(18 days)
No
The device description and summary of performance studies focus on mechanical fixation and equivalence to predicate devices, with no mention of AI or ML capabilities.
Yes
The device is described as an "Intramedullary Fixation System" intended for the surgical fixation of fractures and surgical osteotomies, which are therapeutic interventions.
No
The device is described as an intramedullary fixation system for surgical fixation of fractures and osteotomies, which is a therapeutic rather than a diagnostic function. It is used to secure bone fragments and lock a rod into position, not to identify or assess a condition.
No
The device description clearly outlines physical components like an intramedullary rod, guide, screws, and a compression mechanism, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The OlecraNail™ Intramedullary Fixation System is a surgical implant used to fix bone fractures. It is inserted directly into the body.
- Intended Use: The intended use is "surgical fixation of all fractures and surgical osteotomies of the proximal ulna." This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The information provided clearly describes a surgical device used for treatment, not a diagnostic test.
N/A
Intended Use / Indications for Use
This device is intended for the surgical fixation of all fractures and surgical osteotomies of the proximal ulna in the acute or chronic settings. No changes have occurred to the Intended Use from the previously cleared device. the OlecraNail Intramedullary Fixation System (K081356). The OlecraNail™ Intramedullary Fixation System and accessories are intended for the surgical fixation of all fractures and surgical osteotomies of the proximal ulna in the acute or chronic setting.
Product codes
HSB
Device Description
The OlecraNail™ intramedullary rod is a solid bore, stainless steel, tapered rod that is inserted into a pre-drilled hole into the medullary canal of the proximal ulna. Once the device is in place, a carbon fiber composite guide is used to drill into the bone and insert several screws through the bone and rod to secure all bone fragments and lock the rod into position. During this process, compression at the fracture site may be obtained by manually turning a knob to activate the compression mechanism. After all screws are placed, the guide may then be detached using a break-away mechanism.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal ulna
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical
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
A review of the test data for the subject devices indicates that they are equivalent to the predicate devices currently in clinical use and are capable of withstanding expected in vivo loading without failure.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
Attachment 8
FEB 1 1 2009
510 (k) Summary
Submitter's Name and Address
Contact Person
Date of Summary:
Proprietary Name of Device:
Common/Usual Name:
Classification Name:
Legally Marketed Equivalent Devices:
Mylad Orthopedic Solutions, LLC 8803 Windy Creek Way McLean, Virginia 22102 Phone: (703)738-6547 Facsimile: (661)885-4447
Scott Edwards, M.D.
December 20, 2008
OlecraNail™ Intramedullary Fixation System
intramedullary nail
Rod, Fixation, Intramedullary and Accessories per 21 C.F.R. § 888.3020
OlecraNail™ Intramedullary Fixation Device (K081356) Smith and & Nephew TriGen Meta-Nail Retrograde Femoral and Tibial Nails (K061019) Hand Innovations Distal Volar Radius. Fracture Repair System (K002775)
Summary of Device:
The OlecraNail™ intramedullary rod is a solid bore, stainless steel, tapered rod that is inserted into a pre-drilled hole into the medullary canal of the proximal ulna. Once the device is in place, a carbon fiber composite guide is used to drill into the bone and insert several screws through the bone and rod to secure all bone fragments and lock the rod into position. During this process, compression at the fracture site may be obtained by manually turning a knob to activate the compression mechanism. After all screws are placed, the guide may then be detached using a break-away mechanism.
1
Intended Use:
This device is intended for the surgical fixation of all fractures and surgical osteotomies of the proximal ulna in the acute or chronic settings. No changes have occurred to the Intended Use from the previously cleared device. the OlecraNail Intramedullary Fixation System (K081356).
Technological Characteristics of the Device Compared to the Predicate Devices:
The principle of operation of the subject devices is identical to that of the predicates. There are no changes in intended use, performance specifications or method of operation. A review of the test data for the subject devices indicates that they are equivalent to the predicate devices currently in clinical use and are capable of withstanding expected in vivo loading without failure.
Substantial equivalence for the OlecraNail™ Intramedullary Fixation System is based on their similarities in indications for use, design features, operational principles, and material composition when compared to the predicate devices cleared under the following submissions: Olecranail™ Intramedullary Fixation System (K081356), Smith & Nephew TriGen Meta-Nail Retrograde Femoral and Tibial Nails (K061019), and Hand Innovations Distal Volar Radius Fracture Repair System (K002775).
Miscellaneous Information:
Carbon fiber composite material, 17-6 Condition H-900, titanium 6-4 alloy are supplied, inspected, and certified to meet ASTM standards.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three intertwined snakes wrapped around a staff with wings at the top. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2009
Mylad Orthopedic Solutions, LLC % Scott G. Edwards, M.D. President 8803 Windy Creek Way McLean, Virginia 22102
Re: K090091
Trade/Device Name: OlecraNail IM Intramedullary Fixation System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulation Class: Class II Product Code: HSB Dated: January 13, 2009 Received: January 14, 2009
Dear Dr. Edwards:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Scott G. Edwards, M.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milken
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment 2
Indications for Use Statement
510(k) K090091 Number (if known) OlecraNailTM Intramedullary Fixation System Device Name The OlecraNail™ Intramedullary Fixation System and accessories are Indications for Use intended for the surgical fixation of all fractures and surgical · osteotomies of the proximal ulna in the acute or chronic setting.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801. 109)
OR
Over-The-Counter Use
Sonata
(Division Sign-Oil) Division of Surgic ), Orthopedic, and Restorative Devices
510(k) Number K090091
LEGAL02/31014278v1