(52 days)
Not Found
No
The summary describes a mechanical screw system for joint fixation and contains no mention of AI, ML, image processing, or performance metrics typically associated with AI/ML devices.
No
The device is described as a "System" intended for "fixation arthrodesis," which indicates it is a medical device used in surgery to fuse bones, not for therapy or treatment.
No
Explanation: The device is intended for fixation arthrodesis of joints, which is a treatment procedure, not a diagnostic one.
No
The device description and intended use clearly indicate a physical screw system for fixation, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fixation arthrodesis of various joints in the foot." This describes a surgical procedure performed directly on the patient's body to stabilize joints.
- Device Description: The device is a "Midfoot Screw System," which are implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to be implanted within the body for structural support or fixation.
N/A
Intended Use / Indications for Use
The Extremity Medical Midfoot Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid, and metatarsal-phalangeal joints.
Product codes
HWC
Device Description
The EXTREMITY MEDICAL Midfoot Screw System
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid, and metatarsal-phalangeal joints.
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)
Reference Device(s)
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
510(k) Premarket Notification
510(k) Summary of Safety and Effectiveness:
1JUL 2 4 7099
| Submitter: | EXTREMITY MEDICAL LLC
300 Interpace Parkway
Suite 410
Parsippany, NJ 07054 |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Jamy Gannoe
President
Phone: (973) 588-8980
Email: jgannoe@extremitymedical.com |
| Date Prepared | May 28, 2009 |
| Trade Name | EXTREMITY MEDICAL Midfoot Screw System |
| Classification Name
and Number | Smooth or threaded metallic bone fixation fastener
21 CFR 888.3040 |
| Product Code | HWC |
| Predicate Devices | 1. EXTREMITY MEDICAL Midfoot Screw System K082934
2. 3.5 Fully Threaded Screw, Synthes K050683 |
| Device Description | The EXTREMITY MEDICAL Midfoot Screw System |
| Indications for use | The Extremity Medical Midfoot Screw System is intended for
fixation arthrodesis of the metatarsal-cuneiform, navicular-
cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid,
and metatarsal-phalangeal joints. |
| Statement of
Technological
Comparison | The EXTREMITY MEDICAL Midfoot Screw System and its
predicate devices have the same indications for use; have a
similar design; are made of similar materials, and have
equivalent mechanical properties. |
| Conclusion | The EXTREMITY MEDICAL Midfoot Screw System is
substantially equivalent to its predicate devices. This
conclusion is based upon indications for use, materials, design,
test data and principles of operation. |
EXTREMITY MEDICAL Implant System
ഗ്ര
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure, with its wings spread and head turned to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EXTREMITY MEDICAL LLC % Mr. Jamy Gannoe 300 Interpace Parkway, Suite 410 Parsippany, NJ 07054
Re: K091577
Trade/Device Name: EXTREMITY MEDICAL Midfoot Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 28, 2009 Received: June 2, 2009
Dear Mr. Gannoe:
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.
(JUL 2 4 2009
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's
2
Page 2 - Mr. Jamy Gannoe
(CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buehup
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Premarket Notification
Indications for Use
510(k) Number (if known): Device Name:
Indications for Use:
ר KO4 1577 EXTREMITY MEDICAL Midfoot Screw System
The Extremity Medical Midfoot Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid, and metatarsal-phalangeal joints.
Prescription Use X_ AND/OR Over-the-counter (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ooutta for mxm
(Division Sign. Oth
Surgical, Orthopedic, and Restorative Devices
510(k) Number K091577