(28 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical implant (lag screw) with design modifications to its physical characteristics (thread diameter, radius, cutting flute). There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device, a lag screw, is intended for the fixation and stabilization of femoral fractures, which is a therapeutic purpose.
No
The device is described as a "Lag Screw" intended for fixation and stabilizing of femoral fractures. This indicates a therapeutic or surgical purpose, not a diagnostic one.
No
The device description clearly states it is a "Lag Screw" and describes physical design modifications (thread diameter, radius, cutting flute design), indicating it is 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 describes the device as being used for the fixation and stabilization of femoral fractures. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "Lag Screw" used with "Nails," which are implants for bone fixation. This is consistent with a surgical implant, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) from the human body to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are used in vitro (outside the body) to examine specimens. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
The Gamma 3 Lag Screw is intended to be used with both the Long Length Dyax Nail and the Trochanteric Dyax Nail.
Intended Use for the Long Length Dyax 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 intracondylar 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.
Intended Use for the Trochanteric Dyax Nail
The product is intended for use in stabilizing various types of intertrochanteric fractures of the femur.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
This Special 510(k) submission is intended to address a design modification of the Dyax Lag Screw to create the subject device which is referred to as the Gamma 3 Lag Screw. The design modification involves changes to the thread diameter; thread radius and cutting flute design. The subject device is intended to be used with both the Long Length Dyax Nail and the Trochanteric Dyax Nail. The design modification involves changes to the thread diameter; thread radius and cutting flute design
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)
Not Found
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.
Not Found
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
Design Modification of the Dyax Lag Screw to the Gamma 3 Lag Screw
Special 510(k) Premarket Notification
Special 510(k) Summary: Design Modification of the Dyax Lag Screw to the Gamma 3 Lag Screw
Submission Information
Contact Person:
Name and Address of the Sponsor of the 510(k) Submission:
Howmedica Osteonics Corp 59 Route 17 Allendale, NJ 07401-1677
Karen Ariemma Regulatory Affairs Specialist
Date of Summary Preparation:
February 27, 2002
Device Identification
Gamma 3 Lag Screw Proprietary Name: Intramedullary Nail Common Name: Classification Name and Reference: Intramedullary Fixation Rod, 21 CFR §888.3020
This Special 510(k) submission is intended to address a design modification of the Dyax Lag Screw to create the subject device which is referred to as the Gamma 3 Lag Screw. The design modification involves changes to the thread diameter; thread radius and cutting flute design. The subject device is intended to be used with both the Long Length Dyax Nail and the Trochanteric Dyax Nail. The design modification involves changes to the thread diameter; thread radius and cutting flute design
There is no change in intended use for the modified device when compared to the previously cleared product. The subject Gamma 3 Lag Screws are substantially equivalent to the existing design of Dyax Nail Lag Screw that were determined substantially equivalent via the 510(k) process.
2
K020677
page 1 of 1
MAR 2 9 2002
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circle's perimeter.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 2002
Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
Re: K020677
Trade/Device Name: Gamma 3 Lag Screw Regulation Number: 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: February 27, 2002 Received: March 1, 2002
Dear Ms. Ariemma:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave a sove 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 for ass surfalse in the encrease of 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. 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,
ho Mark N-Millisser
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K () JO6 7 7
Device Name: Gamma 3 Lag Screw
Indications For Use:
The Gamma 3 Lag Screw is intended to be used with both the Long Length Dyax Nail and the Trochanteric Dyax Nail.
Intended Use for the Long Length Dyax 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 intracondylar 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.
Intended Use for the Trochanteric Dyax Nail
The product is intended for use in stabilizing various types of intertrochanteric fractures of the femur.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Mark N. Mulkerson
Division Sign-Division of General, Restorative and Neurological Devices
S . . K ) Number _