(182 days)
Not Found
No
The device description and intended use are purely mechanical, describing a set of screws and a bushing for bone fixation. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
No.
The device is described as an implantable fixation screw for bone fixation and management of fractures, which is a structural rather than therapeutic function.
No
The device is a screw set used for bone fixation and reconstructive surgeries, not for diagnosing medical conditions.
No
The device description clearly states it consists of an implantable fixation screw and a threaded bushing, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Latarjet Cortical Screw Set is a surgical implant used for bone fixation during shoulder surgery. It is physically implanted into the body to provide structural support.
- Lack of Specimen Analysis: The device does not interact with or analyze any specimens taken from the body. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the Latarjet Cortical Screw Set clearly falls outside the definition and function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Latarjet Cortical Screw Set is intended to provide the orthopedic surgeon a means of bone fixation and to assist in the management of fractures and reconstructive surgeries.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Latarjet Cortical Screw Set consists of an implantable fixation screw which is used for fixation of bone grafts or bone fragments to cortical bone in shoulder surgeries. The fixation screws are offered in the following overall lengths: 36mm - 42mm. (features- other than the overall length- are identical on all). The set also includes a threaded bushing which attaches to the proximal end of the fixation screw. Its purpose is to position the screw firmly and safely during the fixation procedure. The bushing is provided in one size. The fixation screw and bushing are supplied in either in Titanium alloy or Stainless Steel. The Latarjet Cortical Screw Set is supplied non-sterile, for single patient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, specifically for shoulder surgeries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic surgeon
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.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K083096 (pg. 1 of 1)
510(k) Summary of Safety & Effectiveness
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
| 1. (a) | Submitter
Address: | George J. Hattub
MedicSense, USA
291 Hillside Avenue
Somerset, MA 02726
www.medicsense.com | APR 1 7 2009 |
|--------|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| 1. (b) | Manufacturer
Address: | T.A.G. Medical Products
D. N. Ashrat
Kibbutz Gaaton 25130, Israel | |
| | Mfg. Phone: | Tel.: 972-3-647-4840 | |
| | Contact Person: | Dan Moor | |
| | Date: | April 16, 2009 | |
| 2. | Device &
Classification
Name: | Bone Fixation Screw, class II device (product code HWC).
Latarjet Cortical Screw Set | |
| 3. | Predicate Device: | Depuy Cannulated Bone Screw K903811
Synthes 3mm Cannulated Bone Screw System K892823 | |
| 4. | Description: | The Latarjet Cortical Screw Set consists of an implantable fixation screw
which is used for fixation of bone grafts or bone fragments to cortical bone in
shoulder surgeries. The fixation screws are offered in the following overall
lengths: 36mm - 42mm. (features- other than the overall length- are
identical on all). The set also includes a threaded bushing which attaches to
the proximal end of the fixation screw. Its purpose is to position the screw
firmly and safely during the fixation procedure. The bushing is provided in
one size. The fixation screw and bushing are supplied in either in Titanium
alloy or Stainless Steel. The Latarjet Cortical Screw Set is supplied non-
sterile, for single patient use. | |
| 5. | Intended Use: | The Latarjet Cortical Screw Set is intended to provide the orthopedic
surgeon a means of bone fixation and to assist in the management of
fractures and reconstructive surgeries. | |
| 6. | Comparison of
Technological
Characteristics: | With respect to its indication for use, the Latarjet Cortical Screw Set is
substantially equivalent to its predicate device in that it intended for the
same clinical purpose. With respect to technology, the design is similar as
confirmed by comparison, and the performance is the same as verified by
validation. Based upon this, T.A.G. Medical Products believes that its device
is safe and effective because it performs the same function in the same
manner. | |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
T.A.G. Medical Products % MedicSense, USA Mr. George J. Hattub 291 Hillside Avenue Somerset, Massachusetts 02726
.
APR 1 7 2009
Re: K083096
Trade/Device Name: Latarjet Cortical Screw Set Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 5, 2009 Received: March 9, 2009
Dear Mr. Hattub:
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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- Mr. George J. Hattub
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 of adverse events.under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
avn
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K083096
Indications for Use
510(k) Number (if known):
Device Name: Latarjet Cortical Screw Set
Indications For Use: The Latarjet Cortical Screw Set is intended to provide the orthopedic surgeon a means of bone fixation and to assist in the management of fractures and reconstructive surgeries.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Division of General, Restorative, and Neurological Devices
Page 1 of 1
- Number K063096