(26 days)
Not Found
No
The summary describes a mechanical bone plate and screw system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a bone plate and screw system intended for fixation of fractures, osteotomies, and nonunions, which falls under surgical hardware for mechanical support rather than therapeutic treatment of a disease or condition.
No
Explanation: The device is described as a bone plate and screw system intended for fixation of fractures, osteotomies, and nonunions, which means it is a treatment device, not a diagnostic one.
No
The device description clearly states it is a bone plate and screw system fabricated from stainless steel or titanium, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that this device is a "Bone Plate and Screw" system intended for the "fixation of fractures, osteotomies, and nonunions." This is a surgical implant used directly on the body, not for testing specimens outside the body.
- Intended Use: The intended use is for surgical fixation of bones, which is a therapeutic procedure, not a diagnostic test.
The information provided describes a surgical implant, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The OsteoCentric Bone Plate and Screw is intended for fixation of fractures, osteotomies, and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, but not limited to periarticular, and intraarticular fractures
Product codes
HRS, HWC, HTY
Device Description
The subject system is a line extension that includes clavices (superior lateral, anterior mideral, and anterior midshaft) and additional locking and non-locking screws (2.1mm, and 2.7mm diameter). The plates and screws are fabricated from either medical grade stainless steel per ASTM F138 or Titanium per ASTM F136. Plates and screws are provided non-sterile. Instruments are provided non-sterile with instructions for sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula
Indicated Patient Age Range
Not Found
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
Engineering analysis was performed to demonstrate that the intermediate screw sizes did not present a new worst-case and also that the subject device clavice plates had similar bending performance (strength and stiffness) compared to the predicates. The data demonstrates that the subject device is substantially equivalent to the predicates.
Key Metrics
Not Found
Predicate Device(s)
K190430, K152000, K210192, K150981, K112583
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
March 18, 2025
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a larger font size than the words "U.S. FOOD & DRUG ADMINISTRATION" below it.
OsteoCentric Technologies Todd Evans Vice President of Quality & Regulatory Affairs 75 West 300 North Suite 150 Logan, Utah 84321
Re: K250494
Trade/Device Name: The OsteoCentric Bone Plate and Screw 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, HTY Dated: February 19, 2025 Received: February 20, 2025
Dear Todd Evans:
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.
1
Page
2
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" (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 QS 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 Rule"). 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-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-device-advice-comprehensive-regulatory
2
assistance/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,
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
The OsteoCentric Bone Plate and Screw System
Indications for Use (Describe)
The OsteoCentric Bone Plate and Screw is intended for fixation of fractures, osteotomies, and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, but not limited to periarticular, and intraarticular fractures
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)
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."
4
| 510(k) #: K250494 | 510(k) Summary | Prepared on: 2025-03-13 |
|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |
| Applicant Name | OsteoCentric Technologies | |
| Applicant Address | 75 West 300 North Suite 150 Logan UT 84321 United States | |
| Applicant Contact Telephone | 435-757-2253 | |
| Applicant Contact | Mr. Todd Evans | |
| Applicant Contact Email | todd.evans@osteocentric.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | The OsteoCentric Bone Plate and Screw 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, HTY | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K190430 | OsteoCentric Bone Plate and Screw System | HRS |
| K152000 | SMV Scientific Bone Plate and Screw System | HRS |
| K210192 | A.L.P.S. Clavicle Plating System | HRS |
| K150981 | SMV Scientific Bone Screws | HWC |
| K112583 | Synthes Cortical Screws | HWC |
| Device Description Summary | 21 CFR 807.92(a)(4) |
The subject system is a line extension that includes clavices (superior lateral, anterior mideral, and anterior midshaft) and additional locking and non-locking screws (2.1mm, and 2.7mm diameter). The plates and screws are fabricated from either medical grade stainless steel per ASTM F138 or Titanium per ASTM F136. Plates and screws are provided non-sterile. Instruments are provided non-sterile with instructions for sterilization.
Intended Use/Indications for Use
The OsteoCentric Bone Plate and Screw is intended for fixation of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, but not limited to periarticular fractures
Indications for Use Comparison
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
5
The indications are the same as the predicate device.
Technological Comparison
21 CFR 807.92(a)(6)
The new screw sizes fall within the size range of the subject plates differ because their shape is anatomically specific to the clavicle.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Engineering analysis was performed to demonstrate that the intermediate screw sizes did not present a new worst-case and also that the subject device clavice plates had similar bending performance (strength and stiffness) compared to the predicates. The data demonstrates that the subject device is substantially equivalent to the predicates.