(87 days)
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.
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
The provided text describes a medical device called the OsteoBridge® IKA Intramedullary Knee Arthrodesis Rod Fixation System and its 510(k) submission for FDA clearance. The document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing rather than clinical performance based on diagnostic accuracy or reader studies.
Therefore, many of the requested criteria related to diagnostic performance (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, ground truth type for test set and training set, training set size) are not applicable or not provided in the given summary. This type of submission relies on engineering and material performance data.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study Type |
|---|---|---|
| Mechanical Strength (Static Torsion Test) | All tests were passed. The device performed as well as or better than the predicate device. | Mechanical Testing (Worst Case Scenario) |
| Mechanical Strength (Four-Point Bending Fatigue Test) | All tests were passed. The device performed as well as or better than the predicate device. | Mechanical Testing (Worst Case Scenario) |
| Mechanical Strength (Three-Point Bending Fatigue Test of IDSF Locking Screws) | All tests were passed. The device performed as well as or better than the predicate device. | Mechanical Testing (Worst Case Scenario) |
| Material Compatibility | All components manufactured from Ti-6Al-4V conforming to ISO 5832-3. | Material Specification |
| Comparable Functionality to Predicate Devices | Same functional characteristics as predicate device (modular internal rod fixation system), same intended use as predicate (K050938). | Comparison to Predicate Devices |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable in the context of diagnostic accuracy/reader studies. The "test set" here refers to the physical devices and materials used for mechanical testing. The specific number of physical units subjected to each mechanical test is not provided in this summary, but it implies a sufficient number for robust engineering evaluation.
- Data Provenance: Not applicable in the context of diagnostic accuracy/reader studies. The mechanical testing was conducted by Merete to assess the physical properties of their device. The location of the testing is not explicitly stated beyond Merete Medical GmbH being in Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a mechanical implant, and the assessment is based on its physical and mechanical properties, not expert interpretation of medical images or symptoms.
4. Adjudication method for the test set
- Not applicable. This relates to expert consensus in diagnostic studies, which is not relevant here. Mechanical tests follow predefined engineering standards and objective measurements.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI-assisted diagnostic device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not a diagnostic algorithm; it is a physical implant.
7. The type of ground truth used
- For the mechanical tests, the "ground truth" is defined by engineering standards and specifications for strength, fatigue resistance, and material properties. The device's performance against these pre-defined mechanical thresholds serves as the ground truth for its acceptability.
8. The sample size for the training set
- Not applicable. This refers to training data for machine learning algorithms, which is not relevant for this device.
9. How the ground truth for the training set was established
- Not applicable. As above, this is not relevant for this device.
{0}------------------------------------------------
2. 510(k) Summary of Safety and Effectiveness Information
| Date Prepared: | June 14, 2010 |
|---|---|
| Date Revised: | October 6, 2010 |
| Submitted by: | Merete Medical GmbHAlt Lankwitz 102,12247 Berlin Germany |
| OCT 7 2010 | |
| Contact Person: | Donna ColemanMerete Medical, Inc.49 Purchase StreetRye, New York 10580Phone: 914 967 1532Fax: 914 967 1542 |
| FDA Registration Number: | 3002949614 |
| Proprietary Name: | OsteoBridge® IKA Intramedullary Knee ArthrodesisRod 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 GmbHWilly-Rüsch-Str. 4-1071394 Kernen-RommelshausenCertificates 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.
Page 5 of 64
{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
Page 3 of 64
§ 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.