(26 days)
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
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.
This FDA 510(k) clearance letter is for a physical medical device (The OsteoCentric Bone Plate and Screw System), not an AI/Software as a Medical Device (SaMD). Therefore, the specific information requested in your prompt regarding AI/SaMD performance criteria, such as acceptance criteria based on accuracy, sensitivity, specificity, MRMC studies, training/test sets, and ground truth establishment, is not applicable to this document.
For traditional medical devices like the OsteoCentric Bone Plate and Screw System, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically addressed through non-clinical performance testing (e.g., mechanical testing, biocompatibility, sterilization validation) and comparison to predicate devices, rather than clinical studies involving human readers or AI algorithms.
However, I can extract the relevant information regarding the non-clinical testing and conclusions provided in the document:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a formal table of acceptance criteria with numerical targets and reported performance in the way an AI/SaMD submission would. Instead, it states:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Intermediate screw sizes do not present a new worst-case. | "Engineering analysis was performed to demonstrate that the intermediate screw sizes did not present a new worst-case..." (This implies the performance of these new sizes is within acceptable limits compared to existing sizes, likely established through mechanical testing or a justifiable engineering rationale.) |
| Clavicle plates have similar bending performance (strength and stiffness) compared to the predicates. | "...and also that the subject device clavicle plates had similar bending performance (strength and stiffness) compared to the predicates." (This implies that the measured strength and stiffness values of the new clavicle plates were within a range deemed equivalent or acceptable when compared to the established performance of the predicate devices, likely through standardized mechanical testing methods relevant to bone fixation.) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable. For mechanical testing of physical devices, "sample size" refers to the number of test articles (plates, screws) subjected to the engineering analyses. This specific number is not disclosed in the clearance letter but is part of the detailed test reports provided to the FDA.
- Data Provenance: Not applicable. The data comes from "Engineering analysis," which means laboratory testing and simulations performed on the device components themselves, not clinical data from patients or a specific country. This is in vitro data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable. Ground truth for mechanical performance is established through objective, quantifiable engineering measurements against predefined standards or predicate device performance, not expert consensus interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are relevant for subjective interpretations by multiple human readers, not for objective mechanical test results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a bone plate and screw system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this type of device's performance is based on objective engineering and mechanical properties (e.g., material strength, fatigue life, torsional rigidity, bending stiffness, screw pull-out strength). These properties are measured and evaluated against established industry standards (e.g., ASTM F138 for stainless steel, ASTM F136 for titanium) and/or comparison to predicate devices, which have a known history of safe and effective use.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI algorithm.
9. How the ground truth for the training set was established:
Not applicable. This is a physical medical device, not an AI algorithm.
In summary, the FDA 510(k) clearance for The OsteoCentric Bone Plate and Screw System relies on non-clinical engineering analysis and comparison to predicate devices to demonstrate substantial equivalence, rather than the types of performance studies typically conducted for AI/SaMD products.
FDA 510(k) Clearance Letter - OsteoCentric Bone Plate and Screw System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
March 18, 2025
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.
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K250494 - Todd Evans 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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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/device-advice-comprehensive-regulatory-
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K250494 - Todd Evans Page 3
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
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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: 07/31/2026
See PRA Statement below.
Submission Number (if known): K250494
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 non-unions 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.
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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:
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510(k) Summary
510(k) #: K250494
Prepared on: 2025-03-13
Contact Details
21 CFR 807.92(a)(1)
| Field | Value |
|---|---|
| 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)
| Field | Value |
|---|---|
| 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 clavicle plates (superior, superior lateral, anterior lateral, and anterior midshaft) and additional locking and non-locking screws (2.1 mm, 2.4mm, 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
21 CFR 807.92(a)(5)
The OsteoCentric Bone Plate and Screw is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, but not limited to periarticular, and intraarticular fractures
Indications for Use Comparison
21 CFR 807.92(a)(5)
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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 predicate. 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 clavicle 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.
§ 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.