(331 days)
No
The device description and performance studies focus on mechanical properties and modular design, with no mention of AI/ML or related concepts.
No
The device is an intramedullary rod system intended for orthopedic fixation to bridge bone loss, acting as a mechanical support rather than directly treating or curing a disease state.
No
The device is described as an intramedullary rod system for fixing bone defects, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical intramedullary rod system made of titanium alloy, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in the management of segmental diaphyseal bone loss and to bridge the bone defect. This is a surgical implant used to physically support and stabilize bone, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a system of modular intramedullary rods made of Titanium Alloy designed to be attached together to form a complete intramedullary rod and bridge the bone defect. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, calibrators, controls, or any other components typically associated with in vitro diagnostic devices.
- Performance Studies: The performance studies described are mechanical testing (bend, torsion, fatigue), which are relevant to the structural integrity of a surgical implant, not the analytical or clinical performance of an IVD.
In summary, the OsteoBridge® IDSF is a surgical implant designed to fix bone defects, not a device used for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The device is intended to be used in the management of segmental diaphyseal bone loss of either humerus or tibia or 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
OsteoBridge® IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System is a series of modular intramedulary rods 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 semiciteular hollow attachment shells that are clamped together with multiple screws to create a complete intramedullary rod and bridge the bonaliped with middle section of either humerus, tibia or femur. Reducing bushings allow the use of different diameter nails proximally and distally to provide optimal fit of the intract and with the medillary canal of the proximally and and distal segments of the bone to be fixed. All components of the OsteoBridge® Humeral IDSF -Intramedullary Segment Fixation Rod System are manufactured from Ti-6Al-4V Titanium Alloy conforming to ASTM F-136. The device is divided into three categories/product size ranges that are suitable for each boney application; humerus, tibia or femur (see tables below).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humerus, tibia, 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)
Mechanical Testing: In order to demonstrate that the OsteoBridge® IDSF has the mechanical properties necessary to perform its intended use Merete has conducted mechanical and functional testing according to ASTM F-1264-03. This includes: - Static Four-Point Bend Test . - Static Torsion Test . - Four-Point Bending Fatigue Test . - Three-Point Bending Fatigue Test of the IDSF Locking Screws The "worst case" of each category (humeral, tibial, and femoral) was tested.
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.
K934643, K882443, K871539, K933518, K914453, K893377, K980609, K954559, K853250
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.
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
K051965 510 K Summary
| Submitted by: | Merete Medical GmbH
Alt Lankwitz 102,
12247 Berlin, Germany |
|----------------------------|--------------------------------------------------------------------------------------|
| US Contact Person: | Carl Knobloch
5349 Red Leaf Court
Oviedo, FL 32765 |
| Device Name: | OsteoBridge® IDSF - Intramedullary Diaphyseal Segmenta
Defect Fixation Rod System |
| Device Classification: | 21 CFR 888.3020 Intramedullary fixation rod |
| Product Code: | HSB |
| Proposed Regulatory Class: | Class II |
| | JUN 16 2006 |
Predicate Device:
- ACE Aim Humeral Nail (K934643)
- Ace Aim Tibial Nail (K934643) -
- Zindrick IM Rod (K882443); Later named ACE AIM Femoral Nail (K871539) -
- Synthes Unreamed Humeral Nail (UHM) (K933518) -
- Synthes Unreamed Tibial Nail (UTN) (K914453) ﺖ
- Russell-Taylor Femoral Nail (K893377) -
- Metagen Segmental Defect Replacement System (K980609) -
- Howmedica Modular Proximal Humerus Replacement System (K954559) -
- Zimmer Femorotibial Medullary Nail (K853250) -
Clinically Related Devices:
- Modular Oncology System Technology (K960626) -
- --SOS Proximal Femur (K933281)
- Modular Intercalary Humeral Spacer (Mayo Clinic) (Damron et al, 1996) -
Device Description:
OsteoBridge® İDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System is a series of modular intramedulary rods 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 semiciteular hollow attachment shells that are clamped together with multiple screws to create a complete intramedullary rod and bridge the bonaliped with middle section of either humerus, tibia or femur. Reducing bushings allow the use of different diameter nails proximally and distally to provide optimal fit of the intract and with the medillary canal of the proximally and and distal segments of the bone to be fixed. All components of the OsteoBridge® Humeral IDSF -Intramedullary Segment Fixation Rod System are manufactured from Ti-6Al-4V Titanium Alloy conforming to ASTM F-136. The device is divided into three categories/product size ranges that are suitable for each boney application; humerus, tibia or femur (see tables below).
