TIMESH SELF DRILLING SCREW

K062348 · Medtronic Neurosurgery · HWC · Sep 8, 2006 · Orthopedic

Device Facts

• Record ID: K062348
• Device Name: TIMESH SELF DRILLING SCREW
• Applicant: Medtronic Neurosurgery
• Product Code: HWC · Orthopedic
• Decision Date: Sep 8, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• 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 semi-rigid 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 tissue 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, wire, screws, and plates; used for rigid or semi-rigid internal bone fixation. Applied in oral-maxillo-cranio-facial reconstructive procedures (trauma/orthognathic) and orthopaedic surgeries (pelvic/acetabular reconstruction, cement restriction). Operated by surgeons in clinical/OR settings. Provides mechanical stabilization of bone fragments or reinforcement of weak bony tissue. Not for spinal use.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Metallic bone fixation system consisting of mesh, wire, screws, and plates. Materials and fundamental technology are identical to previously cleared predicate devices.

Indications for Use

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

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

• TiMesh® System (K974017)
• TiMesh® System (K923419)

Submission Summary (Full Text)

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## KO62348

## 4. 510(k) Summary

SEP - 8 2006

US

This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.87.

| Establishment Registration Number: | 2021898 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Address of Manufacturer: | Medtronic Neurosurgery<br>125 Cremona Drive<br>Goleta CA, 93117<br>[phone] ext. 1773<br>Fax: [phone] |
| Contact Person: | Jeffrey Henderson |
| Date: | August 3, 2006 |
| Trade or Proprietary Name: | TiMesh® System |
| Common usual or Classification Name: | Single/multiple component metallic bone fixation<br>appliances and accessories (888.3030) |
| Predicate Device Identification: | TiMesh® System (K974017, K923419) |

Description: The device consists of a system of mesh, wire, screws, and plates of various sizes and shapes to be used for rigid or semi-rigid internal fixation.

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 semi-rigid 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 tissue in orthopaedic surgical procedures such as pelvic reconstruction, acetabular reconstruction, and cement restriction. This product is not intended for spinal use.

Intended Use of predicate device(s): The TiMesh System is intended for use in any oralmaxillo-cranio-facial surgical reconstructive procedure, either orthognathic or trauma, wherein rigid or semi-rigid 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 tissue in orthopaedic surgical procedures such as pelvic reconstruction, acetabular reconstruction, and cement restriction. This product is not intended for spinal use.

Technological comparison: Medtronic Neurosurgery submits that the materials of fabrication, intended use, and the fundamental scientific technology of the TiMesh System is the same as the previously reviewed and cleared TiMesh System. Based upon the summary above, Medtronic Neurosurgery determines substantial equivalence, safety, and

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Ka2348

efficacy of the TiMesh System products compared to the predicate and currently marketed devices.

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Image /page/2/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 eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is composed of thick, curved lines, and the text is in a simple, sans-serif font. The overall design is clean and professional.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAR - 8 2012

Medtronic Neurosurgery % Mr. Jeffrev Henderson Vice President, Quality & Regulatory Affairs 125 Cremona Drive Goleta, California 93117

Re: K062348 Trade/Device Name: TiMesh® System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: August 3, 2006 Received: August 16, 2006

Dear Mr. Henderson:

This letter corrects our substantially equivalent letter of September 8, 2006.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical

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device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.goy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A. Millerm

Mark N. Melkerson Director Division of Surgical, Orthopedic & Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## II. Statement of Indications for Use

510(k) Number (if known):

K062348

Device Name: TiMesh® System

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.

Prescription Use > (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

BBKind

(Division & . . Oft) Division of argical, Orthopedic, and Restorative Devices

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510(k) Number K062348 44