(133 days)
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.
The provided documents (K031155) pertain to a 510(k) premarket notification for a medical device: the "OsteoMed Subtalar Implant System." This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and performance metrics for a novel technology, especially one involving AI or image analysis.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not available in the provided document.
The 510(k) summary explicitly states that equivalence for this device is based on similarities in intended use, material, design, and operational principle to a predicate device (Kinetikos Medical Subtalar MBA System, K960692). This type of submission does not typically include a clinical study with performance metrics in the way your request describes for a diagnostic or AI-based device.
Key points from the document relevant to its submission type:
- Device Type: Subtalar Implant System (a physical orthopedic implant).
- Purpose of Submission: To establish substantial equivalence to a legally marketed predicate device.
- Basis for Equivalence: Similarities in intended use, material (Titanium Alloy), design, and operational principle to the Kinetikos Medical Subtalar MBA System (K960692).
- Claim: "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."
In summary, none of the requested information regarding acceptance criteria and a study proving device performance in the context of diagnostic or AI device evaluations can be extracted from K031155 because it is a submission for a physical implant based on substantial equivalence, not a performance study for software or a new diagnostic method.
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AUG 2 2 2003
510(k) Summary
| Device Proprietary Name: | OsteoMed Subtalar ImplantSystem |
|---|---|
| Device Common Name: | Subtalar Implant |
| Classification Name: | Screw, Fixation, Bone |
| Name of Submitter: | OsteoMed L. P.3885 Arapaho RoadAddison, Texas 75001Phone: (972) 677-4600Fax: (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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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
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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 -
§ 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.