Who is the manufacturer of LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWS?

Howmedica Leibinger, Inc. filed the 510(k) submission for LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWS (K963741).

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

HRS. It is classified under 21 CFR 888.3030 as a Class 2 device in the Orthopedic panel.

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

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

What are the predicate devices for LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL 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 CRANIOMAXILLOFACIAL 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 CRANIOMAXILLOFACIAL BONE SCREWS

K963741 · Howmedica Leibinger, Inc. · HRS · Feb 6, 1997 · Orthopedic

Device Facts

Record ID	K963741
Device Name	LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWS
Applicant	Howmedica Leibinger, Inc.
Product Code	HRS · Orthopedic
Decision Date	Feb 6, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3030
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 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.

Indications for Use

Indicated for internal fixation of small bones, including craniomaxillofacial skeleton, following trauma or for reconstruction.

Regulatory Classification

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

Related Devices

K963739 — LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS · Howmedica Leibinger, Inc. · Jan 22, 1997
K031028 — THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY · Bioplate, Inc. · Apr 28, 2003
K030806 — BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY · Bioplate, Inc. · Apr 8, 2003
K021618 — OSA RIGID INTERNAL FIXATION SYSTEM · Osteomed Corp. · Aug 8, 2002
K060492 — AESCULAP CRANIOFACIAL PLATE AND SCREW · Aesculap, Inc. · Apr 7, 2006

Submission Summary (Full Text)

{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.