(30 days)
Not Found
No
The summary describes a mechanical intramedullary rod system for knee arthrodesis and contains no mention of AI, ML, or related concepts.
Yes
The device is described as an "Intramedullary Knee Arthrodesis Rod Fixation System" intended for conditions like "Irretrievably failed total knee arthroplasty," "Limb salvage," and "Oncology surgery," which are all therapeutic interventions aimed at treating a medical condition or pathology.
No
Explanation: The device is an intramedullary rod fixation system intended for surgical arthrodesis (fusion) of the knee, not for diagnosing medical conditions.
No
The device description clearly states "Intramedullary Knee Arthrodesis Rod Fixation System," indicating a physical hardware device (rods and screws) used for surgical fixation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Intramedullary knee arthrodesis," which is a surgical procedure performed directly on the patient's body to fuse the knee joint.
- Device Description: The device is described as an "Intramedullary Knee Arthrodesis Rod Fixation System," which is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health.
IVDs are used to diagnose, monitor, or screen for diseases or conditions by analyzing samples taken from the body. This device is a surgical implant used for structural support and fusion within the body.
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
HSB
Device Description
Not Found
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
Prescription Use
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.
Public Health Service .
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 Alt-Lankwitz 102 12247 Berlin DE
MAY - 2 2012
Re: K120978
Trade/Device Name: OsteoBridge® IKA Intramedullary Knee Arthrodesis Rod Fixation System
Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: May 26, 2011 Received: May 27, 2011
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.
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Mr. Emmanuel Anapliotis
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.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 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 yours.
Sincerely, yours,
Erinl Keith
ン~Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Special 510{k} Submission - Modification to K101939 - OsteoBridge® IKA
Attachment 2
Indications for Use Statement
510(k) Number (if known): . . . . . . . . . . .
OsteoBridge® IKA Intramedullary Knee Arthrodesis· Rod Fixation Device Name: 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)
Asrt
(Division Sign-Off) Division of Surgical. Orthopedic, and Restorall ve Beach GmbH
March 2012
510(k) Number