(60 days)
Not Found
No
The description focuses on the mechanical components and materials of a surgical screw system, with no mention of AI or ML capabilities.
No.
The device is an intramedullary screw system used for fixation of fractures and arthrodesis, which is an implantable surgical tool rather than a therapeutic device that delivers therapy or treatment.
No
This device is an intramedullary screw system used for the fixation of bone fractures and joints, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states the system consists of stainless steel screws and instruments, which are physical 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The OIC Intramedullary Screw System is a surgical implant used for the fixation of bone fractures and joints. It is physically implanted into the body.
- Lack of Diagnostic Function: The device does not analyze biological samples or provide diagnostic information. Its function is purely mechanical and structural.
The information provided clearly describes a surgical implant, not a diagnostic device.
N/A
Intended Use / Indications for Use
The OIC Intramedullary Screw System is indicated for the fixation of intra-articular fractures, malunions, non-unions or osteotomies of small bone fragments, as well as arthrodesis of small joints. The device is intended for use in adults.
Product codes
HWC
Device Description
The OIC Intramedullary Screw System consists of stainless steel screws and instruments to facilitate implantation. The screws come in two diameters, 3.6mm and 4.5mm, and range in length from 25mm to 80mm. The system also includes the instruments used to implant the screws.
The OIC Intramedullary Screw System is provided non-sterilized by the medical facility prior to implantation.
The screws are manufactured material that conforms to:
ASTM F138, Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The device is intended for use in adults.
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)
Torsional, driving torque and axial pullout strength testing were performed on the OIC and Synthes screws per ASTM F543, "Standard Specification and Test Metallic Medical Bone Screw" annex A1, A2 and A3. The screws were found to have acceptable mechanical characteristics for the intended uses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K183603, K050636, K113123, K181184
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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February 13, 2023
Image /page/0/Picture/1 description: The image shows 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 with the full name of the agency on the right. The seal features an eagle with outstretched wings, while the FDA part has the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
Orthopaedic Implant Company Douglas Fulton Quality Assurance Manager 770 Smithridge Dr. #400 Reno, Nevada 89502
Re: K223761
Trade/Device Name: OIC Intramedullary Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: December 13, 2022 Received: December 15, 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
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Indications for Use
510(k) Number (if known)
Device Name
OIC Intramedullary Screw System
Indications for Use (Describe)
The OIC Intramedullary Screw System is indicated for the fixation of intra-articular fractures, malunions, non-unions or osteotomies of small bone fragments, as well as arthrodesis of small joints. The device is intended for use in adults.
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 2/9/2023
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 Intramedullary Screw System Common Name: Screw, Fixation, Bone Regulation Name, Number: Smooth or Threaded Metallic Bone Fixation Fastener, 21 CFR 888.3040 Classification: Class II Panel: Orthopedic Product Code: HWC
Indications for Use:
The OIC Intramedullary Screw System is indicated for the fixation of intra-articular fractures, malunions, non-unions or osteotomies of small bone fragments, as well as arthrodesis of small joints. The device is intended for use in adults.
Device Description:
The OIC Intramedullary Screw System consists of stainless steel screws and instruments to facilitate implantation. The screws come in two diameters, 3.6mm and 4.5mm, and range in length from 25mm to 80mm. The system also includes the instruments used to implant the screws.
The OIC Intramedullary Screw System is provided non-sterilized by the medical facility prior to implantation.
The screws are manufactured material that conforms to:
ASTM F138, Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
Comparison of Technological Characteristics (Substantial Equivalence):
The primary predicate device is: Exsomed Corporation K183603 Innate Cannulated Screw System Additional predicate devices: Synthes USA K050636 Synthes 3.0mm Headless Compression Screws Orthopaedic Implant Company K113123 OIC Cannulated Screw System Orthopaedic Implant Company K181184 OIC Intramedullary Nail System
The OIC Intramedullary Screw System has the following similarities to those which previously received 510(k) concurrence:
· has the same indicated use,
· uses the same operating principle,
· incorporates a very similar design, and
· incorporates the same materials
Performance Testing:
Torsional, driving torque and axial pullout strength testing were performed on the OIC and Synthes screws per ASTM F543, "Standard Specification and Test Metallic Medical Bone Screw" annex A1, A2 and A3. The screws were found to have acceptable mechanical characteristics for the intended uses.
Conclusion:
The OIC Intramedullary Screw System described in this substantially equivalent to the predicate devices.