(53 days)
No
The summary describes a mechanical orthopedic implant (a screw) and contains no mention of software, algorithms, image processing, or AI/ML terms.
Yes
The device is described as an "internal fixation" device for fractures and nonunions, which directly aids in the healing process of physical ailments.
No
Explanation: This device is an orthopedic screw used for internal fixation, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states "The EXTREMITY MEDICAL Compression Screw," which is a physical implantable device used for internal fixation. This is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (a compression screw) used for the internal fixation of bones and joints. This is a device used within the body for structural support and healing, not for testing samples outside the body.
The information provided aligns with a Class II or Class III medical device used in surgery, not an IVD.
N/A
Intended Use / Indications for Use
The Extremity Medical Compression Screw is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures and nonunions of the small bones and joints of the foot and hand. Examples include scaphoid fractures, tarsal and metatarsal fracture, hand, wrist, foot and ankle arthrodeses, metacarpal and metatarsal arthrodeses, distal radius fractures.
Product codes
HWC
Device Description
The EXTREMITY MEDICAL Compression Screw
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones and joints of the foot and hand, scaphoid, tarsal, metatarsal, hand, wrist, foot, ankle, metacarpal, distal radius
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
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:
AUG 2 9 2008
EXTREMITY MEDICAL Implant System
| Submitter: | EXTREMITY MEDICAL LLC
300 Interpace Parkway
Suite 410
Parsippany, NJ 07054 |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Jamy Gannoe
President
Phone: 973-316-9900
Email: jgannoe@extremitymedical.com |
| Date Prepared | August 15, 2008 |
| Trade Name | EXTREMITY MEDICAL Compression Screw |
| Classification Name
and Number | Smooth or threaded metallic bone fixation fastener
21 CFR 888.3040 |
| Product Code | HWC |
| Predicate Devices | 1. Synthes, Compression Screw K050636
2. Newdeal, I.CO.S K993762
3. Kinetikos Medical, Inc., Kompressor K024233 |
| Device Description | The EXTREMITY MEDICAL Compression Screw |
| Indications for use | The Extremity Medical Compression Screw is intended for
reduction and internal fixation of arthrodeses, osteotomies,
intra- and extra-articular fractures and nonunions of the small
bones and joints of the foot and hand. Examples include
scaphoid fractures, tarsal and metatarsal fracture, hand, wrist,
foot and ankle arthrodeses, metacarpal and metatarsal
arthrodeses, distal radius fractures. |
| Statement of
Technological
Comparison | The EXTREMITY MEDICAL Compression Screw and its
predicate devices have the same indications for use have a
similar design and are made of the similar materials. |
| Conclusion | The EXTREMITY MEDICAL Compression Screw is
substantially equivalent to its predicate devices. This
conclusion is based upon the fact that this device is substantially
equivalent in terms of indications for use, materials, design and
principles of operation. |
1
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:
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the department's name around the perimeter. In the center of the seal is a stylized image of an abstract human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 9 2008
Extremity Medical LLC % Mr. Jamy Gannoe President 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054
Re: K081934
Trade/Device Name: EXTREMITY MEDICAL Compression Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: July 2, 2008 Received: July 7, 2008
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 (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); 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
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Mulhusan
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Premarket Notification
Screw
Indications for Use
| 510(k) Number (if known): | |
|---|---|
| Device Name: | EXTREMITY MEDICAL Compression |
| Indications for Use: |
The Extremity Medical Compression Screw is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures and nonunions of the small bones and joints of the foot and hand. Examples include scaphoid fractures, tarsal and metatarsal fracture, hand, wrist, foot and ankle arthrodeses, metacarpal and metatarsal arthrodeses, distal radius fractures.
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)
Mark M. Mikkelsen
and I
510(k) Number