← Product Code [KTT](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT) · K023941 # SYNTHES TOMOFIX OSTEOTOMY SYSTEM (K023941) _Synthes (Usa) · KTT · Jan 23, 2003 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT/K023941 ## Device Facts - **Applicant:** Synthes (Usa) - **Product Code:** [KTT](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT.md) - **Decision Date:** Jan 23, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use Synthes TomoFix™ Osteotomy System is intended for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia and lateral distal femur, treatment of bone and joint deformities, and malalignment caused by injury or disease such as osteoarthritis. ## Device Story TomoFix™ Osteotomy System comprises five titanium plates designed for orthopedic surgical fixation; includes lateral distal femur plates (left/right), lateral proximal tibia plates (left/right), and medial proximal tibia plate. Plates feature locking and combination holes for bone stabilization. Used by orthopedic surgeons in clinical/OR settings to maintain alignment during bone healing following osteotomy procedures. Benefits include structural support for corrective bone realignment in patients with deformities or osteoarthritis. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Materials: CP Titanium and Ti-6Al-7Nb. Design: Five titanium plates with locking and combination holes. Form factor: Anatomically specific plates for lateral distal femur and proximal tibia (medial/lateral). Energy source: None (mechanical fixation). ## 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 - Anatomical Locking Plate System - Synthes Locking Condylar Plates - Synthes Large Fragment LCP System - Synthes LCP Proximal Tibia Plate ## 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}------------------------------------------------ K023941 page 1 of 1 ## 3.0 Summary of Safety and Effectiveness Information JAN 23 2003 | SPONSOR: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700 | |---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | COMPANY CONTACT: | Lisa M. Boyle
(610) 647-9700 | | NAME OF DEVICE: | Synthes TomoFix™ Osteotomy System | | CLASSIFICATION: | Class II, § 888.3030 - Single / multiple component metallic bone fixation
appliance and accessories, and
Class II, § 888.3040 - Smooth or threaded metallic bone fixation fastener. | | PREDICATE DEVICE: | The Synthes TomoFix™ Osteotomy System is similar to the following
Synthes devices which have been cleared via the premarket notification
process: Anatomical Locking Plate System, Synthes Locking Condylar
Plates , Synthes Large Fragment LCP System, and Synthes LCP Proximal
Tibia Plate. | | DEVICE DESCRIPTION: | The TomoFix™ Osteotomy System consists of five different titanium plates
with locking and combination holes. There are two plates (left and right)
for the lateral distal femur, 2 plates (left and right) for the lateral proximal
tibia, and 1 plate for the medial proximal tibia. | | INTENDED USE: | Synthes TomoFix™ Osteotomy System is intended for open and closed
wedge osteotomies of the medial proximal tibia, lateral proximal tibia and
lateral distal femur, treatment of bone and joint deformities, and
malalignment caused by injury or disease such as osteoarthritis. | | MATERIAL: | CP Titanium, Titanium-6Aluminum-7Niobium (Ti-6Al-7Nb) | Confidential {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle. Public Health Service JAN 2 3 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Synthes (USA) Lisa M. Boyle Regulatory Associate 1690 Russell Road P. O. Box 1766 Paoli. Pennsylvania 19301 Re: K023941 Trade/Device Name: Synthes TomoFix™ Osteotomy System Regulation Number: 888.3030; 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories; smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: KTT Dated: November 25, 2002 Received: November 26, 2002 Dear Ms. Boyle: 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 controis 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 {2}------------------------------------------------ Page 2 - Ms. Lisa M. Boyle (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely vours. O Mark A. Mellersen Celia M. Witten, Ph.D., M.D. 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 Statement 510(k) Number (if known): Synthes (USA) TomoFix™ Osteotomy System Device Name: Page 1 Indications/Contraindications: Synthes TomoFix™ Osteotomy System is intended for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia and lateral distal femur, treatment of bone and joint deformities, and malalignment caused by injury or disease such as osteoarthritis. (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) OR Over-The-Counter Use Mark A. Millbern ivision Sign-Off) Division of General, Restorative and Neurolonial 510(k) Number K023941 Confidential --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT/K023941](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT/K023941) **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