K Number
K082934
Device Name
EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM
Date Cleared
2009-04-23

(204 days)

Product Code
Regulation Number
888.3040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Extremity Medical Midfoot Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid joints
Device Description
The EXTREMITY MEDICAL Midfoot Screw System
More Information

No
The 510(k) summary describes a mechanical screw system for bone fixation and makes no mention of AI or ML.

Yes
The device is intended for "fixation arthrodesis," which is a medical procedure used to treat specific joints, indicating a therapeutic purpose.

No

Explanation: The device is described as a "Screw System" intended for "fixation arthrodesis," which indicates it is a surgical implant used for treatment (fixation) rather than for diagnosing a condition.

No

The device description clearly indicates a "Midfoot Screw System," which is a hardware implant, 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 the device is for "fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid joints." This describes a surgical procedure performed on the patient's body to stabilize joints.
  • Device Description: The device is described as a "Midfoot Screw System," which is a physical implant used in surgery.
  • Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. The provided information does not mention any such testing or analysis of specimens.

Therefore, the Extremity Medical Midfoot Screw System is a surgical implant, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

"The Extremity Medical Midfoot Screw System is intended for fixation arthrodesis of the metatarsalcuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid 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, and calcaneocuboid 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)

  1. 3.5 Fully Threaded Screw , Synthes K050683
  2. EXTREMITY MEDICAL Compression Screw K081934
  3. Pioneer Medical, Stayfuse K022726
  4. 6.5 Midfoot Fusion Bolt, Synthes K081071

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

K082934 1/1

EXTREMITY

APR 2 3 2009

510k 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 13, 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. 3.5 Fully Threaded Screw , Synthes K050683
2. EXTREMITY MEDICAL Compression Screw K081934
3. Pioneer Medical, Stayfuse K022726
4. 6.5 Midfoot Fusion Bolt, Synthes K081071 |
| 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, and calcaneocuboid 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. |

5

1

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing health, services, and people. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 2009

EXTREMITY MEDICAL LLC % Mr. Jamy Gannoe 300 Interpace Parkway, Suite 410 Parsippany, NJ 07054

Re: K082934

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: April 13, 2009 Received: April 14, 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.

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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at

2

Page 2 - Mr. Jamy Gannoe

(240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours, A

Yor Dhol

กอก

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

3

Image /page/3/Picture/0 description: The image shows the logo for Extremity Medical. The logo features the word "EXTREMITY" in bold, sans-serif font, with a stylized "X" that resembles a person with outstretched arms. Below the word "EXTREMITY" is the word "MEDICAL" in a smaller, less bold font. The logo is simple and modern, and it conveys a sense of strength and innovation.

Indications for Use

510(k) Number (if known): K082934

Device Name:

EXTREMITY MEDICAL Midfoot Screw System

Indications for Use:

"The Extremity Medical Midfoot Screw System is intended for fixation arthrodesis of the metatarsalcuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid joints"

Over-the-counter Prescription Use X AND/OR

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

6

(Division Sign-Off) (Division Digit of General, Restorative, Division - Problem Devices

510(k) Number L682934

б