(118 days)
No
The description focuses on the mechanical components and materials of an intramedullary nail system for fracture fixation. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is an intramedullary nail system intended for surgical management of bone fractures, functioning as an implant rather than a device for therapy.
No
This device is an intramedullary nail system used for the surgical management of fractures, not for diagnosing conditions.
No
The device description explicitly states it consists of titanium nails, locking bolts, lag screws, and instruments for implantation, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for fixing bone fractures (femoral and tibial). This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical implants (nails, bolts, screws) made of titanium, designed to be surgically inserted into the body. This is consistent with a surgical implant, not a device used to examine specimens from the body.
- No mention of in vitro testing: The text does not mention any analysis of samples taken from the human body (like blood, urine, tissue, etc.), which is the core function of an IVD.
Therefore, the OIC Intramedullary Nail System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The OIC Intramedullary Nail System is intended for surgical management of femoral and tibial fractures including open and closed fractures, pseudarthrosis and correction osteotomy, pathologic fractures, impending pathologic fractures, tumor resections, nonunions and malunions. The hip nails may be used for basilar neck, subtrochanteric and intertrochanteric fractures. The femoral nails may be used for fractures of the femur below the hip joint including ipsilateral femur fractures, fractures proximal to a total knee arthroplasty and supracondylar fractures, including those with intra-articular extension.
Product codes
HSB
Device Description
The OIC Intramedullary Nail System consists of titanium nail for the tibia and femur, nail locking bolts, lag screws and instruments for implantation. The nails come in a variety of sizes and are pre-contoured to match the anatomy of the patient and accept 5.0mm locking bolts range in length from 20mm to 130mm. The lag screws are 10.5mm in diameter and range in length from 70mm to 120mm.
The intramedullary nails, bolts and screws are made of titanium alloy Ti-6Al-4V ELI in compliance with ASTM F136 or with Ti6Al4V in compliance with ASTM F1472.
The implants contained in the OIC Intramedullary Nail System are provided in both the non-sterile condition. Implants provided in the sterile condition will be sterilized with gamma radiation in accordance with methods and protocols outlined in ISO 11137-1:2006.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral and tibial fractures, hip joint, femur
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)
The nails and lag screws of the OlC Intramedulary Nail System were evaluated using a geometric comparison. The nails and the nail-lag screw constructs were found to have acceptable mechanical characteristics for the intended uses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K043431, K101438, K112059, K003018
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's logo, which consists of a stylized caduceus with three figures in profile facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 9, 2015
Orthopaedic Implant Company Mr. Douglas Fulton Ouality Assurance Manager 316 California Ave #701 Reno, Nevada 89509
Re: K150655
Trade/Device Name: OIC Intramedullary Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: June 3, 2015 Received: June 4, 2015
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K150655
Device Name
OIC Intramedullary Nail System
Indications for Use (Describe)
The OIC Intramedullary Nail System is intended for surgical management of femoral and tibial fractures including open and closed fractures, pseudarthrosis and correction osteotomy, pathologic fractures, impending pathologic fractures, tumor resections, nonunions and malunions. The hip nails may be used for basilar neck, subtrochanteric and intertrochanteric fractures. The femoral nails may be used for fractures of the femur below the hip joint including ipsilateral femur fractures, fractures proximal to a total knee arthroplasty and supracondylar fractures, including those with intra-articular extension.
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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Prepared 06/22/2015
Name and Address of Manufacturer The Orthopaedic Implant Company (OIC) 316 California Ave #701 Reno, NV 89509
Contact Douglas Fulton Quality Assurance Manager Telephone: 775-636-8281 Fax: 775-636-8284 Email: doug@orthoimplantcompany.com
Device Identification Trade Name: OIC Intramedullary Nail System Common Name: Hip Nail, Femoral Nail, Tibial Nail Classification Name: Rod, Fixation, Intramedullary and Accessories Classification: Class II, 21 CFR 888.3020 Panel: Orthopedic Product Code: HSB
Indications for Use
The OIC Intramedullary Nail System is intended for surgical management of femoral and tibial fractures including open and closed fractures, pseudarthrosis and correction osteotomy, pathologic fractures, impending pathologic fractures, tumor resections, nonunions and malunions. The hip nails may be used for basilar neck, subtrochanteric and intertrochanteric fractures. The femoral nails may be used for fractures of the hip joint including ipsilateral femur fractures fractures proximal to a total knee arthroplasty and supracondylar fractures, including those with intraarticular extension.
Device Description
The OIC Intramedullary Nail System consists of titanium nail for the tibia and femur, nail locking bolts, lag screws and instruments for implantation. The nails come in a variety of sizes and are pre-contoured to match the anatomy of the patient and accept 5.0mm locking bolts range in length from 20mm to 130mm. The lag screws are 10.5mm in diameter and range in length from 70mm to 120mm.
The intramedullary nails, bolts and screws are made of titanium alloy Ti-6Al-4V ELI in compliance with ASTM F136 or with Ti6Al4V in compliance with ASTM F1472.
The implants contained in the OIC Intramedullary Nail System are provided in both the non-sterile condition. Implants provided in the sterile condition will be sterilized with gamma radiation in accordance with methods and protocols outlined in ISO 11137-1:2006.
Substantial Equivalence Primary predicate device: K043431 Gamma 3 Nail System Additional predicate devices: T2 Greater Trochanter Nail (GTN) K101438 K112059 T2 Femoral Nail K003018 Titan Tibial Nail Reference device: K131548 Synthes Trochanteric Fixation Nail - Advanced System
The new device is substantially equivalent to the predicate devices in regards to intended use, materials, and function. There are no significant differences between the OIC Intramedulary Nail System and the predicate devices listed above. Any minor differences have no effect on safety and effectiveness.
The nails and lag screws of the OlC Intramedulary Nail System were evaluated using a geometric comparison. The nails and the nail-lag screw constructs were found to have acceptable mechanical characteristics for the intended uses.