← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K963739 # LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS (K963739) _Howmedica Leibinger, Inc. · HWC · Jan 22, 1997 · Orthopedic · SN_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K963739 ## Device Facts - **Applicant:** Howmedica Leibinger, Inc. - **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md) - **Decision Date:** Jan 22, 1997 - **Decision:** SN - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use This submission describes a system of small bone screws. It is intended for use in internal fixation of small bones including the hand and foot secondary to trauma or for reconstruction. ## Device Story Small bone screw system for internal fixation of hand and foot bones; used in trauma or reconstruction procedures. Screws range 0.8-3.5 mm diameter, 2-40 mm length. Single-use metallic fixation appliances. Operated by surgeons in clinical/OR settings. Provides mechanical stabilization of bone fragments to facilitate healing. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Metallic bone fixation screws; material Ti6Al4V; diameters 0.8-3.5 mm; lengths 2-40 mm; single-use; mechanical fixation principle. ## Regulatory Identification A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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} K96 3739 510(k) Summary JAN 22 1997 Device Proprietary Name: Leibinger™ - Luhr® Small Orthopedic 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 hand and foot secondary to trauma or for reconstruction. Screws are available in diameters ranging from 0.8 to 3.5 mm and lengths ranging from 2 mm to 40 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®, Profyle 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/HWC/K963739](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K963739) **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. 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