| Humerus | |||
|---|---|---|---|
| Attachment Shell | Nail | ||
| Dia [mm] | Length [mm] | Dia [mm] | Length [mm] |
1
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|--------------------------------------|----------------|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | |
| An | 50 60 70
10 | | |
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| 1777 |
9 | | Separating of Children & Children and | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
The Nails diameter 7 mm and 8 mm accept interlocking bone screws in diameter 3,8 mm. The Nails diameter 9 mm and 10 mm accept interlocking bone screws in diameter 5,0 mm.
| Nail | |||
|---|---|---|---|
| Tibia | |||
| Attachment Shell | |||
| Dia [mm] | Length [mm] | Dia [mm] | Length [mm] |
| 25 | 40, 50, 60, 70 | 9 | 60, 70, 90 |
| 10 | 60, 70, 90, 110, 130 | ||
| 12 | 70, 90, 110, 130, 150 | ||
| 14 | 90, 110, 130, 150, 200 |
The Nails diameter 9 mm and 14 mm accept interlocking bone screws in diameter 5,0 mm.
| Femur | |||
|---|---|---|---|
| Attachment Shell | Nail | ||
| Dia [mm] | Length [mm] | Dia [mm] | Length [mm] |
| 40, 50, 60, 70 | 10 | 60, 70, 90, 110, 130 | |
| 30 | 12 | 70, 90, 110, 130, 150 | |
| 14 | 90, 110, 130, 150, 200 | ||
| 16 | 110, 130, 150, 200 |
The Nails diameter 10 mm and 16 mm accept interlocking bone screws in diameter 5,0 mm.
Intended use:
The device is intended to be used in the management of segmental diaphyseal bone loss of either humerus or tibia or femur in oncology patients secondary to radical bone Joss and/or ressorting due to tumors. The intramedullary rods can be fixed with interlocking screws without or overth bone cement.
Mechanical Testing:
In order to demonstrate that the OsteoBridge® IDSF has the mechanical properties necessary to perform its intended use Merete has conducted mechanical and functional testing according to ASTM F-1264-03. This includes:
- Static Four-Point Bend Test .
- Static Torsion Test .
- Four-Point Bending Fatigue Test .
- Three-Point Bending Fatigue Test of the IDSF Locking Screws
The "worst case" of each category (humeral, tibial, and femoral) was tested.
4. Standards
- OsteoBridge® IDSF is produced from titanium alloy Ti-6Al-4V according to ASTM F-136 and . ISO 5832/3.
- Mechanical tests have been carried out according to ASTM F-1264-03. ャ
- The sterile components are sterilized according to ANSI/AAMI ST32-1991; Method I t
- We recommend sterilizing the non sterile components according to the sterility validation . Method ANSI ST46-1993-Prevacuum Steam Sterilization of Medical Devices.
2
Image /page/2/Picture/1 description: The image shows a black and white logo. The logo consists of a circular border with text around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other. The faces are represented by simple, curved lines, and they appear to be facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 6 2006
Merete Medical GmbH % Turnkey Integration USA Mr. Carl Knobloch 5349 Red Leaf Court Ovieda, Florida 32765
Re: K051965
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: June 1, 2006 Received: June 2, 2006
Dear Mr. Knobloch:
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
3
Page 2 – Mr. Carl Knobloch
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 for h 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. 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/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buehrle
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices . Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
2. Indications for Use of OsteoBridge® IDSF
Indications for Use
510(k) Number (if known): K051965
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 either humerus or tibia or 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)
Chürbare Ductin
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| Merete Medical GmbH | February 2006 | Page 5 of 35 |
|---|---|---|
| 510(k) Number | K051965 |