← Product Code [JEY](/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY) · K970911 # LEE PLATE (K970911) _Howmedica Leibinger, Inc. · JEY · Apr 11, 1997 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K970911 ## Device Facts - **Applicant:** Howmedica Leibinger, Inc. - **Product Code:** [JEY](/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY.md) - **Decision Date:** Apr 11, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.4760 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Intended Use The Lee Plate is intended for use in internal fixation of corrective osteotomies to the symphysis region of the mandible (genioplasty procedures). The basic operational principle is to provide fixation/stabilization of an anterior mandibular bone segment that is freed during a corrective osteotomy procedure. ## Device Story Lee Plate is a small bone plate for internal fixation of mandibular symphysis osteotomies (genioplasty). Device provides stabilization of anterior mandibular bone segments post-osteotomy. Plate features screw holes for attachment to bone using 1.7 mm or 2.0 mm diameter screws. Used by surgeons in clinical settings. Benefits include mechanical fixation of bone segments to facilitate healing during corrective procedures. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Commercially pure titanium bone plate. Features screw holes for 1.7 mm and 2.0 mm diameter screws. Mechanical fixation device. No software or electronic components. ## Regulatory Identification A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments. ## Predicate Devices - Profil-O-Plastic Chinplate ([K862534](/device/K862534.md)) - Paulus Titanium Mini Bone Plates and Screws ([K862534](/device/K862534.md)) ## 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} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 11 1997 Ms. Kristyn R. Waski Product Engineer--Special Projects Howmedica Leibinger, Incorporated 14540 Beltwood Parkway East Dallas, Texas 75244 Re: K970911 Trade Name: Lee Plate Regulatory Class: II Product Code: JEY Dated: March 10, 1997 Received: March 12, 1997 Dear Ms. Waski: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {1} Page 2 - Ms. Waski This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597. Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2} 510(k) Number (if known): ___________________________________________________________________________________________ Device Name: Lee Plate Indications for Use: The Lee Plate is intended for use in internal fixation of corrective osteotomies to the symphysis region of the mandible (genioplasty procedures). The basic operational principle is to provide fixation/stabilization of an anterior mandibular bone segment that is freed during a corrective osteotomy procedure. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) SUNSET PUNITI Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K970 411 Prescription Use ☑ OR Over-The-Counter Use ☐ (Optional Format 1-2-96) {3} K970911 # 510(k) Summary APR 11 1997 Device Proprietary Name: Lee Plate Device Common Name: Small Bone Plate Classification Name: Bone Plate 872.4760 Name of Submitter: Howmedica Leibinger Inc. Contact Person: Kristyn Waski Quality Assurance/Regulatory Affairs Engineer Howmedica Leibinger Inc. 14540 Beltwood Pkwy., East Dallas, TX 75244 Telephone: (972) 392-3636 Fax: (972) 392-7258 Date Prepared: March 10, 1997 Summary: This submission describes a bone plate intended for use in internal fixation of corrective osteotomies to the symphysis region of the mandible (genioplasty procedures). It is designed to provide fixation to an advanced anterior mandibular bone segment. Screw holes allow for attachment to the anterior mandible and the osteotomized segment. 1.7 mm and 2.0 mm diameter screws are used to attach the plate to bone. Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Profil-O-Plastic Chinplate [K862534 Paulus Titanium Mini Bone Plates and Screws]. Both plates are intended for use in the fixation of corrective mandibular osteotomies. Both plates are manufactured from commercially pure titanium. Both the Lee Plate and the Profil-O-Plastic Plates are contoured plates with screw holes to allow for attachment to mandibular bone. The operational principle and indications and contraindications are equivalent for both of these devices. --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K970911](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K970911) **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