(69 days)
No
The document describes a mechanical plating system for bone fractures and does not mention any AI or ML components.
Yes
The device is clearly indicated for "fixation of long bone fractures," which is a therapeutic purpose.
No
The device is described as a plating system intended for fixation of long bone fractures, which is a treatment rather than a diagnostic function.
No
The device description clearly outlines physical components like plates, screws, and cable accessories, and the performance studies include mechanical testing and MRI compatibility, indicating a 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 the "fixation of long bone fractures" in adult patients. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "Plating System" including "Plates, Blunt Tip Screws and Cable Accessories." These are physical implants used to stabilize bone fractures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not to directly treat or repair the body itself. This device falls under the category of a surgical implant for orthopedic use.
N/A
Intended Use / Indications for Use
The EVOS Large Fragment Plating System is indicated for adult patients. It is indicated for fixation of long bone fractures.
Product codes
HRS, HWC
Device Description
Subject of this premarket notification is an extension of the EVOS Large Fragment Plating System, the Peri-Prosthetic Plates, Blunt Tip Screws and Cable Accessories. The proposed devices incorporate design features similar to those currently incorporated on previously cleared Smith & Nephew bone plate and screw systems. Like their previously cleared counterparts. the proposed plates feature a screw-to-plate locking feature that permits their use with the previously cleared and compatibility designed locking and non-locking screws described in this premarket notification. EVOS Large Fragment Per-Prosthetic Plates are available in a variety of plate designs for specific anatomical areas. These plate designs have a combination of 3.5mm and 4.5mm holes. Plate designs may include threaded holes, non-threaded holes, and variable-angle locking holes. Blunt Tip Screws are available in 4.5mm diameter and are identical to the EVOS 4.5mm Cortex Locking Screws described in K201918 with the exception of the blunt tip. Cable Accessories include 3.5mm and 4.5mm cable saddles and 3.5mm cable post.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bone
Indicated Patient Age Range
adult patients
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
- 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.
- Fatigue performance was evaluated through four point bending fatigue or construct fatigue 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.
- Magnetic resonance imaging (MRI) compatibility testing was conducted as per the FDA's ● guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", December 11, 2014.
- . 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.
- . 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.
- EVOS Large Fragment Fracture Plating System Biocompatibility Testing .
Key Metrics
Not Found
Predicate Device(s)
K033669, K031162, K162078, K072818, K092015, K201918
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
January 27, 2021
Smith & Nephew, Inc. Thomas Fearnley Senior Regulatory Affairs Specialist 1450 E Brooks Road Memphis, Tennessee 38116
Re: K203405
Trade/Device Name: EVOS Large 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: November 17, 2020 Received: November 19, 2020
Dear Thomas Fearnley:
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) K203405
Device Name EVOS Large Fragment Plating System
Indications for Use (Describe)
The EVOS Large Fragment Plating System is indicated for adult patients. It is indicated for fixation of long bone fractures.
| 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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3
We are smith&nephew
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------|
| Date of Summary: | November 17, 2020 |
| Name of Device: | EVOS Large Fragment Plating System Peri-Prosthetic |
| Common Name: | Bone Plates |
| Device Classification Name and
Reference: | 21 CFR 888.3030 Single/multiple component metallic bone
fixation appliances and accessories |
| | 21 CFR 888.3040 Smooth or threaded metallic bone fixation
fastener |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
Predicates
Product Code:
| Manufacturer | Description | Submission
Number | Clearance Date |
|-------------------------|--------------------------------------------------------------------------------------|----------------------|----------------------|
| Smith & Nephew,
Inc. | Smith & Nephew Locking Bone
Plate System (PERI-LOC) Primary
Predicate | K033669 | December 10,
2003 |
| Smith & Nephew, Inc. | Smith & Nephew Orthopaedic
Cabling System (ACCORD) | K031162 | May 1, 2003 |
| Smith & Nephew, Inc. | EVOS Small Fragment Plating
System Straight Plates and Screws | K162078 | November 18, 2016 |
| Smith & Nephew, Inc. | PERI-LOC Proximal Femur Locking
Bone Plates, Bone Screws and
Cable Accessories | K072818 | November 19, 2007 |
| Smith & Nephew, Inc. | PERI-LOC Periarticular Locked
Plating System for Lower & Upper
Extremity | K092015 | July 30, 2009 |
| Smith & Nephew, Inc. | EVOS Large Fragment Plating
System | K201918 | November 16,
2020 |
HRS, HWC
4
Device Description
Subject of this premarket notification is an extension of the EVOS Large Fragment Plating System, the Peri-Prosthetic Plates, Blunt Tip Screws and Cable Accessories. The proposed devices incorporate design features similar to those currently incorporated on previously cleared Smith & Nephew bone plate and screw systems. Like their previously cleared counterparts. the proposed plates feature a screw-to-plate locking feature that permits their use with the previously cleared and compatibility designed locking and non-locking screws described in this premarket notification. EVOS Large Fragment Per-Prosthetic Plates are available in a variety of plate designs for specific anatomical areas. These plate designs have a combination of 3.5mm and 4.5mm holes. Plate designs may include threaded holes, non-threaded holes, and variable-angle locking holes. Blunt Tip Screws are available in 4.5mm diameter and are identical to the EVOS 4.5mm Cortex Locking Screws described in K201918 with the exception of the blunt tip. Cable Accessories include 3.5mm and 4.5mm cable saddles and 3.5mm cable post.
Indications for Use
The EVOS Large Fragment Plating System is indicated for adult patients. It is indicated for fixation of long bone fractures.
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. Locking holes in the plates can either be threaded holes or variable angle holes and non-locking holes are not threaded. The holes are identical to those used in the EVOS Large Fragment Plates cleared via K201918. The subject screws feature a hex drive and are identical to existing Smith & Nephew predicate screws with respect to threadform and major and minor diameter.
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.
- Fatigue performance was evaluated through four point bending fatigue or construct fatigue 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.
- Magnetic resonance imaging (MRI) compatibility testing was conducted as per the FDA's ● guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", December 11, 2014.
- . 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.
- . 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.
- EVOS Large Fragment Fracture Plating System Biocompatibility Testing .
5
Conclusion
This Traditional 510(k) premarket notification is being submitted to request clearance for the EVOS Large Fracture Plating System Peri-Prosthetic. 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.