TWIST-OFF SCREW

K962233 · Landos, Inc. · HWC · Oct 3, 1996 · Orthopedic

Device Facts

• Record ID: K962233
• Device Name: TWIST-OFF SCREW
• Applicant: Landos, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Oct 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TWIST-OFF™ SCREW is intended to be implanted for fixation of bone fractures or bone reconstructions.

Device Story

The TWIST-OFF™ SCREW is a single-piece, self-tapping, self-compressive titanium bone fixation appliance. It consists of a screw and a support component that separate upon contact with the bone cortex. Available in lengths of 11, 12, 13, and 14 mm. Used by surgeons in clinical settings for fixation of small bone fractures or reconstructions, specifically elective osteotomies of foot metatarsals and phalanges. The device is compatible with power drills. It provides mechanical stabilization of bone segments to facilitate healing.

Clinical Evidence

Bench testing only. Rupture torque testing performed and compared against French Standard N° NF-F-90-414; device found to be in compliance with torsion resistance requirements.

Technological Characteristics

Material: Titanium alloy. Design: Self-tapping, self-compressive, single-piece screw with separable support. Dimensions: 11-14 mm lengths. Operation: Mechanical fixation, compatible with power drill. Standards: Tested for torsion resistance per French Standard N° NF-F-90-414.

Indications for Use

Indicated for fixing and stabilizing elective osteotomies of metatarsals and phalanges of the foot.

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

• M3 Screw system (Osteomed) (K924018, K924138)
• Luhr Screw System (Howmedica) (K950595)
• Cortex Screw (Synthes) (K952272)

Submission Summary (Full Text)

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K96233

L

Landos Inc.

OCT - 3 1996

A SUBSIDIARY OF GROUP LANDANGER CAMUS

# 3. SUMMARY OF SAFETY AND EFFECTIVENESS

## MANUFACTURER IDENTIFICATION:
Medinov - AMP
Z.I. Bapaume
27-31 rue Lucien Langénieux
42335 Roanne Cedex
FRANCE

## SPONSOR IDENTIFICATION
LANDOS INC.
Mr. Jean-Paul Burtin
100 Lindenwood Drive
Malvern, PA 19355

## ESTABLISHMENT REGISTRATION NUMBER:
2530066

## OFFICIAL CONTACT PERSON:
Norman F. Estrin, Ph. D., RAC
President
Estrin Consulting Group, Inc.
9109 Copenhaver Drive
Potomac, MD 20854
Tel.: [phone]
Fax: [phone]

## DATE OF PREPARATION OF THIS SUMMARY:
May 22, 1996

## TRADE NAME:
TWIST-OFF™ SCREW

## COMMON NAME:
Bone Fixation Screw

## CLASSIFICATION NAME AND REFERENCE:
Screw, Fixation, Bone
(21 CFR, Section 888.3040)

## PROPOSED REGULATORY CLASS:
Class II

100 Lindenwood Drive • Malvern, PA 19355
Telephone: [phone] • Fax: [phone]
000013

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000014

DEVICE PRODUCT CODE: 87HWC

PANEL CODE: 87OR

DESCRIPTION OF DEVICE: The TWIST-OFF™ SCREW is a threaded Titanium bone fixation appliance intended to be implanted. It is composed of a self-tapping, self-compressive screw and support as a single piece. These two components separate when the screw head comes in contact with the cortex. Screws come in lengths of 11, 12, 13 and 14 mm; the support does not vary in size.

INTENDED USE: The TWIST-OFF™ SCREW is intended to be implanted for fixation of bone fractures or bone reconstructions.

INDICATIONS FOR USE: The TWIST-OFF™ SCREW is indicated for fixing and stabilizing elective osteotomies of metatarsals and phalanges of the foot.

PREDICATE DEVICE: The TWIST-OFF™ SCREW is substantially equivalent to the M3 Screw system (Osteomed) (K924018, K924138), the Luhr Screw System (Howmedica)(K950595) and the Cortex Screw (Synthes)(K952272).

COMPARISON OF USES/ TECHNOLOGICAL CHARACTERISTICS: Both the TWIST-OFF™ SCREW and its predicates have the same intended use. All are used for fixation of small bones. The M3 and TWIST-OFF™ SCREW are made of the same Titanium alloy. The Cortex is made from a different Ti alloy; the Luhr Screw is made from Cobalt-Chromium. The M3 and the TWIST-OFF™ SCREW are partially threaded and are self-tapping low profile head screws. Both the M3 and the TWIST-OFF™ SCREW can be used with a power drill.

SUMMARY OF STUDIES: Rupture torque of the TWIST-OFF™ SCREW was compared with requirements of the French Standard N° NF-F-90-414 and found to have a resistance to torsion in compliance with the selected Standard.