(85 days)
Howmedica's 4.6mm Fully Threaded Screws, Zimmer's Buttress Thread Screws, Zimmer's ZMS Recon Nail Cross-Locking Screw
Not Found
No
The 510(k) summary describes a mechanical screw for orthopedic use and makes no mention of AI or ML.
No
Explanation: The device is a screw intended for cross-locking intramedullary nails and rods, which are used to stabilize bones. This is a structural component for fixation, not a device that directly treats a disease or condition therapeutically.
No
Explanation: The device description states its intended use is for cross-locking of intramedullary nails and IM rods, which is a structural or fixation purpose, not for diagnosis.
No
The device description clearly states it is a physical screw made of stainless steel, intended for use with intramedullary nails and rods. It is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "crosslocking of Howmedica's intramedullary nails and IM rods." This describes a surgical procedure involving the fixation of bones, not a diagnostic test performed on biological samples outside the body.
- Device Description: The device is a "Fully Threaded Screw" made of stainless steel, designed for mechanical fixation within the body. This is a surgical implant, not a diagnostic reagent or instrument used to analyze biological specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
Therefore, the Howmedica® 3.7mm Fully Threaded Screws are a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Howmedica® 3.7mm Fully Threaded Screws are intended to be used for crosslocking of Howmedica's intramedullary nails and IM rods.
Product codes
87HSB
Device Description
Howmedica's Locking Nail Systems consist of different types of intramedullary nails/rods, cross-locking screws and end caps. This line extension is to add a smaller cross-locking screw for use with current Howmedica® IM rod and nail systems cleared under various 510(k) notifications plus any future styles of stainless steel IM rods or nails. The new screw is 3.7mm in diameter and is available in various lengths. It has a cortical buttress thread design for cross-locking of IM nails. The screws are manufactured from medical grade stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Howmedica's 4.6mm Fully Threaded Screws, Zimmer's Buttress Thread Screws, Zimmer's ZMS Recon Nail Cross-Locking Screw
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
R a 74720
510(k) Summary
MAR 1 3 1998
| Proprietary Name: | Howmedica® Fully Threaded Screws |
|---|---|
| Common Name: | Intramedullary Rod |
| Classification Name & Reference: | Intramedullary Fixation Rod |
| 21 CFR 888.3020 | |
| Proposed Regulatory Class: | II |
| Device Product Code: | 87HSB |
For information contact:
| Vivian Kelly | |
|---|---|
| Manager, Regulatory Affairs | |
| Howmedica Inc. | |
| 359 Veterans Boulevard |
Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7830 Fax: (201) 507-6870
Howmedica's Locking Nail Systems consist of different types of intramedullary nails/rods, cross-locking screws and end caps. This line extension is to add a smaller cross-locking screw for use with current Howmedica® IM rod and nail systems cleared under various 510(k) notifications plus any future styles of stainless steel IM rods or nails. The new screw is 3.7mm in diameter and is available in various lengths. It has a cortical buttress thread design for cross-locking of IM nails. The screws are manufactured from medical grade stainless steel.
The Howmedica® Fully Threaded Screws are intended to be used for cross-locking of intramedullary nails and IM rods.
The substantial equivalence of these components is based on an equivalence in intended use, materials, design, and operational principles to Howmedica's 4.6mm Fully Threaded Screws, Zimmer's Buttress Thread Screws and Zimmer's ZMS Recon Nail Cross-Locking Screw.
1
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 bird-like figure, depicted with stylized lines to represent its wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 1998
Ms. Vivian Kelly Manager, Regulatory Affairs Howmedica, Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
K974720 Re: Howmedica® Fully Threaded Screws Trade Name: II Regulatory Class: Product Code: нав Dated: December 17, 1997 December 18, 1997 Received:
Dear Ms. Kelly:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Vivian Kelly
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K974720 510(k) Number (if known):
Device Name: Howmedica® Fully Threaded Screws
Indications for Use:
The Howmedica® 3.7mm Fully Threaded Screws are intended to be used for crosslocking of Howmedica's intramedullary nails and IM rods.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
bcoòela
Sign-Off)
General Restorative Devices
510(k) number: U974720