(22 days)
Not Found
No
The summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology. The device description is not available, but the intended use and predicate device suggest a mechanical tool.
Yes
The device is intended to assist healing of an intraosseous fracture, which is a therapeutic purpose.
No
The S-Bone Hip Tool™ is described as being intended to stabilize a bone graft to assist healing of a fracture, which indicates a therapeutic or surgical function rather than a diagnostic one.
No
The description explicitly states the device is intended to "stabilize a bone graft within the femoral head and neck" and references a predicate device that is an "Implant." This strongly suggests a physical device, not software.
Based on the provided information, the S-Bone Hip Tool™ is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture." This describes a surgical tool used directly on the patient's body to aid in a physical process (bone healing).
- Anatomical Site: The anatomical site is the "femoral head and neck," which is part of the human anatomy, not a sample taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on laboratory tests
- Measuring biomarkers or other biological indicators
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The S-Bone Hip Tool™ is a surgical tool used for mechanical stabilization during a procedure.
N/A
Intended Use / Indications for Use
The S-Bone Hip Tool™ is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.
Product codes
HRS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral head and neck
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
OCT 7 - 2005
510(k) SUMMARY
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Orthopedic Sciences, Inc.
3020 Old Ranch Parkway, Suite 325
Los Angeles, CA 90045 |
|--------------------|-----------------------------------------------------------------------------------------|
| Official Contact: | James K. Brannon. M.D. President/CEO
Telephone (562) 799-5550 Fax (562) 799-5533 |
DEVICE NAME
| Classification Name: | Plate, fixation, bone |
|---|---|
| Trade/Proprietary Name: | S-Bone Hip ToolTM |
| Common Name: | Bone plate |
PREDICATE DEVICE INFORMATION
The predicate device for this modification is the Hip Tool™ Implant, a component of the Hip Tool™ Bone Graft Stabilization System, cleared by FDA on September 23, 2002 under K022139.
INTENDED USE
The S-Bone Hip Tool™ is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract human profiles facing to the right, resembling a bird-like shape.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 7 - 2005
James K. Brannon, M.D. President/CEO Orthopedic Sciences, Inc. 3020 Old Ranch Parkway, Suite 325 Seal Beach, California 90740
Re: K052538 Trade/Device Name: S-Bone Hip Tool™ Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: HRS Dated: September 6, 2005 Received: September 15, 2005
Dear Dr. Brannon:
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- Dr. James K. Brannon
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 (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/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
8-64
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K052538
Device Name: S-Bone Hip Tool™
Indications For Use:
The S-Bone Hip Tool™ is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
$
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_KO52538
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