← Product Code [KTT](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT) · K082650 # SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL (K082650) _Synthes (Usa) · KTT · Nov 18, 2008 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT/K082650 ## Device Facts - **Applicant:** Synthes (Usa) - **Product Code:** [KTT](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT.md) - **Decision Date:** Nov 18, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: -Stabilization of soft tissues and fractures - Polytrauma/multiple orthopedic trauma - Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures - Arthrodeses and osteotomies with soft tissue problems; failures of total ioints - Neutralization of fractures stabilized with limited internal fixation - Non-unions/septic non-unions - Intra-operative reductions/stabilization tool to assist with indirect reduction - Unilateral rectilinear bone segment transport or leg lengthening ## Device Story Synthes Large External Fixation, MR Conditional, comprises metallic clamps, rods, Schanz screws, and Steinmann pins; also offered as sterile kits including manual surgical instruments. Device provides external skeletal stabilization for long bone and pelvic fractures; used in clinical settings by orthopedic surgeons. System functions as mechanical support for bone segments; allows for fracture reduction, stabilization, and bone transport. MR Conditional status indicates compatibility with magnetic resonance imaging environments under specific conditions. Healthcare providers utilize the system to maintain fracture alignment and stability during healing or surgical procedures; benefits include improved patient outcomes in complex trauma and orthopedic reconstruction cases. ## Clinical Evidence Bench testing only. ## Technological Characteristics Metallic bone fixation components (clamps, rods, Schanz screws, Steinmann pins). MR Conditional. Manual surgical instruments included in kits. No software or electronic components. ## Regulatory Identification Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system. ## Predicate Devices - Synthes External Fixation Devices ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A horizontal line is located underneath the word "SYNTHES". The "®" symbol is located to the right of the word. #### 3.0 510(k) Summary KOS 2650 Page _________________________________________________________________________________________________________________________________________________________________________ Sponsor: Synthes (USA) 1301 Goshen Parkway West Chester. PA 19380 (610) 719-5000 Jill R. Sherman Contact: Synthes (USA) 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6538 Fax: 484-356-9682 Synthes Large External Fixation, MR Conditional Device Name: Classification: 21 CFR Part 888.3030; Single/multiple component metallic bone fixation appliances and accessories. Predicate Devices: Synthes External Fixation Devices Device Description: The Synthes Large External Fixation, MR Conditional consists of previously cleared clamps, rods, Schanz screws and Steinmann pins. Synthes will also offer Sterile Packaged Large External Fixation Kits, MR Conditional. These kits contain previously cleared external fixation devices and manual surgical instruments. Intended Use: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: - -Stabilization of soft tissues and fractures - Polytrauma/multiple orthopedic trauma - - Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures - -Arthrodeses and osteotomies with soft tissue problems; failures of total ioints - Neutralization of fractures stabilized with limited internal fixation - Non-unions/septic non-unions - Intra-operative reductions/stabilization tool to assist with indirect reduction - · Unilateral rectilinear bone segment transport or leg lengthening Information presented supports substantial equivalence. Substantial Equivalence {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # NOV 1 8 2008 Synthes (USA) % Ms. Jill R. Sherman 1301 Goshen Parkway West Chester, PA 19380 Re: K082650 Trade/Device Name: Synthes Large External Fixation, MR Conditional Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories. Regulatory Class: II Product Code: KTT Dated: September 11, 2008 Received: September 12, 2008 Dear Ms. Sherman: 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 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 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. {2}------------------------------------------------ Page 2 - Ms. Jill R. Sherman 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark H. Millman Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ 2.0 Indications for Use 510(k) Number (if known): K082650 Device Name: ### Synthes Large External Fixation, MR Conditional Indications for Use: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: - Stabilization of soft tissues and fractures - - -Polytrauma/multiple orthopedic trauma - Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable ー pelvic fractures - Arthrodeses and osteotomies with soft tissue problems; failures of total joints - Neutralization of fractures stabilized with limited internal fixation - Non-unions/septic non-unions - Intra-operative reductions/stabilization tool to assist with indirect reduction - Unilateral rectilinear bone segment transport or leg lengthening # (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ## Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) AND/OR Da Over-The-Counter Use (21 CFR 807 Subpart C) (Division Sign-Off) Page Division of General, Restorative, and Neurological Devices **510(k) Number** K082650 of --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT/K082650](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT/K082650) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com