(110 days)
No
The device description and performance studies focus on the mechanical properties and materials of the bone plates and screws, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device is used for the fixation of fractures, mal-unions, nonunions or osteotomies, which are medical treatments.
No
This device is a surgical implant designed for the fixation of fractures and osteotomies, not for diagnosing medical conditions.
No
The device description explicitly states it consists of titanium plates, bone screws, and instruments for implantation, which are all 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, mal-unions, nonunions, or osteotomies. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of plates, screws, and instruments for implantation. These are physical implants and tools used in surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function. It is a therapeutic device used to stabilize bone.
Therefore, the OIC Variable Angle Small Fragment Locking Plate System is a surgical implant system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The OIC Variable Angle Small Fragment Locking Plate System is indicated for the fixation of fractures, mal-unions, nonunions or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metatarsal.
Product codes
HRS, HWC
Device Description
The OIC Variable Angle Small Fragment Locking Plate System consists of titanium plates for the Distal Radius, Clavicle, Proximal Humerus, Tibia, Distal Fibula, a Low Profile 1/3 Tubular and Hook plate, bone screws and instruments for implantation. The plates come in a variety of sizes and accept 2.5mm, 3.5mm and 4.0mm bone screws. The bone screws are available in two diameters of cortex screws (2.5mm and a 4.0mm cancellous screw. They range in length from 6mm to 130mm. The cortex screws are available with both threaded (locking) and non-threaded (non-locking) heads.
The OIC Variable Angle Small Fragment Locking Plate System is made of titanium alloy in compliance with ASTM F136, ASTM F1472 or ASTM F67.
The OIC Variable Angle Small Fragment Locking Plate System is provided non-sterile and is steam-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
Single cycle bend testing was performed on the OIC Low Profile 1/3 Tubular Plate and the Synthes (USA) One-Third Tubular Plate with Collar per ASTM F382, "Standard Specification and test Method for Metallic Bone Plates". The strength of the Hook plate was evaluated against the Microware plate using engineering analysis. The plates were found to have acceptable mechanical characteristics for the intended uses. A geometric comparison and bending strength, torsional strength and an axial pullout strength calculation was performed on the 4.0mm Cancellous Screws as compared to the worst case example of screws contained in the OIC predicate - the 2.5mm Non-locking Screw. The comparison and calculations show that the system has acceptable characteristics for the intended uses.
Key Metrics
Not Found
Predicate Device(s)
Microware, Tandry Locking Plate System, K171904, Synthes (USA) 3.5mm LCP Hook Plate, K082072, Synthes (USA) TI One-Third Tubular Plate with Collar, (Pre-Amendment)
Reference Device(s)
OIC Variable Angle Small Fragment Locking Plate System, K140357
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
January 21, 2023
Image /page/0/Picture/1 description: The image contains 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.
Orthopaedic Implant Company Douglas Fulton Quality Assurance Manager 770 Smithridge Dr. #400 Reno, Nevada 89502
Re: K223118
Trade/Device Name: OIC Variable Angle Small Fragment Locking 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: December 15, 2022 Received: December 19, 2022
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 (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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-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,
Shumaya Ali-S
Shumaya Ali, M.P.H. 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
2
Indications for Use
510(k) Number (if known) K223118
Device Name
OIC Variable Angle Small Fragment Locking Plate System
Indications for Use (Describe)
The OIC Variable Angle Small Fragment Locking Plate System is indicated for the fixation of fractures, mal-unions, nonunions 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 - K223118
Prepared 1/16/2023
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 Variable Angle Small Fragment Locking Plate System Common Name: Plate, fixation, bone 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, HWC
Indications for Use:
The OIC Variable Angle Small Fragment Locking Plate System is indicated for the fixation of fractures, fusions, malunions, non-unions or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metatarsal.
Device Description:
The OIC Variable Angle Small Fragment Locking Plate System consists of titanium plates for the Distal Radius, Clavicle, Proximal Humerus, Tibia, Distal Fibula, a Low Profile 1/3 Tubular and Hook plate, bone screws and instruments for implantation. The plates come in a variety of sizes and accept 2.5mm, 3.5mm and 4.0mm bone screws. The bone screws are available in two diameters of cortex screws (2.5mm and a 4.0mm cancellous screw. They range in length from 6mm to 130mm. The cortex screws are available with both threaded (locking) and non-threaded (non-locking) heads.
The OIC Variable Angle Small Fragment Locking Plate System is made of titanium alloy in compliance with ASTM F136, ASTM F1472 or ASTM F67.
The devices conform to the following standards: ASTM F543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws ASTM F382, Standard Specification and Test Method for Metallic Bone Plates
The OIC Variable Angle Small Fragment Locking Plate System is provided non-sterile and is steam-sterilized by the medical facility prior to implantation.
Comparison of Technological Characteristics (Substantial Equivalence): The predicate devices are: OIC Variable Angle Small Fragment Locking Plate System, K140357, June 9, 2014 Primary predicate: Microware, Tandry Locking Plate System, K171904, Sept. 18, 2018 Secondary predicates: Synthes (USA) 3.5mm LCP Hook Plate, K082072, Nov. 7, 2008 Synthes (USA) TI One-Third Tubular Plate with Collar, (Pre-Amendment)
The OIC Variable Angle Small Fragment Locking 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
4
Performance Testing:
The worst case example in terms of plate strength for plates in this filing is the 1/3 tubular plate. Single cycle bend testing was performed on the OIC Low Profile 1/3 Tubular Plate and the Synthes (USA) One-Third Tubular Plate with Collar per ASTM F382, "Standard Specification and test Method for Metallic Bone Plates". The strength of the Hook plate was evaluated against the Microware plate using engineering analysis. The plates were found to have acceptable mechanical characteristics for the intended uses. A geometric comparison and bending strength, torsional strength and an axial pullout strength calculation was performed on the 4.0mm Cancellous Screws as compared to the worst case example of screws contained in the OIC predicate - the 2.5mm Non-locking Screw. The comparison and calculations show that the system has acceptable characteristics for the intended uses.
Conclusion:
The product line extension of the OIC Variable Angle Small Fragment Locking Plate System described in this submission is substantially equivalent to the predicate devices.