(254 days)
Not Found
No
The device description and performance studies focus on mechanical properties and material compatibility, with no mention of AI or ML.
Yes.
The device is used for the "fixation of fractures and/or disruptions of the pelvis and acetabulum," which is a therapeutic function.
No
The device is described as an EVOS Pelvic and Acetabular System, which consists of bone plates and screws indicated for fixation of fractures and disruptions of the pelvis and acetabulum. This is a treatment device, not a diagnostic one.
No
The device description explicitly states it consists of "Class II bone plate and screw implants" made from "implant-grade 316L Stainless Steel material," which are physical hardware components.
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 fractures and/or disruptions of the pelvis and acetabulum." This describes a surgical implant used to stabilize bones.
- Device Description: The device is described as "Class II bone plate and screw implants." These are physical devices implanted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The EVOS Pelvic and Acetabular System is indicated for fixation of fractures and/or disruptions of the pelvis and acetabulum in skeletally mature patients.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC, HTN
Device Description
The subject EVOS Pelvic and Acetabular System consists of Class II bone plate and screw implants. The subject bone plates are available in a variety of shapes and sizes. The subject screws consist of locking screws as well as cannulated screws. The subject plates are also compatible with the previously cleared EVOS locking screws, and partially and fully threaded osteopenia screws (K140814 S.E. 5/7/2014 and K162078 S.E. 7/27/2016). The proposed plates and screws are manufactured from implant-grade 316L Stainless Steel material and will be available in a sterile packaged condition.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvis and acetabulum
Indicated Patient Age Range
skeletally mature 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following nonclinical tests were used to determine substantial equivalence:
- Finite element analysis (FEA) was conducted on the subject plates to determine worst case plate for mechanical testing.
- Four Point Bend Fatique testing of the subject plates per ASTM F382.
- Static Evaluation of the screws per ASTM F543.
- Bending Fatigue testing of the screws per ASTM F1264.
- Magnetic resonance imaging (MR) compatibility evaluation was done per ASTM F2213, ASTM F2182, and ASTM F2119.
- Packaging verification testing was conducted on the subject devices per ASTM F2096 and ASTM F88.
No clinical testing was performed on the subject devices.
The testing detailed in this premarket notification confirms that the subject EVOS Pelvic and Acetabular Plating system is substantially equivalent in performance to the predicate EVOS Plating Systems (K162078, S.E. 11/18/2016 and K140814, S.E. 5/7/2014).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K162078, K140814, K060736, K170887, K173293, K122538, K063166, K210935, K221809, K993106
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
February 19, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and boldest, followed by "U.S. FOOD & DRUG" and then "ADMINISTRATION".
Smith & Nephew Mandy Coe Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116
Re: K241666
Trade/Device Name: EVOS Pelvic and Acetabular 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. HTN Dated: January 22, 2025 Received: January 22, 2025
Dear Mandy Coe:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for
2
more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CHRISTOPHER FERREIRA -S
Christopher Ferreira, M.S. 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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
EVOS Pelvic and Acetabular System
Indications for Use (Describe)
The EVOS Pelvic and Acetabular System is indicated for fixation of fractures and/or disruptions of the pelvis and acetabulum in skeletally mature patients.
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
| 510(k) #: | K241666 | 510(k) Summary | Prepared on: 2025-01-21 |
|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | ||
| Applicant Name | Smith & Nephew | ||
| Applicant Address | 1450 Brooks Road Memphis TN 38116 United States | ||
| Applicant Contact Telephone | 901-949-3344 | ||
| Applicant Contact | Mrs. Mandy Coe | ||
| Applicant Contact Email | mandy.coe@smith-nephew.com | ||
| Device Name | 21 CFR 807.92(a)(2) | ||
| Device Trade Name | EVOS Pelvic and Acetabular System | ||
| Common Name | Single/multiple component metallic bone fixation appliances and accessories | ||
| Classification Name | Plate, Fixation, Bone | ||
| Regulation Number | 888.3030 | ||
| Product Code(s) | HRS, HWC, HTN | ||
| Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) | |||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| K162078 | EVOS Small-Fragment Plating System | HRS | |
| K140814 | EVOS Mini-Fragment Plating System | HRS | |
| K060736 | Smith & Nephew 6.5mm and 8.0mm Cannulated Screws | HWC | |
| K170887 | EVOS Small Fragment Plating System | HRS | |
| K173293 | EVOS Small Fragment Upper Extremity Plates | HRS | |
| K122538 | Acumed Pelvic Bone Plate System | HRS | |
| K063166 | ITS Pelvic Reconstruction System | HRS | |
| K210935 | ITS Pelvic Reconstruction System (PRS RX & Phoenix) | HRS | |
| K221809 | DePuy Synthes 3.5mm Intrapelvic Acetabular System | HRS | |
| K993106 | Smith & Nephew Bone Plate System | HRS | |
| Device Description Summary 21 CFR 807.92(a)(4) |
5
The subject EVOS Pelvic and Acetabular System consists of Class Il bone plate and screw implants. The subject bone plates are available in a variety of shapes and sizes. The subject screws consist of locking screws as well as cannulated screws. The subject plates are also compatible with the previously cleared EVOS locking screws, and partially and fully threaded osteopenia screws (K140814 S.E. 5/7/2014 and K162078 S.E. 7/27/2016). The proposed plates and screws are manufactured from implant-grade 316L Stainless Steel material and will be available in a sterile packaged condition.
Intended Use/Indications for Use
The EVOS Pelvic and Acetabular System is indicated for fixation of fractures and/or disruptions of the pelvis and acetabuly mature patients.
Indications for Use Comparison
The indications for use of the subject devices are substantially equivalent to the indications for the cleared predicates.
Technological Comparison
Device comparisons described in this premarket notification demonstrated that the proposed bone plates and screws are substantially equivalent to legally marketed predicates with respect to intended use, indications, and performance characteristics. Both the subject and predicate devices have same operating principle, material, and technological characteristics.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following nonclinical tests were used to determine substantial equivalence:
- · Finite element analysis (FEA) was conducted on the subject plates to determine worst case plate for mechanical testing.
- · Four Point Bend Fatique testing of the subject plates per ASTM F382.
- · Static Evaluation of the screws per ASTM F543.
- · Bending Fatigue testing of the screws per ASTM F1264.
- · Magnetic resonance imaging (MR) compatibility evaluation was done per ASTM F2213, ASTM F2182, and ASTM F2119.
- · Packaging verification testing was conducted on the subject devices per ASTM F2096 and ASTM F88.
No clinical testing was performed on the subject devices.
The testing detailed in this premarket notification confirms that the subject EVOS Pelvic and Acetabular Plating system is substantially equivalent in performance to the predicate EVOS Plating Systems (K162078, S.E. 11/18/2016 and K140814, S.E. 5/7/2014),
21 CFR 807.92(a)(5)
21 CFR 807 92(a)(6)
21 CFR 807.92(a)(5)