OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR
Device Facts
| Record ID | K120978 |
|---|---|
| Device Name | OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR |
| Applicant | Merete Medical GmbH |
| Product Code | HSB · Orthopedic |
| Decision Date | May 2, 2012 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 888.3020 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
Intramedullary knee arthrodesis
Device Story
OsteoBridge® IKA is an intramedullary knee arthrodesis rod fixation system used for stabilizing the knee joint. The device consists of an intramedullary rod that provides structural support across the knee joint, which can be secured using interlocking screws, with or without the use of bone cement. It is intended for use by orthopedic surgeons in clinical or surgical settings to achieve arthrodesis in patients with compromised joint integrity. By providing rigid internal fixation, the device facilitates bone fusion, aiding in limb salvage and functional restoration in complex orthopedic cases.
Clinical Evidence
Bench testing only.
Technological Characteristics
Intramedullary fixation rod system; metallic construction; utilizes interlocking screws for fixation; compatible with bone cement; designed for intramedullary placement.
Indications for Use
Indicated for patients with irretrievably failed total knee arthroplasty, requiring limb salvage, undergoing oncology surgery, or other conditions where limited soft or bony tissue support necessitates arthrodesis as the treatment of choice.
Regulatory Classification
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.
Predicate Devices
- OsteoBridge® IKA Intramedullary Knee Arthrodesis Rod Fixation System (K101939)
Related Devices
- K101939 — OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM · Merete Medical GmbH · Oct 7, 2010
- K061783 — KNEE FUSION NAIL · Smith & Nephew, Inc. · Aug 10, 2006
- K050938 — KNEE FUSION NAIL · Smith & Nephew, Inc. · May 4, 2005
- K113303 — OSLEOBRIDGE IDSF SPACER CONECTOR · Merete Medical GmbH · Dec 9, 2011
- K042409 — MODULAR ARTHRODESIS NAIL · Biomet, Inc. · Dec 2, 2004
Submission Summary (Full Text)
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# 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
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### 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
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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:
- 1. Irretrievably failed total knee arthroplasty
- 2. Limb salvage
- 3. Oncology surgery
- 4. 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
