(112 days)
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Not Found
No
The summary describes a mechanical device for fracture fixation and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is described as "internal fracture fixation of small and large bones," which indicates a therapeutic purpose.
No
This device is for internal fracture fixation, which is a therapeutic purpose, not a diagnostic one. It is a surgical implant designed to treat fractures, not to identify or diagnose medical conditions.
No
The intended use clearly describes a device for internal fracture fixation using screws, which are physical hardware components. There is no mention of software as the primary or sole 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 "internal fracture fixation of small and large bones." This describes a surgical implant used within the body to stabilize fractures.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
The device described is a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The device is intended to be used for internal fracture fixation of small and large bones. It is to be used in combination with 3.5mm diameter and 4.5 mm diameter stainless steel cortical bone screws.
It is not intended for use in the attachment of screws or other devices to the posterior elements of the cervical, thoracic or lumbar spine.
Product codes
HWC
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Small and large bones (excluding posterior elements of the cervical, thoracic or lumbar spine)
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains 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 three curved lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jun 2 1 2004
Barry T. Bickley, M.D. President Simplicity Orthopedic Solutions, LLC. 15 Woodbury Lane North Andover, MA 01845
Re: K032966
Trade/Device Name: The Answer Screw Supplementation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: December 16, 2003 Received: December 17, 2003
Dear Dr. Bickley:
This letter corrects our substantially equivalent letter of January 13, 2004, regarding The Answer Screw Supplementation System, which incorrectly listed the sponsor of your 510(k) premarket notification as Amco Precision Tool, Inc.
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, DIUg, 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 of ecting 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
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Page 2 - Dr. Barry T. Bickley
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 100-1150.
This letter will allow you to continue 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 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 devise, please contact the Office of Compliance at (301) 594-4639. Other general information on your device responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmandsmam.html.
Sincerely yours,
L. Mark A. Milhurn
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
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Page __ of _1
510(k) Number: K032966
Device Name: The Answer Screw Supplementation System
Indications For Use:
The device is intended to be used for internal fracture fixation of small and large bones. It is to be used in combination with 3.5mm diameter and 4.5 mm diameter stainless steel cortical bone screws.
It is not intended for use in the attachment of screws or other devices to the posterior elements of the cervical, thoracic or lumbar spine.
for Mark N. Milkem
Division Sig
Division of G : Restorative
and Neurolog Devices
-) Numt:
(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)
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