34MM SCARF THREAD-HEAD(TM) SCREW

K971068 · Landos, Inc. · HWC · Jul 9, 1997 · Orthopedic

Device Facts

• Record ID: K971068
• Device Name: 34MM SCARF THREAD-HEAD(TM) SCREW
• Applicant: Landos, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Jul 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fixation of fracture, fusion of a joint or bone reconstruction (osteotomy) of the mid-foot, metatarsals and phalanges of the foot.

Device Story

34mm SCARF Thread-Head Screw is a threaded bone fixation device; 3.0mm diameter; 34mm length; titanium alloy construction; cannulated design with threaded head. Device serves as an extension to existing SCARF Thread-Head Screw product line. Intended for surgical implantation by clinicians for orthopedic procedures involving mid-foot, metatarsal, and phalangeal bones. Provides mechanical stabilization for fractures, fusions, or osteotomies.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Material: Titanium alloy. Design: Cannulated, threaded-head bone screw. Dimensions: 3.0mm diameter, 34mm length. Energy source: None (mechanical). Sterilization: Not specified.

Indications for Use

Indicated for patients requiring fixation of fractures, joint fusion, or bone reconstruction (osteotomy) specifically within the mid-foot, 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

• Landos SCARF Thread-Head Screw
• Zimmer Herbert-Whipple Bone Screw
• Osteomed M3 Screw

Submission Summary (Full Text)

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06/26/97 THU 15:08 FAX [phone]
DePuy Clinical & Regulat
006

# SUMMARY OF SAFETY AND EFFECTIVENESS

K971068

## MANUFACTURER IDENTIFICATION:
Medinov-AMP
27 à 31 rue Lucien Langenieux
42335 Roanne FRANCE
JUL - 9 1997

## ESTABLISHMENT REGISTRATION NUMBER (Manufacturer):
9681744

## SPONSOR IDENTIFICATION:
Cheryl Hastings
DePuy, Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, IN 46580

## ESTABLISHMENT REGISTRATION NUMBER (Sponsor):
1818910

## PROPRIETARY NAME:
34mm SCARF Thread-Head Screw

## PRODUCT CLASSIFICATION CODE:
87HWC

## PROPOSED REGULATORY CLASS:
Class II

## DESCRIPTION:
The 34mm SCARF Thread-Head Screw is a threaded bone fixation screw that is 3.0mm in diameter and 34mm in length. It is made of titanium alloy and is cannulated with a threaded head. This screw is an extension of the product line for the SCARF Thread-Head Screw.

## INDICATIONS AND INTENDED USE:
This screw is to be implanted for the fixation of fractures, fusion of a joint or bone reconstruction of the mid-foot, metatarsals and phalanges of the foot.

## PREDICATE DEVICES:
The predicate devices for this screw are the Landos SCARF Thread-Head Screw, the Zimmer Herbert-Whipple Bone Screw and the Osteomed M3 Screw.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

*Ms. Cheryl Hastings
DePuy, Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988

JUL - 9 1997

Re: K971068
34mm SCARF Thread-Head™ Screw
Regulatory Class: II
Product Code: HWC
Dated: May 30, 1997
Received: June 2, 1997

Dear Ms. Hastings:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through

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Page 2 - Cheryl Hastings

542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and Restorative Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K971068

Device Name: 34mm Thread-Head Screw

Indications for Use:

Fixation of fracture, fusion of a joint or bone reconstruction (osteotomy) of the mid-foot, metatarsals and phalanges of the foot.

CONFIDENTIAL

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use ☐ (Per 21 CFR 801.109)

OR

Over-the-Counter Use ☐

(Optional Format 1-2-96)

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