← Product Code [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS) · K963741 # LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWS (K963741) _Howmedica Leibinger, Inc. · HRS · Feb 6, 1997 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K963741 ## Device Facts - **Applicant:** Howmedica Leibinger, Inc. - **Product Code:** [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS.md) - **Decision Date:** Feb 6, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use This submission describes a system of small bone screws. It is intended for use in internal fixation of small bones including the craniomaxillofacial skeleton secondary to trauma or for reconstruction. ## Device Story Small bone screw system; diameters 0.8-2.4 mm; lengths 2-28 mm. Used for internal fixation of craniomaxillofacial skeleton; trauma or reconstruction applications. Single-use only. Operational principle involves mechanical bone fixation via screw insertion. Used by surgeons in clinical/OR settings. Output is physical stabilization of bone fragments; aids healing/reconstruction. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Metallic bone fixation screws; diameters 0.8-2.4 mm; lengths 2-28 mm. Material: Ti6Al4V (referenced from Forefoot Reconstruction System). Mechanical fixation principle. Single-use. ## 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 - Howmedica Luhr® Fixation System ([K761228](/device/K761228.md), [K882454](/device/K882454.md), [K913355](/device/K913355.md), [K935448](/device/K935448.md)) - Wurzburg® Bone Screws ([K854886](/device/K854886.md)) - Steinhauser® Bone Screws ([K862482](/device/K862482.md)) - Howmedica Leibinger Forefoot Reconstruction System ([K961485](/device/K961485.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} FEB - 6 1997 K963741 # 510(k) Summary | Device Proprietary Name: | Leibinger® - Luhr® Small Craniomaxillofacial Bone Screw System | | --- | --- | | Device Common Name: | Small Bone Screws | | Classification Name: | Single/Multiple Component Metallic Bone Fixation Appliances and Accessories 888.3030 | | Name of Submitter: | Howmedica Leibinger Inc. | | Contact Person (s): | Andrew B. Rogers Director, Product Development and Special Projects Howmedica Leibinger Inc. 14540 Beltwood Pkwy. East Dallas, TX 75244 Telephone: (214) 392-3636 x233 Fax: (214) 392-7258 | | | Kristyn R. Waski Product Engineer, Special Projects Howmedica Leibinger Inc. 14540 Beltwood Pkwy. East Dallas, TX 75244 Telephone: (214) 392-3636 x266 Fax: (214) 392-7258 | | Date Prepared: | September 12, 1996 | ## Summary: This submission describes a system of small bone screws. It is intended for use in internal fixation of small bones including the craniomaxillofacial skeleton secondary to trauma or for reconstruction. Screws are available in diameters ranging from 0.8 to 2.4 mm and lengths ranging from 2 mm to 28 mm. These devices are for single use only. Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Howmedica Luhr® Fixation System (K761228,K882454, K913355, K935448); the Wurzburg® Bone Screws (K854886); the Steinhauser® Bone Screws (K862482) and the Howmedica Leibinger Forefoot Reconstruction System (K961485). The Luhr®, Wurzburg® and Steinhauser®, and Forefoot bone screws are intended for use as small bone screws in internal fixation procedures. The Forefoot screws are manufactured from Ti6Al4V. The basic operational principle is similar for each of these devices. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K963741](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K963741) **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