OSTEOBRIDGE IDSF INTRAMEDULLARY DIAPHYSEAL SEGMENTAL DEFECT FIXATION ROD SYSTEM

{0}------------------------------------------------ # K051965 510 K Summary | Submitted by: | Merete Medical GmbH<br>Alt Lankwitz 102,<br>12247 Berlin, Germany | |----------------------------|--------------------------------------------------------------------------------------| | US Contact Person: | Carl Knobloch<br>5349 Red Leaf Court<br>Oviedo, FL 32765 | | Device Name: | OsteoBridge® IDSF - Intramedullary Diaphyseal Segmenta<br>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}------------------------------------------------ | A Court &<br>And Analy Andrew | | Access of any home the condition of the designed to the designed<br> | | |--------------------------------------|----------------|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | | An | 50 60 70<br>10 | | | | | | | ware and suggest it in i in i<br>OU | | -------------------<br>1777<br><br>9 | | Separating of Children & Children and | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 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<br>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<br>(Part 21 CFR 801 Subpart D) | <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M14.3536 2.35355C14.5488 2.15829 14.5488 1.84171 14.3536 1.64645C14.1583 1.45118 13.8417 1.45118 13.6464 1.64645L7.64645 7.64645L2.35355 2.35355C2.15829 2.15829 1.84171 2.15829 1.64645 2.35355C1.45118 2.54882 1.45118 2.8654 1.64645 3.06066L7.64645 9.06066L13.6464 3.06066C13.8417 2.8654 14.1583 2.8654 14.3536 3.06066C14.5488 3.25593 14.5488 2.93934 14.3536 2.35355Z" fill="black"></path> </svg> | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| 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 | |