(133 days)
Not Found
No
The summary describes a mechanical implant and associated tools, with no mention of AI, ML, or any computational analysis of data.
Yes
The device is indicated for "treatment of the hyperpronated foot and stabilization of the subtalar joint," which describes a therapeutic purpose.
No
Explanation: The device is indicated for treatment (blocking displacement and stabilization) of the foot and subtalar joint, not for diagnosing conditions.
No
The device description clearly states the device is a physical implant made of Titanium Alloy, along with associated hardware components like guide wires, screwdrivers, and sizers. This is not a software-only device.
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 treatment of a physical condition (hyperpronated foot and subtalar joint stabilization) by implanting a device. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is a physical implant made of titanium alloy, designed to be placed within the body. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
Therefore, this device falls under the category of a medical device used for treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This submission describes the OsteoMed Subtalar Implant System indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion, but blocking excessive pronation and the resulting sequela. OsteoMed Subtalar Implants are intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The OsteoMed Subtalar Implant System is a spacer for stabilization of the subtalar joint made of Titanium Alloy. The OsteoMed Subtalar implants are offered in diameters of 6.0 to 12.0mm and in lengths of 10.0 to 15.0mm. Guide wires, cannulated screwdrivers and sizers will also be a part of the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subtalar joint
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.
0
Image /page/0/Picture/1 description: The image shows the word "OSTEOMED" in bold, black letters. The word is arched by two curved lines, one above and one below. The lines are also black and bold, creating a frame around the word.
AUG 2 2 2003
510(k) Summary
| Device Proprietary Name: | OsteoMed Subtalar Implant
System |
|--------------------------|----------------------------------------------------------------------------------------------------------------|
| Device Common Name: | Subtalar Implant |
| Classification Name: | Screw, Fixation, Bone |
| Name of Submitter: | OsteoMed L. P.
3885 Arapaho Road
Addison, Texas 75001
Phone: (972) 677-4600
Fax: (972) 677-4601 |
| Contact Person: | Dawn T. Holdeman |
| Date Prepared: | April 7, 2003 |
Summary:
This submission describes the OsteoMed Subtalar Implant System indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion, but blocking excessive pronation and the resulting sequela. OsteoMed Subtalar Implants are intended for single use only.
The OsteoMed Subtalar Implant System is a spacer for stabilization of the subtalar joint made of Titanium Alloy. The OsteoMed Subtalar implants are offered in diameters of 6.0 to 12.0mm and in lengths of 10.0 to 15.0mm. Guide wires, cannulated screwdrivers and sizers will also be a part of the system.
Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Kinetikos Medical Subtalar MBA System (K960692).
Due to the similarity of materials and design to the predicate device, OsteoMed believes that the OsteoMed Subtalar Implant System does not raise any new safety or effectiveness issues.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.
AUG 2 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Ms. Dawn T. Holdeman Regulatory Affairs and Document Control OsteoMed L.P. 3885 Arapaho Road Addison, Texas 75001
Re: K031155
Trade/Device Name: OsteoMed Subtalar Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: April 7, 2003 Received: May 28, 2003
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), please contact the Office of Compliance at (301) 594-4659. 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,
Sincerely yours,
Mark A Milhum
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
OsteoMed "Indications for Use" Submission
| 510(k) Number: | K031155 |
|---|---|
| Device Name: | OsteoMed Subtalar Implant System |
| Indication for Use: | Indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. OsteoMed Subtalar Implants are intended for single use only. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 810.109) $\checkmark$
Over-The Counter-Use (Optical Format 1-)
Mark H Milken
for Division of 33
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number -