(160 days)
No
The description focuses on the mechanical design and materials of a modular intramedullary rod system for bone fixation. There is no mention of AI, ML, image processing, or data-driven algorithms for diagnosis, treatment planning, or device operation.
Yes
The device is intended for the "management of segmental diaphyseal bone loss of the femur in oncology patients secondary to radical bone loss and/or resection due to tumors," which directly addresses a disease state and aims to restore function, classifying it as a therapeutic device.
No
The device is a system of modular intramedullary rod segments intended to be used in the management of segmental diaphyseal bone loss of the femur. It is aifixation device, not a diagnostic one.
No
The device description clearly outlines a system of modular intramedullary rod segments, attachment shells, screws, and other physical components made of titanium alloy. There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "management of segmental diaphyseal bone loss of the femur in oncology patients secondary to radical bone loss and/or resection due to tumors." This describes a surgical implant used to fix bone defects.
- Device Description: The description details a system of "modular intramedullary rod segments" and "attachment shells" made of titanium alloy. This is consistent with a surgical implant for bone fixation.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with bodily specimens in this way.
- Performance Studies: The performance studies mentioned are mechanical and functional testing, which are relevant for a structural implant, not an IVD.
The device described is a surgical implant used to stabilize and fix bone defects.
N/A
Intended Use / Indications for Use
The device is intended to be used in the management of segmental diaphyseal bone loss of the femur in oncology patients secondary to radical bone loss and/or resection due to tumors. The intramedullary rods can be fixed with interlocking screws without or with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The OsteoBridge™ IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System is a series of modular intramedullary rod segments that may be used as either proximal or distal segments. The segments are designed to be attached together to form a complete intramedullary rod using semicircular hollow attachment shells that are clamped together with multiple screws to create a complete intramedullary rod. The complete unit is designed to accept interlocking bone screws for additional rotational stability.
The implants from this submission are an extension of the OsteoBridge™ IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System (K051965/K113303). The components from this submission can be used in combination with the rod segments from the OsteoBridge™ IDSF diameter 10 to 16 mm (K051965) as well as with the dia. 5 mm interlocking screws. In addition sterile intramedullary rod segments are available in diameters of 18 mm and 20 mm in lengths of 90 mm and 110 mm. The hollow central attachment shell for use in the femur has a diameter of 34 mm and is available in four lengths 40 mm, 50 mm, 60 mm and 70 mm with reducing bushings to allow the use of different diameter rods proximally and distally to better fit the medullary canal. If the defect size is larger than 70 mm, two attachment shells can be connected by a spacer connector.
All components of the OsteoBridge™ IDSF system are manufactured from Ti-6Al-4V titanium alloy conforming to ASTM F 136-13.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur
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)
Non-Clinical Performance Data:
In order to demonstrate that the OsteoBridge™ IDSF has the mechanical properties necessary to perform its intended use, and that the device performs as well as or better than the predicate device. Merete has conducted mechanical and functional testing (according to ASTM F-1264-03). The tests represent the worst case scenario for the strength of the system. All products have successfully passed all tests. The OsteoBridge™ IDSF system has hereby been proven to be mechanically safe.
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.
K051965 – OsteoBridge™ IDSF Intramedullary Diaphyseal Segmental Defect Fixation System, K113303 - OsteoBridge™ IDSF Intramedullary Diaphyseal Segmental Defect Fixation System
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2015
Merete Medical GmbH % Mr. Rüdiger Hilken Merete Medical, Incorporated 4 Crotty Lane, Suite 118, New York International Plaza New Windsor, New York 12553
Re: K142451
Trade/Device Name: OsteoBridge™ IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System
Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: January 6, 2015 Received: January 13, 2015
Dear Mr. Hilken:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
Page 2 - Mr. Rüdiger Hilken
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
1. Indications for Use Statement
Indications for Use
510(k) Number (if known): K142451
Device Name: OsteoBridge™ IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System
Indications for Use:
The device is intended to be used in the management of segmental diaphyseal bone loss of the femur in oncology patients secondary to radical bone loss and/or resection due to tumors. The intramedullary rods can be fixed with interlocking screws without or with bone cement.
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)
3
2. 510(k) Summary of Safety and Effectiveness Information
| Date Prepared: | August 2014 |
|---|---|
| Submitted by: | Merete Medical GmbH |
| Alt-Lankwitz 102 | |
| 12247 Berlin, Germany | |
| FDA Registration Number: | 3002949614 |
| Contact Person: | Rüdiger Hilken |
| Merete Medical, Inc. | |
| 4 Crotty Lane – Suite 118 | |
| New York International Plaza | |
| New Windsor, NY 12553 | |
| Phone: 914 967 1532 | |
| Device Name: | OsteoBridge™ IDSF - Intramedullary Diaphyseal Segmental |
| Defect Fixation Rod System | |
| Common Name: | Intramedullary Fixation System |
| Classification Names: | Intramedullary fixation rod |
| (21 CFR 888.3020) | |
| Product Code: | HSB |
| Proposed Regulatory Class: | Class II |
| Predicate Devices: | K051965 – OsteoBridge™ IDSF Intramedullary Diaphyseal |
| Segmental Defect Fixation System | |
| K113303 - OsteoBridge™ IDSF Intramedullary Diaphyseal | |
| Segmental Defect Fixation System |
Device Description:
The OsteoBridge™ IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System is a series of modular intramedullary rod segments that may be used as either proximal or distal segments. The segments are designed to be attached together to form a complete intramedullary rod using semicircular hollow attachment shells that are clamped together with multiple screws to create a complete intramedullary rod. The complete unit is designed to accept interlocking bone screws for additional rotational stability.
The implants from this submission are an extension of the OsteoBridge™ IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System (K051965/K113303). The components from this submission can be used in combination with the rod segments from the OsteoBridge™ IDSF diameter 10 to 16 mm (K051965) as well as with the dia. 5 mm interlocking screws. In addition sterile intramedullary rod segments are available in diameters of 18 mm
4
and 20 mm in lengths of 90 mm and 110 mm. The hollow central attachment shell for use in the femur has a diameter of 34 mm and is available in four lengths 40 mm, 50 mm, 60 mm and 70 mm with reducing bushings to allow the use of different diameter rods proximally and distally to better fit the medullary canal. If the defect size is larger than 70 mm, two attachment shells can be connected by a spacer connector.
All components of the OsteoBridge™ IDSF system are manufactured from Ti-6Al-4V titanium alloy conforming to ASTM F 136-13.
Indications for Use
The device is intended to be used in the management of segmental diaphyseal bone loss of the femur in oncology patients secondary to radical bone loss and/or resection due to tumors. The intramedullary rods can be fixed with interlocking screws without or with bone cement.
Substantial Equivalence:
The OsteoBridge™ IDSF System is technologically equivalent to the predicate devices.
Legally marketed Devices to which substantial Equivalence is claimed
K051965 - OsteoBridge™ IDSF Intramedullary Diaphyseal Segmental Defect Fixation System
K113303 - OsteoBridge™ IDSF Intramedullary Diaphyseal Segmental Defect Fixation System
Non-Clinical Performance Data:
In order to demonstrate that the OsteoBridge™ IDSF has the mechanical properties necessary to perform its intended use, and that the device performs as well as or better than the predicate device. Merete has conducted mechanical and functional testing (according to ASTM F-1264-03). The tests represent the worst case scenario for the strength of the system. All products have successfully passed all tests. The OsteoBridge™ IDSF system has hereby been proven to be mechanically safe.