(22 days)
Not Found
No
The 510(k) summary describes a line extension of existing orthopedic implants (femoral nails and screws) and focuses on material and size modifications, with no mention of AI or ML technology.
Yes
The device is intended to stabilize various types of femoral fractures, which is a therapeutic function.
No
Explanation: The device is a trochanteric nail system used for stabilizing intertrochanteric and femoral shaft fractures. It is an orthopedic implant for treatment, not for diagnosing conditions.
No
The device description clearly states that the new components are fabricated from titanium alloy, indicating a physical implantable device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "stabilizing various types of intertrochanteric fractures of the femur" and "fixation of femoral fractures." This describes a surgical implant used in vivo (within the body) to treat a physical condition.
- Device Description: The description details "additional sizes of Trochanteric Nails, Long Nails, shorter Lag Screws, additional Cap Screws and additional lengths of Locking Screws" fabricated from "titanium alloy." These are components of a surgical implant system.
- 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 in vitro (outside the body) to analyze biological samples. This device is an orthopedic implant used in vivo.
N/A
Intended Use / Indications for Use
The Trochanteric Gamma3 Nails are intended for use in stabilizing various types of intertrochanteric fractures of the femur. The Long Length Gamma3 Nails are 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 ncck, intertrochanteric, subtrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, pathological fractures, and impending pathological fractures.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
This Special 510(k) submission is a line extension intended to address modifications to the Gamma-Ti Nail System and the Gamma3 Nail System cleared in K013468 and K032244 respectively. The new components in the Gamma3 Nail System include additional sizes of Trochanteric Nails, Long Nails, shorter Lag Screws, additional Cap Screws and additional lengths of Locking Screws. The new components will be fabricated from the same material, titanium alloy, as the components in the predicate nail systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, 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)
Testing demonstrates the comparable mechanical properties of the subject Gamma3 Nail System to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Special 510(k) Summary of Safety and Effectiveness:
Gamma3 Nail System Line Extension
Submission Information
Devic
| Name and Address of the Sponsor of the 510(k) Submission: | Howmedica Osteonics Corp
325 Corporate Dr.
Mahwah, NJ 07430 |
|-----------------------------------------------------------|-------------------------------------------------------------------|
| Contact Person: | Vivian Kelly
Regulatory Affairs Specialist |
| Date of Summary Preparation: | December 23, 2003 |
| Device Identification |
|---|
| ----------------------- |
| Proprietary Name: | Gamma3 Nail System |
|---|---|
| Common Name: | Intramedullary Nail |
This Special 510(k) submission is a line extension intended to address modifications to the Gamma-Ti Nail System and the Gamma3 Nail System cleared in K013468 and K032244 respectively. The new components in the Gamma3 Nail System include additional sizes of Trochanteric Nails, Long Nails, shorter Lag Screws, additional Cap Screws and additional lengths of Locking Screws. The new components will be fabricated from the same material, titanium alloy, as the components in the predicate nail systems.
Classification Name and Reference: Intramedullary Fixation Rod, 21 CFR §888.3020
The Trochanteric Gamma3 Nails are intended for use in stabilizing various types of intertrochanteric fractures of the femur. The Long Length Gamma3 Nails are 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 ncck, intertrochanteric, subtrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, pathological fractures, and impending pathological fractures.
The material used to manufacture the line extension is identical to that of the predicate. Testing demonstrates the comparable mechanical properties of the subject Gamma3 Nail System to the predicate devices.
2
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of a bird or eagle with three curved lines representing its wings or feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2004
Ms. Vivian Kelly Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430
Re: K034002
Trade/Device Name: Gamma3 Trochanteric Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: December 23, 2003 Received: December 24, 2003
Dear Ms. Kelly:
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.
2
Page 2 - Ms. Vivian Kelly
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to promarket 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 vours.
Mark A. Milliman
Celia M. Witten. Ph.D., M.D. Director Division of Gencral, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K 034002
Device Name: Gamma 3 Nail System
Indications For Use:
Gamma3 Trochanteric Nail
The intended use of the subject Trochanteric Gamma 3 Nail is identical to that of the predicate Trochanteric Gamma-Ti and Gamma® Nails. The product is intended for use in stabilizing various types of intertrochanteric fractures of the femur.
Long Length Gamma3 Nail
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 intercondylar notch. Fracture types include basilar neck, intertrochanteric 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)
for Monk n Milke
de of Gener retorative
ological I ses
| Prescription Use | X | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |