(27 days)
Not Found
No
The device description and performance studies focus solely on the mechanical properties and materials of the bone plates and screws. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is indicated for "fixation of fractures, mal-unions, non-unions or osteotomies," which are conditions that it is designed to treat or alleviate, fitting the definition of a therapeutic device.
No
The device is described as a system of plates, screws, and instruments for the fixation of fractures, mal-unions, non-unions, or osteotomies, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states it consists of physical components like titanium plates, bone screws, and instruments for implantation, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The OIC Small / Mini Fragment Plate System is a system of titanium plates, screws, and instruments designed for the surgical fixation of bone fractures and other orthopedic issues. It is implanted directly into the body.
- Intended Use: The intended use is for the fixation of fractures, mal-unions, non-unions, or osteotomies in various bones. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The description clearly indicates a device used within the body for structural support and repair, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The OIC Small / Mini Fragment Plate System is indicated for the fixation of fractures, mal-unions, non-unions or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metatarsal.
Product codes
HRS, HWC
Device Description
The OIC Small / Mini Fragment Plate System consists of titanium plates including the Distal Radius, Clavicle, Proximal Humerus, Tibia and Distal Fibula, 1/3 tubular, Hook, Olecranon and Mini Fragment, bone screws and instruments for implantation. The plates come in a variety of sizes and are pre-contoured to match the anatomy of the patient and accept 2.5mm and 3.5mm bone screws are available in three diameters (2.0mm, 2.5mm and 3.5mm) and range in length from 6mm to 130mm. The bone screws are available with both threaded (locking) and non-threaded (non-locking) heads.
The OIC Small / Mini Fragment Plate System is made of titanium alloy in compliance with ASTM F1472 or ASTM F67.
The OIC Small / Mini Fragment Plate System is provided non-sterilized by the medical facility prior to implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metatarsal.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Single cycle bend testing was performed on the OIC plates, Microware Tandry plates and Sythes Locking Plates per ASTM F382, "Standard Specification and Test Method for Metallic Bone Plates". The plates were found to have acceptable mechanical characteristics for the intended uses.
Torsional strength, driver torque and axial pullout strength testing were performed on the OIC 2.0mm Screws, the Microware Tandry predicate and the Synthes predicate per ASTM F543 "Standard Specification and Locking Test Methods for Metallic Medical Bone Screws". The testing shows that the system has acceptable characteristics for the intended uses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K223118, K171904, K090047, K113760, K140814
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 23, 2024
The Orthopaedic Implant Company Douglas Fulton Quality and Operations Manager 770 Smithridge Dr. #400 Reno, Nevada 89502
Re: K242995
Trade/Device Name: OIC Small / Mini Fragment Plate 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: September 25, 2024 Received: September 26, 2024
Dear Douglas Fulton:
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"
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(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-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.
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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-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,
Thomas Mcnamara -S
For: Christopher Ferreira, MS Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
OIC Small / Mini Fragment Plate System
Indications for Use (Describe)
The OIC Small / Mini Fragment Plate System is indicated for the fixation of fractures, mal-unions, non-unions or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metatarsal.
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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510(k) Summary
Prepared 10/21/2024
Name and Address of Manufacturer: The Orthopaedic Implant Company (OIC) 770 Smithridge Drive. Suite 400 Reno, NV 89502
Contact: Douglas Fulton Quality Assurance Manager Telephone: 775-636-8281 Fax: 775-636-8284 Email: doug@orthoimplantcompany.com
Device Identification: Trade Name: OIC Small / Mini Fragment Plate System Common Name: Plate, fixation, bone (primary), Screw, fixation, bone Classification Name: Single/Multiple component metallic bone fixation appliances and accessories (primary), Smooth or threaded metallic bone fixation fastener Classification: Class II, 21 CFR 888.3030 (primary), 888.3040 Panel: Orthopedic Product Code: HRS (primary), HWC
Indications for Use:
The OIC Small / Mini Fragment Plate System is indicated for the fixation of fractures, mal-unions or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metatarsal.
Device Description:
The OIC Small / Mini Fragment Plate System consists of titanium plates including the Distal Radius, Clavicle, Proximal Humerus, Tibia and Distal Fibula, 1/3 tubular, Hook, Olecranon and Mini Fragment, bone screws and instruments for implantation. The plates come in a variety of sizes and are pre-contoured to match the anatomy of the patient and accept 2.5mm and 3.5mm bone screws are available in three diameters (2.0mm, 2.5mm and 3.5mm) and range in length from 6mm to 130mm. The bone screws are available with both threaded (locking) and non-threaded (non-locking) heads.
The OIC Small / Mini Fragment Plate System is made of titanium alloy in compliance with ASTM F1472 or ASTM F67.
The devices conform to the following standards: ASTM F543, Standard Specification and Test Methods for Metallic Medical Bone Screws ASTM F382, Standard Specification and Test Method for Metallic Bone Plates
The OIC Small / Mini Fragment Plate System is provided non-sterilized by the medical facility prior to implantation.
Comparison of Technological Characteristics (Substantial Equivalence): The predicate devices are: Primary predicate: OIC Variable Angle Small Fragment Locking Plate System, K223118 Additional predicates: Microware, Tandry Locking Plate System, K171904 Synthes (USA) 1.5mm Mini Fragment LCP System, K090047 Stryker Orthopaedics, Variax Clavicle System, K113760 Smith & Nephew, Inc., EVOS Mini-Fragment Plating System, K140814
The OIC Small / Mini Fragment Plate System has the following similarities to those which previously received 510(k) concurrence:
· has the same indicated use,
- · uses the same operating principle,
- · incorporates the same design, and
· incorporates the same or similar materials
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Performance Testing:
The worst case example in terms of plate strength for plates in this filing is the Mini Fragment Flat Straight plate. Single cycle bend testing was performed on the OIC plates, Microware Tandry plates and Sythes Locking Plates per ASTM F382, "Standard Specification and Test Method for Metallic Bone Plates". The plates were found to have acceptable mechanical characteristics for the intended uses.
Torsional strength, driver torque and axial pullout strength testing were performed on the OIC 2.0mm Screws, the Microware Tandry predicate and the Synthes predicate per ASTM F543 "Standard Specification and Locking Test Methods for Metallic Medical Bone Screws". The testing shows that the system has acceptable characteristics for the intended uses.
Conclusion:
The product line extension of the OIC Small / Mini Fragment Plate System described in this submission is substantially equivalent to the predicate devices.