SCARF THREAD-HEAD SCREW

K962236 · Landos, Inc. · HWC · Sep 20, 1996 · Orthopedic

Device Facts

• Record ID: K962236
• Device Name: SCARF THREAD-HEAD SCREW
• Applicant: Landos, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Sep 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SCARF THREAD-HEAD™ SCREW is intended to be implanted for fixation of bone fractures or bone reconstructions.

Device Story

Cannulated bone fixation screw; titanium alloy construction; lengths 10-32 mm. Used by orthopedic surgeons for internal fixation of foot osteotomies. Provides mechanical stability to bone fragments during healing. Implanted via surgical procedure; cannulated design allows placement over guidewire. Benefits patient by maintaining bone alignment post-osteotomy.

Clinical Evidence

Bench testing only. Rupture torque testing performed per French Standard NF-F-90-414; device demonstrated compliance with torsion resistance requirements.

Technological Characteristics

Cannulated bone screw; titanium alloy; lengths 10-32 mm (2 mm increments); hexagonal socket head; threaded design.

Indications for Use

Indicated for fixing elective osteotomies of mid-foot bones, 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

• Medinov-AMP Scarf Screw (K931155)
• Herbert-Whipple Bone Screw (Zimmer) (K792022)
• M3 Screw System (Osteomed) (K924018, 924138)

Submission Summary (Full Text)

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Landos Inc. K962236
A SUBSIDIARY OF GROUP LANDANGER CAMUS
SEP 20 1996

# 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:
SCARF THREAD-HEAD™ SCREW

## COMMON NAME:
Bone Fixation Screw

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

## PROPOSED REGULATORY CLASS:
87HWC

## DEVICE PRODUCT CODE:
87HWC

## PANEL CODE:
87OR

100 Lindenwood Drive • Malvern, PA 19355
Telephone: [phone] • Fax: [phone]
00001C

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DESCRIPTION OF DEVICE:

The SCARF THREAD-HEAD™ SCREW is a cannulated thread-head screw made of a Titanium alloy. Screws come in lengths of 10-32 mm in 2 mm increments.

INTENDED USE:

The SCARF THREAD-HEAD™ SCREW is intended to be implanted for fixation of bone fractures or bone reconstructions.

INDICATIONS FOR USE:

The SCARF THREAD-HEAD™ SCREW is indicated for fixing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.

PREDICATE DEVICE:

The SCARF THREAD-HEAD™ SCREW is substantially equivalent to the Medinov-AMP Scarf Screw (K931155), the Herbert-Whipple Bone Screw (Zimmer) (K792022) and the M3 Screw System (Osteomed) (K924018, 924138).

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

Both the SCARF THREAD-HEAD™ SCREW, the Scarf Screw and the Herbert-Whipple Bone Screw have the same intended use and all are indicated for fixing small fractures or osteotomies. All are made from Titanium alloys. The SCARF THREAD-HEAD™ SCREW and Scarf Screws are threaded on nearly all their length with the same thread pitch. Both have a thread head and a hexagonal socket. The Scarf screw is not cannulated; the Herbert-Whipple screw is cannulated and is topped with a hexagonal socket.

SUMMARY OF STUDIES:

Rupture torque of the SCARF THREAD-HEAD™ 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.