(87 days)
Not Found
No
The summary describes a purely mechanical intramedullary rod system for knee arthrodesis. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes.
The device is intended to treat a pathological condition (failed total knee arthroplasty, limb salvage, oncology surgery) by providing fixation and promoting arthrodesis, which is a therapeutic intervention.
No
The device is described as an intramedullary rod fixation system used for surgical procedures like knee arthrodesis, not for diagnosing conditions. It is a treatment device, not a diagnostic one.
No
The device description explicitly lists physical components made of Ti-6Al-4V, such as intramedullary rod segments, attachment shells, and interlocking screws. This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this device is an "Intramedullary Knee Arthrodesis Rod Fixation System." Its intended use is for surgical procedures to fuse the knee joint (arthrodesis) in specific clinical situations. This involves implanting a physical device into the bone.
- Lack of Biological Sample Analysis: There is no mention of this device analyzing any biological samples from the patient. Its function is purely mechanical and structural, providing fixation and support within the bone.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Intramedullary knee arthrodesis
Indications include:
- Irretrievably failed total knee arthroplasty
- Limb salvage
- Oncology surgery
- Any other condition where there is little soft tissue or bony tissue available for support and arthrodesis is the treatment of choice
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® Intramedullary Knee Arthrodesis Rod Fixation System (IKA) 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 a semicircular hollow angled attachment shell that is clamped together with multiple screws to create a firm fixation of the bone. We strongly recommend covering the attachment shell with bone graft to enhance callus formation.
all components are manufactured from Ti-6Al-4V conforming to ISO 5832-3. The intramedullary rods can be fixed with interlocking screws without or with bone cement.
The device consists of:
Nails with collar: Dia.: 10, 12, 14 and 16 mm in Lengths: 110, 130 and 150 mm Nails without collar: Dia.: 14, 16 and 18 mm in Lengths: 130, 150 and 200 mm Attachment Shells: 10° Angled: 50 mm length
Interlocking Screws: Dia. 5 mm in lengths: from 20 mm to 56 mm in two millimeter intervals
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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® IKA 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. This includes:
- Static Torsion Test.
- Four-Point Bending Fatigue Test
- Three-Point Bending Fatigue Test of the IDSF Locking Screws (used also for IKA System)
The tests represent the worst case scenario for the strength of the system. All tests were passed.
The "worst case" 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.
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
2. 510(k) Summary of Safety and Effectiveness Information
| Date Prepared: | June 14, 2010 |
|---|---|
| Date Revised: | October 6, 2010 |
| Submitted by: | Merete Medical GmbH |
| Alt Lankwitz 102, | |
| 12247 Berlin Germany | |
| OCT 7 2010 | |
| Contact Person: | Donna Coleman |
| Merete Medical, Inc. | |
| 49 Purchase Street | |
| Rye, New York 10580 | |
| Phone: 914 967 1532 | |
| Fax: 914 967 1542 | |
| FDA Registration Number: | 3002949614 |
| Proprietary Name: | OsteoBridge® IKA Intramedullary Knee Arthrodesis |
| Rod Fixation System | |
| Classification Name: | 21 CFR 888.3020 - Intramedullary fixation rod |
| Product Code: | HSB – Rod, Fixation, Intramedullary and Accessories |
| Proposed Regulatory Class: | Class II |
| Sterilizer (Gamma Radiation): | BBF Sterilisationsservice GmbH |
| Willy-Rüsch-Str. 4-10 | |
| 71394 Kernen-Rommelshausen | |
| Certificates are enclosed in Annex III |
Predicate Device:
| OsteoBridge® IDSF Fixation Rod System (K051965) |
|---|
| Femorotibial Medullary Nail Zimmer Inc. (K853250) |
| Knee Fusion Nail, Smith & Nephew, Inc. (K050938) |
Device Description:
OsteoBridge® Intramedullary Knee Arthrodesis Rod Fixation System (IKA) 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 a semicircular hollow angled attachment shell that is clamped together with multiple screws to create a firm fixation of the bone. We strongly recommend covering the attachment shell with bone graft to enhance callus formation.
all components are manufactured from Ti-6Al-4V conforming to ISO 5832-3. The intramedullary rods can be fixed with interlocking screws without or with bone cement.
1
The device consists of:
Nails with collar: Dia.: 10, 12, 14 and 16 mm in Lengths: 110, 130 and 150 mm Nails without collar: Dia.: 14, 16 and 18 mm in Lengths: 130, 150 and 200 mm Attachment Shells: 10° Angled: 50 mm length
Interlocking Screws: Dia. 5 mm in lengths: from 20 mm to 56 mm in two millimeter intervals
Intended use:
Intramedullary knee arthrodesis
Indications include:
-
- Irretrievably failed total knee arthroplasty
-
- Limb salvage
-
- Oncology surgery
-
- Any other condition where there is little soft tissue or bony tissue available for support and arthrodesis is the treatment of choice
The intramedullary rods can be fixed with interlocking screws without or with bone cement.
Summary of Technologies:
Similarities
The OsteoBridge® IKA has the same functional characteristics (modular internal rod fixation system) as the predicate device (K051965 / K853250 / K050938) and is made of the same titanium alloy material. The OsteoBridge® IKA has the same intended use as the predicate device (K050938).
Differences
In comparison to the above mentioned predicate device (K051965), the OsteoBridge® IKA System is designed for fusion of the knee joint. Both devices are anchored in the diaphysis of the bone. The performance is therefore comparable.
In comparison to the predicate device (K050938) the OsteoBridge® IKA is a modular system with two nails. In comparison to the predicate device (K853250) the two nails of the OsteoBridge® IKA must be joined using the attachment shell.
The OsteoBridge® IKA provides an angled attachment shell to allow the adjustment of extension/flexion and valgus/varus positioning. The nails are modified to meet the needs of the damage following failed total knee arthroplasty.
Mechanical Testing:
In order to demonstrate that the OsteoBridge® IKA 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. This includes:
- Static Torsion Test .
- Four-Point Bending Fatigue Test
- Three-Point Bending Fatigue Test of the IDSF Locking Screws (used also for IKA System)
The tests represent the worst case scenario for the strength of the system. All tests were passed.
The "worst case" was tested.
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2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three horizontal lines that curve and converge, resembling a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Merete Medical GmbH % Mr. Emmanuel Anapliotis President & CEO Alt Lankwitz 102 12247 Berlin, Germany
OLT - 7 2010
Re: K101939
Trade/Device Name: OsteoBridge IKA Intramedullary Knee Arthrodesis Rod Fixation System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: July 7, 2010 Received: July 12, 2010
Dear Mr. Anapliotis:
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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 - Mr. Emmanuel Anapliotis
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.h1m 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
1. Indications for Use of OsteoBridge® IKA
Indications for Use
510(k) Number (if known): K101939
Device Name: OsteoBridge® IKA Intramedullary Knee Arthrodesis Rod Fixation System
Intended Use:
Intramedullary knee arthrodesis
Indications include:
-
- Irretrievably failed total knee arthroplasty
-
- Limb salvage
-
- Oncology surgery
-
- Any other condition where there is little soft tissue or bony tissue available for support and arthrodesis is the treatment of choice
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) | |
|---|---|
| -- | -------------------------------------------------------- |
(Division Sign-Off) (Division Sign-Sical, Orthopedic, Division or and Restorative Devices
510(k) Number
Page 1 of 1
Merete Medical GmbH
Submission Date: June 2010 Revision Date: October 2010
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