(141 days)
Not Found
No
The description focuses on mechanical components and surgical technique, with no mention of AI/ML terms or image processing. Performance studies are bench and cadaveric, not involving data analysis typical of AI/ML.
No
The device is described as a "screw system" intended for "fixation arthrodesis" of joints, which indicates it is an implant used for structural support and stabilization, not a device that directly administers therapy.
No
The provided text describes a screw system intended for fixation in joint fusion (arthrodesis), not for diagnosing a medical condition.
No
The device description explicitly states it consists of "two metallic components" and "common instrumentation for the application of surgical bone screws," indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Extremity Medical Screw System is a metallic implant intended for surgical fixation of specific joints in the foot and hand. This is a surgical device used in vivo (within the living body), not a test performed in vitro (in a lab setting).
The information provided describes a surgical implant and its intended use in orthopedic procedures, which falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Extremity Medical Screw System is intended for fixation arthrodesis of the metatarsalcuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid, metatarsalphalangeal and metacarpal-phalangeal joints.
Product codes
HWC
Device Description
The EXTREMITY MEDICAL Screw System consists of two metallic components a Metacarpal (distal) screw and a Lag Screw (proximal). The two components are designed to rigidly lock together to form an angle between the two components. The system includes common instrumentation for the application of surgical bone screws.
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, metatarsal-phalangeal and metacarpal-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
Bench testing including pull-out strength and torque was performed and compared to the predicate devices. Clinical simulations in cadavers were performed to verify the surgical technique. No clinical testing was performed
Key Metrics
Not Found
Predicate Device(s)
Extremity Medical K082934, Extremity Medical K091577, K962823
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
/ z
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------!
Image /page/0/Picture/2 description: The image shows the logo for Extremity Medical. The logo features the word "EXTREMITY" in bold, black letters, with a stylized figure forming the "X". Below "EXTREMITY" is the word "MEDICAL" in a smaller font.
510(k) Summary of Safety and Effectiveness: .
EXTREMITY MEDICAL Implant System
| 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 | April 22, 2010 |
| Trade Name | EXTREMITY MEDICAL 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, Extremity Medical K082934
2. EXTREMITY MEDICAL Midfoot Screw System, Extremity Medical K091577
3. 3.0 Cannulated Screw and Threaded Washer, Synthes K962823 |
| Device Description | The EXTREMITY MEDICAL Screw System consists of two metallic components a Metacarpal (distal) screw and a Lag Screw (proximal). The two components are designed to rigidly lock together to form an angle between the two components. The system includes common instrumentation for the application of surgical bone screws. |
| Indications for use | The Extremity Medical Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid, metatarsal-phalangeal and metacarpal-phalangeal joints. |
| Statement of
Technological
Comparison | The EXTREMITY MEDICAL 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. |
| Nonclinical Testing | Bench testing including pull-out strength and torque was performed and
compared to the predicate devices. Clinical simulations in cadavers were
performed to verify the surgical technique. |
| Clinical Testing | No clinical testing was performed |
| Conclusion | The EXTREMITY MEDICAL 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. |
i l
1
Image /page/1/Picture/0 description: The image shows the logo for Extremity Medical. The logo features the word "EXTREMITY" in bold, black letters, with a stylized figure forming the "X". Below "EXTREMITY" is the word "MEDICAL" in smaller, black letters. The logo is simple and professional, conveying a sense of expertise and reliability.
72
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. 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 symbol resembling an eagle or bird in flight, composed of three curved lines representing the head, body, and tail feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
APR 2 8 2010
Extremity Medical, LLC % Mr. Jamy Gannoe 300 Interpace Parkway, Suite 410 Parsippany, NJ 07054
Re: K093770
Trade/Device Name: Extremity Medical 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 1, 2010 Received: April 23, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 (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.
3
Page 2 - Mr. Jamy Gannoe
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Barbara Brent
Mark N. Melkerson Director Division of Surgical, Orthopedić and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): Device Name: Indications for Use:
K093770 EXTREMITY MEDICAL Screw System
The Extremity Medical Screw System is intended for fixation arthrodesis of the metatarsalcuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid, metatarsalphalangeal and metacarpal-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)
Smute for mxm
(DWision Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093770