Who is the manufacturer of LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS?

Howmedica Leibinger, Inc. filed the 510(k) submission for LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS (K963739).

What is the FDA product code for LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS?

HWC. It is classified under 21 CFR 888.3040 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS?

510(k) clearance (submission type: Traditional).

What are the predicate devices for LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS?

Howmedica Luhr® Fixation System (K761228, K882454, K913355, K935448); Wurzburg® Bone Screws (K854886); Steinhauser® Bone Screws (K862482); Howmedica Leibinger Forefoot Reconstruction System (K961485).

Who can help prepare an FDA 510(k) submission like LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS

K963739 · Howmedica Leibinger, Inc. · HWC · Jan 22, 1997 · Orthopedic

Device Facts

Record ID	K963739
Device Name	LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS
Applicant	Howmedica Leibinger, Inc.
Product Code	HWC · Orthopedic
Decision Date	Jan 22, 1997
Decision	SN
Submission Type	Traditional
Regulation	21 CFR 888.3040
Device Class	Class 2
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 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.

Indications for Use

Indicated for internal fixation of small bones in the hand and foot, secondary to trauma or for reconstruction.

Regulatory Classification

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, K882454, K913355, K935448)
Wurzburg® Bone Screws (K854886)
Steinhauser® Bone Screws (K862482)
Howmedica Leibinger Forefoot Reconstruction System (K961485)

Related Devices

K963741 — LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWS · Howmedica Leibinger, Inc. · Feb 6, 1997
K040598 — KLS MARTIN HAND PLATING SYSTEM · KLS-Martin L.P. · May 13, 2004
K961485 — FOREFOOT RECONSTRUCTION SYSTEM · Howmedica Corp. · Jun 1, 1996
K190365 — Baby Gorilla/Gorilla Plating System · Paragon 28, Inc. · Apr 12, 2019
K220723 — Hand Trauma Screw System · Skeletal Dynamics, Inc. · May 12, 2022

Submission Summary (Full Text)

{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.