(56 days)
Not Found
Not Found
No
The 510(k) summary describes a standard mechanical orthopedic implant (cannulated screws) and makes no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device is used for the treatment of bone fractures and for bone reconstructions, which are therapeutic applications.
No.
The device is a surgical implant (cannulated screw system) used for fixation of bone fractures and reconstruction, not for diagnosis.
No
The device description clearly states it is a "Cannulated Screw System" consisting of "multiple sizes of cannulated screws in varying diameters and lengths" made from "316 LVM stainless steel," indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Precimed Cannulated Screw System is a surgical implant used to fix bone fractures and perform bone reconstructions. It is a physical device inserted into the body, not a tool for analyzing biological samples.
The description clearly states its function is to provide "immediate stability and temporary fixation during the natural healing process following fractures," which is a mechanical function within the body, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Precimed Cannulated Screw System is indicated for use in the treatment of bone fractures, such as fractures of the tarsals and metatarsals, and for metatarsal and phalangeal osteotomies and arthrodeses.
Product codes
HWC
Device Description
The Precimed Cannulated Screw System is a Cannulated Screw System used for the fixation of bone fractures and for bone reconstructions. It consists of multiple sizes of cannulated screws in varying diameters and lengths.
Materials: The devices are manufactured from 316 LVM stainless steel per ASTM and ISO standards.
Function: The system functions to provide immediate stability and temporary fixation during the natural healing process following fractures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tarsals and metatarsals, metatarsal and phalangeal
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)
Cannulated Screw System ( S &N Richards ), Cannulated Screw System ( Synthes )
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
MAY 18 2005 K 050754
Summary of Safety and Effectiveness For the Precimed Cannulated Screw System
This safety and effectiveness summary for the Precimed Cannulated Screw System is provided as required per Section 513(i)(1) of the Food, Drug and Cosmetic Act.
- Submitter: 1. Precimed, Inc. 102 Pickering Way, Suite 508
Exton, PA 19341
Contact Person: Barbara Lyons 102 Pickering Way, Suite 508 Exton, PA 19341
March 14, 2005 Date Prepared:
| 2. Tradename: | Precimed Cannulated Screw System |
|---|---|
| Common Name: | Cannulated Screw System |
| Classification Name: | Smooth or threaded metallic bone fixation fastener ( 888.3040 ) |
3. Predicate or legally marketed devices which are substantially equivalent:
- Cannulated Screw System ( S &N Richards ) .
- Cannulated Screw System ( Synthes ) .
4. Description of the device :
The Precimed Cannulated Screw System is a Cannulated Screw System used for the fixation of bone fractures and for bone reconstructions. It consists of multiple sizes of cannulated screws in varying diameters and lengths.
Materials: The devices are manufactured from 316 LVM stainless steel per ASTM and ISO standards.
Function: The system functions to provide immediate stability and temporary fixation during the natural healing process following fractures.
5. Intended Use:
The Precimed Cannulated Screw System is indicated for use in the treatment of bone fractures, such as fractures of the tarsals and metatarsals, and for metatarsal and phalangeal osteotomies and arthrodeses.
-
- Comparison of the technological characteristics of the device to predicate and legally marketed devices :
There are no significant differences between the Precimed Cannulated Screw System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, materials and intended use.
- Comparison of the technological characteristics of the device to predicate and legally marketed devices :
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a stylized image of an eagle. The eagle is represented by four curved lines, suggesting its wings and body. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 8 2005
Ms. Barbara Lyons Precimed Incorporated 102 Pickering Way, Suite 508 Exton, Pennsylvania 19341
Re: K050754
Trade/Device Name: Precimed Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 14, 2005 Received: March 23, 2005
Dear Ms. Lyons:
We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave ro rowed your 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 r ou mayy are se revisions 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 your de 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 or unf I 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. Barbara Lyons
This letter will allow you to begin marketing your device as described in your Section 510(k) This icher will anow you to begin maing of substantial equivalence of your device to a legally premation fouried.com "re 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 If you desire specific advice 10. Jour at (240) 276-0120 . Also, please note the regulation entitled, Connact and office of Company to premarket notification" (21CFR Part 807.97). You may obtain Misoraliums by reference to premiento willities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
A. Hipt. Rlwdw
2 Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: Precimed Cannulated Screw System
Indications for Use:
The Precimed Cannulated Screw System is indicated for use in the treatment of bone fractures, such as fractures of the tarsals and metatarsals, and for metatarsal and phalangeal osteotomies and arthrodeses.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS-LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division
Division of General Restorative, and Neurological Devices
510(k) Number K050754