(140 days)
Not Found
Not Found
No
The summary describes a surgical screw for bone fixation and does not mention any software, algorithms, or AI/ML terms.
No
The device is described as being for "Fixation and stabilization of bones of the feet," indicating it is an orthopedic implant or surgical tool, which directly interacts with and provides structural support to the body. Therapeutic devices are used to treat or manage a disease or condition, not solely for fixation.
No
The device is described as being for "fixation and stabilization of bones of the feet," indicating a surgical or therapeutic purpose, not a diagnostic one.
No
The intended use describes the fixation and stabilization of bones of the feet using screws, which are physical implants, not software. The summary does not mention any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used in vitro (outside the body).
- This device is used for the fixation and stabilization of bones of the feet. This is a surgical procedure performed in vivo (inside the body).
The description clearly indicates a device used for surgical intervention on the human body, not for laboratory testing of specimens.
N/A
Intended Use / Indications for Use
Fixation and stabilization of bones of the feet; such as: Akin-Osteotomie, Scarf-Osteotomie, Chevron-Austin-Osteotomie, MPG-Arthrodesis, Closing-Wedge Osteotomie. The Scarf screw can be used for the fixation of almost all common osteotomies of the first metatarsal.
Fixation and stabilization of bones of the feet; such as Weil-Osteotomie
Product codes
HWC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones of the feet, first metatarsal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 20 2004
O.M.T. Oberflächen-und Materialtechnologie GmbH C/o Mr. H. Darrel Darby II President Darco International, Inc. 1327 7th Avenue Huntington, West Virginia 25701
Re: K042079
Trade/Device Name: OSS/(Scarf) and OSW Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: November 3, 2004 Received: November 4, 2004
Dear Mr. Darby:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have leviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regard cate of the Medical Device Amendments, or to conninered prior to Tria) 2011-07-11 accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Cosmetic Fer (110) market the device, subject to the general controls provisions of the Act. The I ou may, therefore, mains 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 or 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.
1
Page 2 - Mr. H. Darrel Darby II
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 11 you a the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Ulen Witte
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
2
Indications for Use
510 (k) Number (if known):
Ko42079 KOD2078
OSS/(SCARF)-SCREW
Device Name:
Indications for Use:
Fixation and stabilization of bones of the feet; such as: Akin-Osteotomie, Scarf-Osteotomie, Chevron-Austin-Osteotomie, MPG-Arthrodesis, Closing-Wedge Osteotomie. The Scarf screw can be used for the fixation of almost all common osteotomies of the first metatarsal.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON AN ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Evaluation (ODE)
(Division Sign-Of
Dies
neral, Restori and Neurological Device
510(k) Number K042079
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3
Indications for Use
510 (k) Number (if known):
co42099
Device Name:
Indications for Use:
OSW-SCREW / Twist-Off™ Screw for Weil-Osteotomie
Fixation and stabilization of bones of the feet; such as Weil-Osteotomie
Prescription Use_ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON AN ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Evaluation (ODE)
hy will
koarears
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K042079
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