SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW

K040542 · Smith & Nephew, Inc. · HWC · Aug 19, 2004 · Orthopedic

Device Facts

• Record ID: K040542
• Device Name: SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW
• Applicant: Smith & Nephew, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Aug 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smith & Nephew GTS Sleeve and GTS Tapered Screw are indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.

Device Story

Device consists of two components: a sleeve and a tapered screw. Used in cruciate ligament reconstruction surgery to fixate soft tissue grafts within a surgically created tibial tunnel. Sleeve manages, protects, and separates graft tendon bundle while creating a central path for the tapered screw. Tapered screw is inserted into the sleeve, forcing a larger surface area of the tendons against the tibial tunnel wall to achieve fixation. Operated by surgeons in an OR setting. Benefits include secure graft fixation during ligament reconstruction.

Clinical Evidence

Bench testing only. Evidence includes in vitro performance testing, material biocompatibility, and sterilization validation to support substantial equivalence.

Technological Characteristics

Multi-channeled, single-construct sleeve and tapered screw system. Materials include bioresorbable and non-bioresorbable options. EO sterilized. Single patient use. Mechanical fixation principle.

Indications for Use

Indicated for fixation of soft tissue grafts during cruciate ligament reconstruction in patients requiring such surgical intervention.

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

• Intrafix™ Tibial Sheath and Intrafix™ Tibial Tapered Screw (K983560)
• BioRCT® Screws (K032224)
• BioRCT® Screws (K992396)

Submission Summary (Full Text)

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K040542 pg. 1 of 2

# AUG 1 9 2004

We are smith&nepher

Endoscopy Division Smith & Nephew, Inc 150 Minuteman Road Andover, MA 01810

1978-749-1371 F 978-149-1443 www.smith-nephew.com

# SECTION IV 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

The Smith & Nephew GTS Sleeve and GTS Tapered Screw Date Prepared: 1 March 2004

# A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810

# B. Company Contact

Marion W. Gordon, RAC Regulatory Affairs Specialist Fax: [phone] Phone: [phone]

#### C. Device Name

| Trade Name: | The Smith & Nephew GTS Sleeve and GTS Tapered Screw |
|----------------------|--------------------------------------------------------------------|
| Common Name: | Fixation, bone, screw |
| Classification Name: | Smooth or metallic bone fixation fastener<br>per 21 CFR § 888.3040 |

# D. Predicate Devices

The Smith & Nephew GTS Sleeve and GTS Tapered Screw are substantially equivalent to Intrafix™ Tibial Sheath and Intrafix™ Tibial Tapered Screw, manufactured by Innovasive Devices, Inc. (acquired by Johnson & Johnson, November 1999) and found substantially equivalent on 28 January 1999 under K983560. In addition, the proposed GTS Tapered Screw is substantially equivalent to Smith & Nephew, Inc. K032224 (SE 08/05/03) and K992396 (SE 01/12/00) BioRCT® Screws.

# E. Description of Device

The Smith & Nephew GTS Sleeve and GTS Tapered Screw consist of two (2) components, the sleeve and screw. The sleeve manages, protects, and separates the graft tendon bundle and creates a central path for concentric placement of the tapered screw, which forces a larger surface area of the tendons against the tibial tunnel wall within a surgically created tunnel.

GTS Page 032 of 076

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> We are smith&nephow

#### SECTION IV cont.

# F. Intended Use

The Smith & Nephew GTS Sleeve and GTS Screw are indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.

# G. Comparison of Technological Characteristics

Comparison of Technological GTS Sleeve and GTS Tapered Screw and the I he proposed Shillth & Nephew OTB Bloove and Ore of Screw share the same indications for Intrallx ... Tiolal Sheath and mittallis - rapers - Both employ a multi channeled, single construct device (one channel for central screw placement) to manage, protect and construct device (one channel for ochara sthe ... The tapered screw creates the final fixation within a created tibial tunnel. The bioresorbable GTS Tapered Screw and nonwithin a created troial tunnol. The similar geometries and range of sizes. Each device is packaged as single patient use and EO sterilized.

# H. Summary Performance Data

Suith & Nephew GTS Sleeve and GTS Tapered Screw utilize design features and Shifth & Nephow OFD breat are redicate device. The in vitro performance testing, material biocompatibility and sterilization validation demonstrate the device is safe, matorial of over intended, and supports a decision of substantial equivalence.

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Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an abstract human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 9 2004

Ms. Debra Connors Regulatory Affairs Specialist Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810

Re: K040542

Trade/Device Name: GTS Sleeve and GTS Tapered Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: June 9, 2004 Received: June 10, 2004

Dear Ms. Connors:

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 for work in 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 application (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 such 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); 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.

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# Page 2 - Ms. Debra Connors

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Wilkerson
for
Julie M. Witten, Ph.D., M.D.

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

Enclosure

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# Indications for Use

510(k) Number (if known):

K040542

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Smith & Nephew GTS Sleeve and GTS Tapered Screw are indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.

fo Mark A. Mellema
Division Sign Off

Division Sion ... Division of General, Restorative, and Neurological Devices

**510(k) Number** K040542

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

110 Over-The-Counter Use (Per 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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