TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEM

K973145 · Sofamor Danek USA,Inc. · JEY · Nov 19, 1997 · Dental

Device Facts

• Record ID: K973145
• Device Name: TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEM
• Applicant: Sofamor Danek USA,Inc.
• Product Code: JEY · Dental
• Decision Date: Nov 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System is intended for use in any oral-maxilio-cranio-facial surgical procedure, either orthognathic or trauma, wherein rigid or semi-rigid internal fixation is utilized as a means of holding bone fragments together.

Device Story

System consists of titanium plates and screws of various sizes/shapes; used for internal fixation of bone fragments in oral-maxillofacial and craniofacial surgery. Implants provide rigid or semi-rigid stabilization. Used by surgeons in clinical/OR settings. Mechanical fixation device; no electronic or software components.

Clinical Evidence

No clinical data; mechanical test data provided.

Technological Characteristics

Materials: Ti-6Al-4V titanium alloy (ASTM F-136 or ISO equivalent) or commercially pure titanium. Form factor: System of small plates and screws. Sterile or non-sterile supply.

Indications for Use

Indicated for patients undergoing oral-maxillofacial or craniofacial surgical procedures, including orthognathic or trauma surgery, requiring rigid or semi-rigid internal fixation to stabilize bone fragments.

Regulatory Classification

Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

Submission Summary (Full Text)

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K973145

## TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System NOV 1 9 1997 510(k) Summary

August, 1997

- Sofamor Danek USA I. Company: 1800 Pyramid Place Memphis, Tennessee 38132 [phone] TIMESH® Titanium Mini-Softplate/Screw and Micro-II. Product Name: Softplate/Screw System Bone plate and smooth or threaded metallic bone Classification Name: fixation fastener
- The TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw III. System consists of a system of small plate and screws of various sizes and shapes. The implant components are fabricated from Ti-6Al-4V titanium alloy as described by ASTM F-136 or its ISO equivalent. Alternatively, the entire system or parts of it may be made out of commercially pure titanium. The TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System may be supplied either sterile or non-sterile.
- The TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw IV. System is intended for use in any oral-maxilio-craniofacial surgical procedure, either orthognathic or trauma, wherein rigid or semi-rigid internal fixation is utilized as a means of holding bone fragments together.
- The TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw V. System was claimed to be substantially equivalent to commercially available medical devices. Literature concerning these devices was supplied in support of establishing equivalence.

Mechanical test data were provided in support of this notification.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard W. Treharne, Ph.D. Vice President Research and Regulatory Affairs Sofamor Danek USA, Incorporated 1800 Pyramid Place Memphis, Tennessee 38132

NOV 1 9 1997

K973145 Re: TIMESH® Titanium Mini-Softplate and Micro-Trade Name: Soft Plate/Screw System Regulatory Class: II Product Code: JEY Dated: August 20, 1997 Received: August 22, 1997

Dear Dr. Treharne:

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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

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Page 2 - Dr. Treharne

not affect any obligation you might have under sections 531 not arrest any obligation devices under the Electronic enrough sadiation Control provisions, or other Federal laws or requlations.

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 ene regulacion Chercica, Hibbidiang &J Sther 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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System

Indications For Use:

:

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The TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System is intended for use in any oral-maxilio-cranio-facial surgical procedure, either orthognathic intended for ace in ally one semi-rigid internal fixation is utilized as a means of holding bone fragments together.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K973)45

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)

(Optional Format 1-2-96)