(18 days)
Not Found
Not Found
No
The summary describes a mechanical implant (screws) and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the fixation of various long bones, such as the femur, which directly aids in healing and restoring normal function to an injured or diseased body part.
No
Explanation: The device description clearly states its purpose is for "fixation of various long bones" and describes physical characteristics like "self-drilling and self-tapping tips" and "threads below the head...to engage with threaded holes of currently marketed Synthes LCP® plating systems." These are all features of a surgical implant/fixation device, not a diagnostic tool that identifies or characterizes a disease or condition.
No
The device description clearly describes physical hardware components (screws with specific features and dimensions) intended for surgical implantation, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the screws are for the "fixation of various long bones, such as the femur." This is a surgical procedure performed in vivo (within the living body).
- Device Description: The description details a physical implantable device (screws) used for bone fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used for diagnostic purposes on samples taken from the body, not for direct surgical intervention on the body itself.
N/A
Intended Use / Indications for Use
Synthes 5.0/7.3 mm Cannulated Locking screws are intended to be used with existing Synthes LCP® plating systems for the fixation of various long bones, such as the femur.
Product codes
JDW
Device Description
The Synthes 5.0/7.3 mm Cannulated Locking Screws feature self-drilling and self-tapping tips, have a flat head profile with rounded edges with a hex drive recess. They are available in additional lengths ranging from 100 - 145mm. The threads below the head of each locking screw are designed to engage with the threaded holes of currently marketed Synthes LCP® plating systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
various long bones, such as the femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Synthes 5.0/7.3 mm Cannulated Locking Screws
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
APR 1 2 2004
040765
page 1 of 1
3.0 Summary of Safety and Effectiveness Information [510(k) Summary]
| SPONSOR: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700
Contact: Lisa M. Boyle |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Synthes 5.0/7.3 mm Cannulated Locking Screws |
| CLASSIFICATION: | Class II § 21 CFR 888.3040: Smooth or Threaded Metallic Bone Fixation
Fastener. |
| PREDICATE DEVICE: | Synthes 5.0/7.3 mm Cannulated Locking Screws |
| DEVICE DESCRIPTION: | The Synthes 5.0/7.3 mm Cannulated Locking Screws feature self-drilling
and self-tapping tips, have a flat head profile with rounded edges with a hex
drive recess. They are available in additional lengths ranging from 100 -
145mm. The threads below the head of each locking screw are designed to
engage with the threaded holes of currently marketed Synthes LCP®
plating systems. |
| INTENDED USE: | Synthes 5.0/7.3 mm Cannulated Locking screws are intended to be used
with existing Synthes LCP® plating systems for the fixation of various long
bones, such as the femur. |
| SUBSTANTIAL
EQUIVALENCE: | Comparative information presented supports substantial equivalence. |
| MATERIAL | Stainless Steel |
.
Confidential
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized symbol consisting of three abstract human figures connected by flowing lines, representing the department's focus on people and their well-being.
Public Health Service
APR 1 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Rc: K040765
Trade/Device Name: Synthes (USA) 5.0/7.3 mm Cannulated Locking Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JDW Dated: March 24, 2004 Received: March 25, 2004
Dear Ms. Boyle:
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 adultcration.
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
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 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,
L. Mark A. Mulhausen
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
Indications for Use Statement 2.0
Page _ 1_ of _________________________________________________________________________________________________________________________________________________________________
K040765 510(k) Number (if known):
Synthes (USA) 5.0/7.3 mm Cannulated Locking Screw Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications: Synthes 5.0/7.3 mm Cannualted Locking Screws are intended to be used with existing Synthes LCP® plating systems for the fixation of various long bones, such as the femur.
X Prescription Use (Per 21 CFR 801.109)
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Over-The-Counter Usc
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Synthes (USA)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sig...)
Division of General, Restorative,
and Neurological Devices
Confidential 510(k) N: K040765
Confidential
Synthes (USA) 5.0/7/3 mm Cannulated Locking Screws
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