(17 days)
Not Found
K/DEN numbers are not found in the provided text.
No
The summary describes a mechanical implant (nail) for fracture stabilization and mentions material and design modifications, with no indication of software, image processing, or AI/ML technology.
Yes
The device is intended for stabilizing various types of intertrochanteric fractures of the femur, which is a therapeutic purpose.
No
Explanation: The device is a nail system used to stabilize fractures (treatment), not to diagnose them.
No
The device description clearly states it is a "Trochanteric Gamma 3 Nail" and part of a "Nail System" which includes physical components like nails, lag screws, locking screws, and end caps. This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "stabilize various types of intertrochanteric fractures of the femur." This is a surgical implant used in vivo (within the body) to treat a physical condition.
- Device Description: The device is described as a "Trochanteric Gamma 3 Nail" and part of a "Nail System" with accessories like screws. This is a mechanical device for orthopedic surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests in vitro (outside the body) on biological samples. This device is an orthopedic implant used in vivo.
N/A
Intended Use / Indications for Use
The intended use of the Trochanteric Gamma 3 Nail is identical to that of the predicate Trochanteric Dyax 8 and Gamma® Nails. The product is intended for use in stabilizing various types of intertrochanteric fractures of the femur.
Product codes
HSB
Device Description
This Special 510(k) submission is a line extension to the Trochanteric Dyax® and Gamma® Nail Systems. This line extension is intended to address a material modification and design modifications to the predicate Trochanteric Dyax® and Gamma® Nail Systems. Both the subject and predicate systems offer trochanteric nails, and offer various accessories such as lag screws, locking screws, and end caps. The Trochanteric Gamma 3 Nail in the Gamma 3 Nail System also has the same basic design concepts as the currently available Trochanteric Dyax and Gamma® Nail Systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Mechanical testing demonstrated comparable mechanical properties to the predicate components.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "HUMAN SERVICES - USA" are arranged in a circular pattern above the eagle. The words "DEPARTMENT OF" are arranged in a circular pattern below the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2005
Ms. Vivian Kelly Regulatory Affairs Consultant Howmedica Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677
Re: K032244
Trade/Device Name: Gamma 3 Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: July 16,2003 Received: July 22,2003
Dear Ms. Kelly:
This letter corrects our substantially equivalent letter of August 8, 2003 regarding the Regulation Number, Regulation Name and Product Code of the above device. The correct information is listed above.
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 (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 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
1
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.
This letter will allow you to continue 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Stipk Rurla
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Nurnbcr (if known): K O 322
Device Name: Gamma 3 Nail System
Indications For Use:
The intended use of the subject Trochanteric Gamma 3 Nail is identical to that of the predicate Trochanteric Dyax 8 and Gamma® Nails. The product is intended for use in stabilizing various types of intertrochanteric fractures of the femur.
Muriam C. Provost
Division Sign (Division of General, Restorative and Neurological Devices
-K632244 510(k) Number—
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE F NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use -
OR
Over-The-Counter Use -
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
3
Special 510(k) Premarket Notification
AUG - 8 2003 Summary of Safety and Effectiveness
32294
page 1 of 1
Line Extension to the Trochanteric Dyax® & Gamma® Nail Systems
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: | Vivian Kelly
Regulatory Affairs Consultant
Phone: 201-831-5581
Fax: 201-831-6038 |
Date of Summary Preparation: July 16, 2003
Device Identification
| Proprietary Name: | Gamma 3 Nail System |
|---|---|
| Common Name: | Intramedullary Nail |
| Classification Name and Reference: | Intramedullary Fixation Rod, 21 CFR §888.3020 |
This Special 510(k) submission is a line extension to the Trochanteric Dyax® and Gamma® Nail Systems. This line extension is intended to address a material modification and design modifications to the predicate Trochanteric Dyax® and Gamma® Nail Systems. Both the subject and predicate systems offer trochanteric nails, and offer various accessories such as lag screws, locking screws, and end caps.
The intended use of the subject device is identical to that of the predicate Trochanteric Dyax Nails. The device is intended for use in stabilizing various types of intertrochanteric fractures of the femur. The Trochanteric Gamma 3 Nail in the Gamma 3 Nail System also has the same basic design concepts as the currently available Trochanteric Dyax and Gamma® Nail Systems. Mechanical testing demonstrated comparable mechanical properties to the predicate components.