(46 days)
Not Found
Not Found
No
The description focuses on mechanical components (plates, screws) and their intended use in fracture fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a plating system intended for fractures and non-unions of the proximal humerus, not for therapy or treatment of disease.
No
Explanation: The device description states its purpose is to treat fractures, osteotomies, and non-unions of the proximal humerus, not to diagnose them. It consists of bone plates and screws which are therapeutic implants.
No
The device description explicitly states it consists of bone plates and locking screws made of a titanium alloy, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Orthofix Titanium Humeral Plating System is described as a system of bone plates and screws made of titanium alloy, intended for surgical fixation of fractures, osteotomies, and non-unions of the proximal humerus. This is a surgical implant used within the body, not a device for testing samples outside the body.
- Intended Use: The intended use is for treating bone fractures and related conditions, which is a surgical intervention, not a diagnostic test.
Therefore, the Orthofix Titanium Humeral Plating System falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Orthofix Titanium Humeral Plating System is intended for fractures, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone.
Product codes (comma separated list FDA assigned to the subject device)
KTW
Device Description
The Orthofix Titanium Humeral Plating System consists of bone plates and locking screws, made of a titanium alloy. The bone plate included in the system is designed to treat fractures of the proximal humerus and come in a right and left version.
The plate has several locking options for the insertion of Fragment Fixations System implants (FFS), thus allowing a customized fragment adapted approach. Accessories include a cover to protect the ends of the FFS and a screw to lock this cover on the plate.
Instrumentation is available for the insertion of the plates and screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal humerus
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.
Not Found
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
§ 888.3030 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
510(k) Summary of Safety and Effectiveness
Orthofix Titanium Humeral Plating System "LSP"
510(k) K062920
NOV 1 3 2006
- General Information: 1.
| Proprietary Name | Orthofix Titanium Humeral Plating System "LSP" |
|---|---|
| Common Name | Bone plate |
| Regulatory Class | II |
| Device Classification | 87 KTW (21 CFR 888.3030) |
| Registration number | 9680825 |
| Contact Person | Rolando Stanghellini |
| Via delle Nazioni 9 | |
| 37012 Bussolengo (VR) | |
| Italy | |
| Summary Preparation Date | September 22nd, 2006 |
2. Description
The Orthofix Titanium Humeral Plating System consists of bone plates and locking screws, made of a titanium alloy. The bone plate included in the system is designed to treat fractures of the proximal humerus and come in a right and left version.
The plate has several locking options for the insertion of Fragment Fixations System implants (FFS), thus allowing a customized fragment adapted approach. Accessories include a cover to protect the ends of the FFS and a screw to lock this cover on the plate.
Instrumentation is available for the insertion of the plates and screws.
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3. Intended Use
The Orthofix Titanium Humeral Plating System is intended for fractures, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone.
4. Substantial equivalence
Documentation is provided which demonstrates the Orthofix Titanium Humeral Plating System to be substantially equivalent to another legally marketed device. The plates included in the Orthofix Titanium Humeral Plating System and the predicate device, are both metallic bone fixation systems as defined in 21 CFR 888.3030, furthermore, the size, shape and materials for the subject devices are comparable to the predicate devices.
5. Conclusion
Based upon the similarities in design, materials and intended uses of the subject and predicate device, it is concluded that the Orthofix Titanium Humeral Plating System is substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle, emphasizing the department's name and national affiliation. The logo is presented in black and white, giving it a formal and official appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Orthofix SRL % Ms. Candace F. Cederman 15058 Armel Drive Oregon City, Oregon 97045
NOV 1 3 2006
Re: K062920
Trade/Device Name: Orthofix Titanium Humeral Plating System "LSP" Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories. Regulatory Class: II Product Code: KTW Dated: September 27, 2006 Received: September 28, 2006
Dear Ms. Cederman:
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. Candace F. Cederman
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Jaubaya Buckup
for
Mark N. Melkerson 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 (if known):
Device Name:
Orthofix Titanium Humeral Plating System
Indications for Use:
The Orthofix Titanium Humeral Plating System is intended for fractures, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
loubene Buchurd Benson
(Division: On-Off) Division of Ceneral, Restorative, and Neurological Devices
510(k) Number K062120
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