(78 days)
Not Found
Not Found
No
The summary describes a mechanical orthopedic screw and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as a screw intended for fixation of fractures and non-unions, which is a structural support device, not one that treats or prevents a disease or condition.
No
Explanation: The device is described as a surgical screw for fixation of fractures and non-unions, not for diagnosing conditions.
No
The device description clearly states it is a physical screw made of stainless steel and titanium, intended for surgical fixation. It is a hardware device, not software.
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.
- Device Description and Intended Use: The provided information clearly states that the Synthes 3.5 mm Cortex Screws are intended for the fixation of fractures, osteotomies, and non-unions in various bones. This is a surgical implant used directly within the body for structural support and healing.
There is no mention of analyzing biological specimens or providing diagnostic information based on such analysis.
N/A
Intended Use / Indications for Use
The Synthes 3.5 mm Cortex Screws are intended for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula.
Product codes
HWC
Device Description
The 3.5 mm cortex screws are self-tapping, have a stardrive recess, and are manufactured from stainless steel and titanium. The self-tapping screws are available in various lengths ranging from 10-150 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Per 21 CFR 801.109)
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)
Synthes 3.5 mm Cortex 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
Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold black letters. To the left of the word is a logo that appears to be a stylized letter inside of a circle. There is a horizontal line below the word.
3.0
K 04/3/85
| 510(k) Summary | Page 1 of 1 |
|---|---|
| Sponsor: | Synthes (USA) |
| 1690 Russell Road | |
| Paoli, PA 19301 | |
| (610) 647-9700 | |
| Device Name: | Synthes 3.5mm Cortex Screws |
| Classification: | 21 CFR 888.3040: Smooth or Threaded Metallic Bone Fixation |
| Fastener. | |
| Predicate Devices: | Synthes 3.5 mm Cortex Screws |
| Device Description: | The 3.5 mm cortex screws are self-tapping, have a stardrive recess, |
| and are manufactured from stainless steel and titanium. The self- | |
| tapping screws are available in various lengths ranging from 10- | |
| 150 mm. | |
| Intended Use: | The Synthes 3.5 mm Cortex Screws are intended for fixation of |
| fractures, osteotomies and non-unions of the clavicle, scapula, | |
| olecranon, humerus, radius, ulna, pelvis, tibia, calaneous, femur | |
| and fibula. | |
| Substantial | |
| Equivalence: | Information presented supports substantial equivalence. |
:
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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles merging into a single form, resembling a bird in flight.
FEB - 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa M. Boyle Regulatory Specialist Synthes (USA) 1690 Russel Road Paoli, Pennsylvania 19301
Re: K043185
Trade/Device Name: Synthes (USA) 3.5mm Cortex Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: November 16, 2004 Received: November 17, 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 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Lisa M. Boyle
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 (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/industry/support/index.html.
Sincerely yours,
Mark McMillan
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
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Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. There is a horizontal line underneath the word "SYNTHES". The logo and the word are the main focus of the image.
Page 1 of
Indications for Use
510(k) Number (if known):
Device Name:
2.0
Synthes (USA) 3.5 mm Cortex Screws
Indications for Use:
The Synthes 3.5 mm Cortex Screws are intended for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula.
X Prescription Use (Per 21 CFR 801.109)
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
510(k) Number K043185