pyrogen testing relied on existing data from K162078 and worst-case feature analysis.

Technological Characteristics

Metallic bone screws (cortex and osteopenia). Modifications: updated tip geometry and increased head diameter. Materials, manufacturing methods, sterility, and packaging are identical to predicate K162078. No software or electronic components.

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, Inc. EVOS Small Fragment Plating System (K162078)

Submission Summary (Full Text)

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

August 23, 2017

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

Re: K172262

Trade/Device Name: EVOS Small Fragment Plating 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, HWC Dated: July 26, 2017 Received: July 27, 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

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Part 807); labeling (21 CFR Part 801); medical device 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 (DICE) 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely, Katherine D. Kavlock

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for 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 Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

## K172262

Device Name EVOS Small Fragment Plating System

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, acctabulum, metacarpals, metatarsals, and clavicle.

| | | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------- |
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| 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)

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Image /page/3/Picture/1 description: The image contains the Smith & Nephew logo. The logo features a stylized orange flower-like symbol on the left. To the right of the symbol, the text "We are smith&nephew" is displayed, with "We are" in gray and "smith&nephew" in orange.

| Submitted by: | Smith & Nephew, Inc.<br>Orthopaedic Division<br>1450 East Brooks Road<br>Memphis, Tennessee 38116 |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | August 18, 2017<br>Samantha Staubach<br>Regulatory Affairs Specialist<br>T 901-399-6132<br>F 901-566-7596 |
| Name of Device: | EVOS Small Fragment Plating System |
| Common Name: | Bone Screws |
| Device Classification Name and<br>Reference: | 21CFR 888.3030 Single/multiple component metallic bone<br>fixation appliances and accessories<br>21 CFR 888.3040 Smooth or threaded metallic bone fixation<br>fastener |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | HRS/HWC |

#### Predicates

| Manufacturer | Description | Submission<br>Number | Clearance Date |
|----------------------|------------------------------------------------------------|----------------------|----------------------|
| Smith & Nephew, Inc. | Smith & Nephew, Inc. EVOS<br>Small Fragment Plating System | K162078 | November 18,<br>2016 |

### Device Description

The subject of this special premarket notification are minor modifications to the 3.5mm nonlocking cortex screws and 4.7mm non-locking osteopenia screws (fully and partially threaded) previously cleared for market via Traditional 510(k), K162078. Design modifications described in this submission include minor updates to the tip of the cortex screw design and an increase in the screw head diameter for both the cortex and osteopenia screws.

The subject EVOS Small Fragment non-locking screws 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 very similar to existing Smith & Nephew Plating System 3.5mm nonlocking cortex screws and 4.7mm non-locking osteopenia screws cleared via K162078. The minor modifications to the tip of the cortex screw and the head of the cortex and osteopenia screws 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 identical to the predicate EVOS Small Fragment Plating System non-locking screws with respect to intended use, indications, materials, methods of manufacture, sterility, and packaging.

## Summary of Pre-Clinical Testing

- Screw insertion testing Insertion testing was conducted for the cortex screws with . modified tips and was compared to the existing EVOS design. Results of the testing demonstrated that screws manufactured with the modified tip performed similar or superior to the existing EVOS screw design.
- Maximum stripping torque testing EVOS screws with modified screw head . diameters were compared against the existing EVOS screw design. Results of the testing demonstrated that the proposed head design modification met the acceptance criteria in that they were significantly different compared to the current EVOS screw design (increase in maximum stripping torque).
- Engineering rationale Pyrogen testing was previously conducted for EVOS screws to ● support clearance of K162078. Existing results for the EVOS implants, as well as other implants cleaned using the same cleaning system that are considered more worstcase in terms of features, were reviewed and it was determined that the subject devices do not represent a new worst-case device.

## Conclusion

This Special 510(k) premarket notification is being submitted to request clearance for the modified non-locking screws intended to be used with the EVOS Small Fragment Plating System. Based on similarities to the predicate components and a review of the mechanical testing performed, the subject modified screws are substantially equivalent to the predicate screws cleared via K162078.