The OsteoCentric® Unifi MI® TCS Plating System 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.

Device Description

The OsteoCentric® UnifiMI® TCS Plating System consists of implants and instruments designed for fixation to treat fractures, deformations, revisions and replantations of bone and bone fragments. The purpose of the submission is for a line extension of the OsteoCentric Bone Plate and Screw System, which includes 2.7mm angle iron plates, additional screw sizes, and the inclusion of titanium as a material. The principal benefit of the proposed 2.7mm angle iron new plate geometry is that it allows for a stronger and more stable plate in a smaller form factor. Having a stronger and more stable plate in a smaller form factor has the potential clinical benefits of aiding the user in minimizing the incision required for the procedure and providing an option to the surgeon user that allows for the same strength and stability as a much larger plate, without having to disrupt as much soft tissue. This line extension has the same Indications for Use as the original system. This Line Extension will be known as the OsteoCentric® UnifiMI® TCS Plating System. The system features angle plates and bone screws for fixation that are locking or non-locking, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from 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.

AI/ML Overview

This 510(k) clearance letter for the OsteoCentric® UnifiMI® TCS Plating System describes an orthopedic plating system, not an AI/software device. Therefore, the information typically found in a study proving acceptance criteria for an AI-based medical device (such as those involving performance metrics like sensitivity, specificity, or AUC, and details about training/test sets, expert ground truth, and reader studies) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices for a physical medical device (bone plates and screws) by assessing its mechanical performance.

Here's a breakdown based on the provided document, addressing the closest applicable points:

1. A table of acceptance criteria and the reported device performance:

The document broadly states: "Engineering analysis was performed to demonstrate that the new bone plates and screws did not present a new worst-case. The data demonstrates that the subject device is substantially equivalent to the predicates."

While specific quantitative acceptance criteria and their corresponding reported performance values are not explicitly laid out in a table in this summary, the implicit acceptance criterion is:

Acceptance Criterion: The mechanical strength and stability of the new 2.7mm angle iron plates and additional screw sizes must be equivalent to or better than the predicate devices, and not present a "new worst-case" scenario.
Reported Device Performance: The data demonstrates substantial equivalence to the predicates in terms of mechanical strength and stability.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated in the public summary document. For mechanical testing of physical devices, this typically refers to the number of individual plates/screws tested.
Data Provenance: Not applicable in the context of data acquisition for AI/software. The "data" here refers to the results of mechanical engineering tests (e.g., fatigue testing, static testing) performed on the physical devices. This testing would be done in a lab setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as this is a physical device clearance based on engineering testing, not clinical data requiring expert review for ground truth. The "ground truth" here is established by standardized mechanical testing methodologies (e.g., ASTM standards) and engineering principles.

4. Adjudication method for the test set:

Not applicable. Mechanical test results are objective measurements (e.g., force, displacement), not subjective interpretations requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

No. This is a physical device, and MRMC studies are relevant for software/AI devices where human readers' performance with and without AI assistance is evaluated.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm.

7. The type of ground truth used:

The "ground truth" for demonstrating substantial equivalence for this physical device is based on engineering analysis and standardized mechanical testing results. The performance of the subject device (strength, stability) is compared against the known performance characteristics of the predicate devices, likely derived from similar benchtop testing or regulatory submissions.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not applicable. No training set is involved.

Summary specific to this device type (physical orthopedic implant):

The "acceptance criteria" for this type of device primarily revolve around mechanical performance and material biocompatibility to ensure it is as safe and effective as existing legally marketed predicate devices. The study proving this involves:

Non-Clinical Testing: "Engineering analysis was performed to demonstrate that the new bone plates and screws did not present a new worst-case." This would typically include:
- Mechanical Testing: Such as static compression/tension/torsion tests, fatigue testing, push-out/pull-out tests for screw fixation. These tests are often conducted according to relevant ASTM or ISO standards for bone plates and screws.
- Material Characterization: Ensuring the Titanium and Stainless Steel meet medical-grade specifications (ASTM F136, ASTM F138).
Comparison to Predicates: The test results are then compared to the performance envelopes of the predicate devices. The "acceptance" is achieved if the new device's performance falls within an acceptable range, demonstrating it is "substantially equivalent" and does not introduce new safety or effectiveness concerns due to its mechanical properties or new geometry.

The document implicitly states that the acceptance criterion was met as the data demonstrated substantial equivalence to the predicates, particularly in showing that the "new bone plates and screws did not present a new worst-case."

Summary

FDA 510(k) Clearance Letter - OsteoCentric® UnifiMI® TCS Plating System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

August 16, 2025

OsteoCentric Technologies
Todd Evans
Vice President of Quality & Regulatory Affairs
75 West 300 North
Suite 150
Logan, Utah 84321

Re: K251913
Trade/Device Name: OsteoCentric® UnifiMI® TCS 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: August 5, 2025
Received: August 7, 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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K251913 - 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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K251913 - 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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Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. K251913

Please provide the device trade name(s).
OsteoCentric® UnifiMI® TCS Plating System

Please provide your Indications for Use below.
The OsteoCentric® Unifi MI® TCS Plating System 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.

Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

OsteoCentric® UnifiMI® TCS Plating System K251913 Page 1 of 1

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510(k) Summary

510(k) #: K251913
Prepared on: 2025-08-06

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	OsteoCentric® UnifiMI® TCS Plating 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

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
K140814	EVOS MINI-FRAGMENT PLATING SYSTEM	HRS
K250494	OsteoCentric Bone Plate and Screw System	HRS

Device Description Summary

21 CFR 807.92(a)(4)

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

The OsteoCentric® Unifi MI® TCS Plating System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula,

K251913 Page 1 of 2

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K251913 Page 2 of 2

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)

The indications are similar to the primary predicate device.

Technological Comparison

21 CFR 807.92(a)(6)

The subject device is similar in technological characteristics to the predicate devices. The principal benefit of the proposed 2.7mm angle iron plate geometry is that it allows for a stronger and more stable plate in a smaller form factor. Having a stronger and more stable plate in a smaller form factor has the potential clinical benefits of aiding the user in minimizing the incision required for the procedure and providing an option to the surgeon user that allows for the same strength and stability as a much larger plate, without having to disrupt as much soft tissue. The principle of operation and product code is identical between the subject and predicate devices. The indications for use, material, mechanical strength, sterility, bone plate sizes, and screw sizes are equivalent between the subject and predicate devices. See the Verification and Validation Section for more details.

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

Engineering analysis was performed to demonstrate that the new bone plates and screws did not present a new worst-case. The data demonstrates that the subject device is substantially equivalent to the predicates.

K251913 Page 2 of 2

Regulation Number and Section

§ 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.