TIMESH SYSTEM

K974017 · Sofamor Danek USA,Inc. · HRS · Jan 16, 1998 · Orthopedic

Device Facts

• Record ID: K974017
• Device Name: TIMESH SYSTEM
• Applicant: Sofamor Danek USA,Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Jan 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TIMESH System is intended for use in any oral-maxillo-cranio-facial surgical reconstructive procedure, either orthognathic or trauma, wherein rigid or semirigid internal fixation is utilized as a means of holding bone fragments together. Alternatively, the TIMESH System is also indicated for use in reinforcing weak bony tissues in orthopaedic surgical procedures such as pelvic reconstruction. acetabular reconstruction, and cement restriction. This product is not intended for spinal use.

Device Story

TIMESH System comprises metallic mesh, wires, plates, and screws used for internal bone fixation. Device provides rigid or semirigid stabilization of bone fragments during oral-maxillo-cranio-facial reconstructive or trauma surgery. Also used for reinforcing weak bony tissues in orthopaedic procedures like pelvic or acetabular reconstruction and cement restriction. Operated by surgeons in clinical/surgical settings. System components are implanted to hold bone fragments in place or provide structural reinforcement, facilitating bone healing and reconstruction. Not intended for spinal applications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Components fabricated from Ti-6Al-4V titanium alloy (ASTM F-136) or commercially pure titanium (ASTM F-67). System includes mesh, wire, plates, and screws of various sizes/shapes. Supplied sterile or non-sterile. Mechanical fixation device; no energy source or software.

Indications for Use

Indicated for patients undergoing oral-maxillo-cranio-facial reconstructive surgery (orthognathic or trauma) requiring rigid/semirigid internal bone fixation, or patients requiring reinforcement of weak bony tissues in orthopaedic procedures (pelvic/acetabular reconstruction, cement restriction). Contraindicated for spinal use.

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.

Submission Summary (Full Text)

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K9 7 401 7

JAN 16 1998

## TIMESH® System 510(k) Summary

K974017 January, 1998

- Company: 1.
Sofamor Danek USA 1800 Pyramid Place Memphis, Tennessee 38132 [phone]

- TIMESH® System Product Name: II.
Surgical mesh, smooth or threaded metallic bone Classification Name: fixation fastener and/or intraosseous fixation wire.

- The TIMESH® System consists of a system of mesh, wire, plates and screws of 111. various sizes and shapes. The implant components are fabricated from Ti-6Altitanium alloy as described by ASTM F-136 or its ISO equivalent. 4V Alternatively, the entire system or parts of it may be made out of commercially The TIMESH pure titanium described by ASTM F-67 or its ISO equivalent. System may be supplied either sterile or non-sterile.
- The TIMESH System is intended for use in any oral-maxillo-cranio-facial surgical IV. reconstructive procedure, either orthognathic or trauma, wherein rigid or semirigid internal fixation is utilized as a means of holding bone fragments together. Alternatively, the TIMESH System is also indicated for use in reinforcing weak bony tissues in orthopaedic surgical procedures, such as pelvic reconstruction, acetabular reconstruction, and cement restriction. This product is not intended for spinal use.
- The TIMESH System was claimed to be substantially equivalent to commercially V. available medical devices.

C 1998 Sofamor Danek

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 6 1998

Richard W. Treharne, Ph.D. · Vice President Research and Regulatory Affairs 1800 Pyramid Place 38132 Memphis, Tennessee

K974017 Re: TIMESH® System Requlatory Class: II Product Codes: HRS, HWC, GXR, and EZX Dated: October 20, 1997 Received: October 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 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 In addition, FDA may publish further announcements action. 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 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Richard W. Treharne, Ph.D.

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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Cella M. Witten, Ph.D.,

la 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 January, 1998

510(k) Number (if known):

TIMESH® System Device Name:

Indications For Use:

The TIMESH System is intended for use in any oral-maxillo-cranio-facial surgical reconstructive procedure, either orthognathic or trauma, wherein rigid or semirigid internal fixation is utilized as a means of holding bone fragments together. Alternatively, the TIMESH System is also indicated for use in reinforcing weak bony tissues in orthopaedic surgical procedures such as pelvic reconstruction. acetabular reconstruction, and cement restriction. This product is not intended for spinal use.

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Concurrence of GDRH, Office of Device Evaluati ੇ ਵ OR Over-The-Counter Use Prescription Use (Per 21 CFR 801.109)