(18 days)
Not Found
No
The summary describes a mechanical screw system for bone fixation and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is used for fixation of bones, which is a supportive mechanical function, not a therapeutic treatment.
No
The device is described as a system of screws and instruments for fixation of bones, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is comprised of physical components (screws, screwdrivers, and driver bits), indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixation secondary to trauma or reconstruction of the craniofacial and maxillofacial skeleton and bones of the hand." This describes a surgical implant used directly on the patient's body for structural support.
- Device Description: The description details "1.2mm diameter screws in lengths ranging from 3.0mm to 6.0mm" and "screwdrivers and driver bits." These are physical components used in a surgical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples, while this device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
Indicated for fixation secondary to trauma or reconstruction of the craniofacial and maxillofacial skeleton and bones of the hand. 1.2mm Auto-Drive Screws are intended for single patient use only.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The OsteoMed 1.2mm Auto-Drive Screw System is comprised of 1.2mm diameter screws in lengths ranging from 3.0mm to 6.0mm. System instruments include screwdrivers and driver bits.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial and maxillofacial skeleton and bones of the hand.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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OCT 1 8 2002
KC23360
page 1 of 1
510(k) Summary
Device Proprietary Name: OsteoMed 1.2mm Auto-Drive Screw System
Small Bone Screw Device Common Name:
Classification Name: Screw, Fixation, Bone
Name of Submitter:
- OsteoMed Corporation 3750 Realty Road Addison, Texas 75001 Phone: (972) 241-3401 Fax: (972) 241-3507
Dawn T. Holdeman Contact Person:
September 16, 2002 Date Prepared:
Summary:
This submission describes the OsteoMed 1.2mm Auto-Drive Screw System indicated for fixation secondary to trauma or reconstruction of the craniofacial and maxillofacial skeleton and bones of the hand. 1.2 mm Auto-Drive Screws are intended for single patient use only.
The OsteoMed 1.2mm Auto-Drive Screw System is comprised of 1.2mm diameter screws in lengths ranging from 3.0mm to 6.0mm. System instruments include screwdrivers and driver bits.
Equivalence for this device is based on similarities in intended use, material, design and operational principle to the OsteoMed Auto-Drive Bone Screw (K974785), the Synthes 1.3mm Self-Drilling Screw (K983485), and the Leibinger Self-Drilling Screw (K970912).
Due to the similarity of materials and design to both pre-enactment and postenactment devices. OsteoMed believes that the OsteoMed 1.2mm Auto-Drive Screw System does not raise any new safety or effectiveness issues.
Image /page/0/Picture/17 description: The image shows the logo for OsteoMed Corporation. The logo is in black and white, with the word "OsteoMed" in large, bold letters. Below the word "OsteoMed" is the word "Corporation" in smaller letters. The logo is simple and professional.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
OCT 1 8 2002
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Osteomed Corporation Dawn T. Holdeman Regulatory Affairs and Document Control 3750 Realty Road Addison, Texas 75001-4311
Re: K023260
Trade/Device Name: OsteoMed 1.2mm Auto-Drive Screw System Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 27, 2002 Received: September 30, 2002
Dear Ms. Holdeman:
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.
2
Page 2 -- Ms. Dawn T. Holdeman
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" (21 CFR 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.
Mach N. Mullever
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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K(0.3260
page left
11
OsteoMed "Indications for Use" Submission
:
| 510(k) Number: | K023260 |
|---|---|
| Device Name: | OsteoMed 1.2mm Auto-Drive Screw |
| Indication for Use: | Indicated for fixation secondary to trauma or reconstruction of the craniofacial and maxillofacial skeleton and bones of the hand. 1.2mm Auto-Drive Screws are intended for single patient use only. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 810.109) Over-The Counter-Use (Optical Format 1-)
Mark N. Millman
Theref. Rest ative 510(k) Nurth ir