(243 days)
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Not Found
No
The provided 510(k) summary describes a system of implants for bone fixation and reconstruction, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is indicated for fixation of bone fractures and bone reconstruction, which are therapeutic interventions.
No
The device is described as an implant for fixing bone fractures and reconstruction, which is a therapeutic function, not a diagnostic one.
No
The intended use clearly describes "implants," which are physical devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of bone fractures and for bone reconstruction in the hand and forefoot surgery." This describes a surgical implant used directly on the patient's body for structural support and repair.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
The device described is a surgical implant, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The implants of the Foot and Hand Motion System are indicated for the fixation of bone fractures and for bone reconstruction in the hand and forefoot surgery.
Product codes
HWC, JDR
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
hand and forefoot
Indicated Patient Age Range
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Intended User / Care Setting
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Newclip Technics % The OrthoMedix Group, Inc. % Mr. J.D. Webb 1001 Oakwood Blvd. Round Rock, TX 78681
DEC 1 6 2009
Re: K091118
Trade/Device Name: Newclip Foot and Hand Motion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, JDR Dated: November 18, 2009 Received: November 24, 2009
Dear Mr. Webb:
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.
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Page 2 - Mr. J.D. Webb
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jucta 75
Image /page/1/Picture/5 description: The image contains a handwritten symbol or character that appears to be a combination of cursive letters or a stylized design. It features a loop at the top, extending into a downward stroke that curves back up at the bottom. The character is drawn in black ink or a dark color against a white background, suggesting it could be part of a signature, logo, or unique script.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for NewClip Technologies. The word "NEWCLIP" is in large, bold, sans-serif font. Below that, the word "TECHNOLOGIES" is in a smaller, sans-serif font. Above and to the right of "NEWCLIP" is a curved line that resembles a satellite dish.
3. INDICATIONS FOR USE
510(k) Number (if known): KO9 \ \ \ \ {
Device Name: Foot and Hand Motion System
Indications for Use:
The implants of the Foot and Hand Motion System are indicated for the fixation of bone fractures and for bone reconstruction in the hand and forefoot surgery.
Prescription Use AND/OR Part 21 CFR 801 Subpart D)
Over-The-Counter Use ____________
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Smuta for nxn
(Division Sign)
(Division Sign Off) Division of Surgical, Ofthopedic, and Restorative Devices
510(k) Number K091118
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