(29 days)
Not Found
No
The summary describes a mechanical implant (intramedullary nail) and its material and design modifications. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is described as an intramedullary rod used for fixation of femoral fractures, which fits the definition of a therapeutic device designed to treat a medical condition (fractures).
No
The device is an intramedullary rod designed for the fixation of femoral fractures. It is a surgical implant used for treatment, not for diagnosing conditions or diseases.
No
The device description explicitly states it is a "Long Length Dyax Nail System," which is a physical intramedullary rod fabricated from titanium alloy. It describes material and design modifications to a predicate nail system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the "fixation of femoral fractures." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as an "intramedullary rod" and a "nail system," fabricated from materials like stainless steel and titanium alloy. These are physical implants used to stabilize bones.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases or conditions. This device is a surgical implant used to treat a physical injury.
N/A
Intended Use / Indications for Use
The product is intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intracondylar notch. Fracture types include basilar neck, intertrochanteric, subtrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, malunion, pathological fractures, and impending pathological fractures.
Product codes
HSB
Device Description
The subject device, named the Long Length Dyax Nail System, is a line extension of the Long Length Gamma® Nail System. The predicate Long Length Gamma® Nail System is fabricated from stainless steel. The subject Long Length Dyax Nail System is fabricated from titanium alloy. The design change for the nail involves changing the proximal diameter, changing the distal screw hole diameters and distal hole configuration and adding additional lengths of nails. The 5 mm diameter fully threaded locking screws from the T2 Nail System will be compatible with the Long Length Dyax Nails.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral fractures, femoral neck, intracondylar notch
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
KD13468
Special 510(k) Summary of Safety and Effectiveness: NOV 1 6 2001 Line Extension to the Long Length Gamma® Nail System
Submission Information
| Name and Address of the Sponsor of the 510(k) Submission: | Howmedica Osteonics Corp 59 Route 17 Allendale, NJ 07401-1677 |
|---|---|
| Contact Person: | Karen Ariemma Regulatory Affairs Specialist |
| Date of Summary Preparation: | October 17, 2001 |
Device Identification
| Proprietary Name: | Long Length Dyax Nail (formerly the Long Length Gamma® Nail System) |
|---|---|
| Common Name: | Intramedullary Nail |
| Classification Name and Reference: | Intramedullary Fixation Rod, 21 CFR §888.3020 |
This Special 510(k) submission is intended to address a material modification and design modifications to the predicate Long Length Gamma® Nail System. The subject device, named the Long Length Dyax Nail System, is a line extension of the Long Length Gamma® Nail System. The predicate Long Length Gamma® Nail System is fabricated from stainless steel. The subject Long Length Dyax Nail System is fabricated from titanium alloy. The design change for the nail involves changing the proximal diameter, changing the distal screw hole diameters and distal hole configuration and adding additional lengths of nails. The 5 mm diameter fully threaded locking screws from the T2 Nail System will be compatible with the Long Length Dyax Nails.
The predicate Long Length Gamma® Nail is an intramedullary rod intended to be used in the fixation of femoral fractures' occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. The predicate design is cannulated, with a medial/lateral and anterior/posterior curve.
There is no change in intended use for the modified device when compared to the previously cleared product. The subject Long Length Dyax Nails are substantially equivalent to the existing design of Long Length Gamma® Nails which were determined substantially equivalent via the 510(k) process.
1 Historically, Howmedica Osteonics has intended this product to be used in fracture management as a result of trauma, non-unions, mal-unions, pathological fractures, and impending pathological fractures.
1
Public Health Service
Image /page/1/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2001
Ms. Karen Ariemma Regulatory Affairs Department Howmedica Osteonics 59 Route 17 Allendale, New Jersey 07401
Re: K013468
Trade/Device Name: Howmedica Long Length Dyax Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: October 17, 2001 Received: October 18, 2001
Dear Ms. Ariemma:
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 (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.
2
Page 2 - Ms. Karen Ariemma
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Mark N. Millerson
elia M. Witten, Ph.D., M.D. Director Divison of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
NOV 1 6 2001
510(k) Number (if known): K. 0| 34/6 8
Device Name: Long Length Dyax Nail System (line extension to the Long Length Gamma® Nail System)
Indications For Use:
The product is intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intracondylar notch. Fracture types include basilar neck, intertrochanteric, subtrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, malunion, pathological fractures, and impending pathological fractures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
K 013468
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Mark M Milliken
Division Sign-Off Division of General. Restorative and Neurological Devices
510(k) Number