(31 days)
None
No
The summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device description is also not available, and the intended use is purely mechanical stabilization.
Yes
The device is intended to assist healing of a fracture, which is a therapeutic function.
No
The device is intended to stabilize a bone graft to assist healing, which is a therapeutic function, not a diagnostic one.
No
The intended use describes a physical device ("Titanium-Hip Tool™ is intended to stabilize a bone graft within the femoral head and neck"). The predicate device is also an "Implant," indicating a hardware component. There is no mention of software as the primary or sole component.
Based on the provided information, the Titanium-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 treat a physical condition.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: The description doesn't mention analyzing any biological samples or providing diagnostic information based on such analysis.
Therefore, the Titanium-Hip Tool™ falls under the category of a surgical or orthopedic device, not an IVD.
N/A
Intended Use / Indications for Use
The Titanium-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
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)
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
05/032 Titanium-Hip ToolTM
MAY 2 3 2005
510(k) SUMMARY
Telephone (310) 242-6643 FAX (310) 242-6603
ﻴ
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Orthopedic Sciences,
Inc. 6080 Center Drive,
Sixth Floor Los
Angeles, CA 90045 |
|--------------------|-----------------------------------------------------------------------------------------|
| Official Contact: | James K. Brannon. M.D. President/CEO |
DEVICE NAME
| Classification Name: | Plate, fixation, bone |
|---|---|
| Trade/Proprietary Name: | Titanium-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 Titanium-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 seal of the Department of Health and Human Services, USA. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three abstract human profiles facing right, with three horizontal lines above them, representing the department's mission to promote health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2005
James K. Brannon, M.D. President/CEO Orthopedic Sciences Incorporated 6080 Center Drive 6th Floor Los Angeles, California 90045
Re: K051032
Trade/Device Name: Titanium-Hip Tool™ Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: January 15, 2005 Received: April 22, 2005
Dear Dr. Brannon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have leviewed your bootical be (~) f
above and have determined the device is substantially equivalent (for the indications for use stated in above and have actegally marketed predicate devices marketed in interstate commerce prior 10 the cholosare) to regary mannent date of the Medical Device Amendments, or to devices that have been May 20, 1770, the elabilities 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 do not require approvisions of the Act. The general controls provisions of the Act device, subject to the general 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 If your device is classified (socures). Existing major regulations affecting your device can be found in oc subject to back at 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 I tease of a rised a determination that your device complies with other requirements of the Act or any I DA has made a acterninations administered by other Federal agencies. You must comply with all the I care statues and registering but not limited to: registration and listing (21 CFR Part 807); labeling Act 3 requirements, moramer cartice requirements as set forth in the quality systems (QS) (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 -James K Brannon, M.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w Jourse of substantial equivalence of your device to a legally prematicated predicated. - 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 If you dosire 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, Echernational 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,
Muriam C Provost
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number: K051032
Device Name: Titanium-Hip Tool™
Indications For Use:
The Titanium-Hip Tool™ is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.
Prescription Use X (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)
Muriam C. Provozt
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_K051032
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