(87 days)
Synthes 4.0 and 5.0mm Locking Screws
Not Found
No
The device description focuses solely on the physical characteristics and materials of the locking screws, with no mention of software, algorithms, or data processing.
No.
The device description indicates that the screws are used for interlocking intramedullary femoral and tibial nails, which are used to stabilize bones. While this helps in the healing process, the screws themselves are structural components, not devices that directly treat a disease or condition through therapeutic action.
No
Explanation: The device description clearly states that Magly 4.0 and 5.5mm Locking screws are "used for the interlocking of APEX Intramedullary Femoral and Tibial Nails," indicating a structural or supportive function rather than a diagnostic one. There is no mention of analysis, measurement, or identification of medical conditions.
No
The device description clearly states that the device is a physical locking screw made from titanium alloy, used for interlocking intramedullary nails. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that these are "Locking screws" used for "interlocking of APEX Intramedullary Femoral and Tibial Nails." These are implantable devices used in orthopedic surgery.
- Intended Use: The intended use is for surgical fixation within the body, not for testing biological samples.
Therefore, based on the provided information, the Magly 4.0 and 5.5mm Locking screws are not IVDs. They are surgical implants.
N/A
Intended Use / Indications for Use
Magly 4.0 and 5.5mm Locking screws are used for the interlocking of APEX Intramedullary Femoral and Tibial Nails.
Product codes
HWC
Device Description
The screws are fully threaded from the distal tip to approximately 1mm to 2mm under the head. The distal end will embody a spherical shape at the tip and four cutting flutes used for tapping the thread profile.
The locking screws will be available in 2mm incremental lengths, measured from under the head to the distal tip, the 4.0mm from 16mm-80mm and the 5.5mm from 20mm-120mm.
Magly 4.0 and 5.5mm Locking Screws are manufactured from titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral, Tibial
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Synthes 4.0 and 5.0mm Locking Screws
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
AUG 0 9 2002
K021579
page 1 of 1
510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS Magly 4.0 and 5.5mm Locking Screws
Submission Information Name and Address of the Sponsor Of the 510(k) Submission: Magly Orthopedics, LLC 14241 NE Woodinville-Duvall Road, #415 Woodinville, Washington 98072 425.489.2057 Phone 425.482.0147 Fax Contact Person: Dave Stinson Date Summary Prepared: April 9, 2002 Device Identification Magly 4.0 and 5.5mm Locking Screws Proprietary Name: 4.0mm Locking Screw, Fully Threaded Common Name: 5.5mm Locking Screw, Fully Threaded Classification: Screw, Fixation, Bone 21 CFR §888.3040
Predicate Device Identification
The Magly 4.0 and 5.5mm Locking Screws are substantially equivalent to that of the predicate Synthes 4.0 and 5.0mm Locking Screws. The Magly 4.0 and 5.5mm Locking Screws are similar to the listed predicate device in design, function, materials used, and indications for use.
Device Description
The screws are fully threaded from the distal tip to approximately 1mm to 2mm under the head. The distal end will embody a spherical shape at the tip and four cutting flutes used for tapping the thread profile.
The locking screws will be available in 2mm incremental lengths, measured from under the head to the distal tip, the 4.0mm from 16mm-80mm and the 5.5mm from 20mm-120mm.
Magly 4.0 and 5.5mm Locking Screws are manufactured from titanium alloy.
Intended Use of the Device
Magly 4.0 and 5.5mm Locking screws are used for the interlocking of APEX Intramedullary Femoral and Tibial Nails.
Magly Orthopedics, LLC Magly 4.0 and 5.5mm Locking Screws 18
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines above them that resemble a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 0 9 2002
Mr. Dave Stinson Partner Magly Orthopedics, LLC 14241 NE Woodinville-Duvall Road, #415 Woodinville, Washington 98072
Re: K021579
Trade/Device Name: Magly 4.0 and 5.5mm Locking Screws Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: April 12, 2002 Received: May 14, 2002
Dear Mr. Stinson:
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 such 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.
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Page 2 -- Mr. Dave Stinson
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours
Sincerely yours,
Mark McMillan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Statement of Indications for Use
Page 1 of 1
510(k) Number:
021579
Device Name:
Magly 4.0 and 5.5mm Locking_Screws
Indication(s) for Use:
- · Magly 4.0 and 5.5mm Locking screws are used for the interlocking of APEX Intramedullary Femoral and Tibial Nails
(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)
Over-the-Co
Over-the-Counter Use __
Mark A. Milliken
OR
(Optional Format 1-2-96)
Division of General. Restorative and Neurological Devices
510(k) Number K021574
Magly Orthopedics, LLC Magly 4.0 and 5.5mm Locking Screws 12