RCI FIXATION SCREWS

K980841 · Smith & Nephew, Inc. · HWC · May 20, 1998 · Orthopedic

Device Facts

• Record ID: K980841
• Device Name: RCI FIXATION SCREWS
• Applicant: Smith & Nephew, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: May 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

RCI Fixation Screws are used for interference fixation of Bone-Tunnel-Bone or Hamstring grafts in anterior or posterior cruciate ligament reconstruction.

Device Story

RCI Fixation Screws are rounded head interference screws used for graft fixation in ACL/PCL reconstruction. Device features constant thread profile for maximum engagement; available in 7-9 mm diameters and 25-50 mm lengths. Manufactured from titanium. Used by orthopedic surgeons in clinical/surgical settings. Provides mechanical fixation of bone-tunnel-bone or hamstring grafts to bone tunnels, facilitating ligament healing and stability.

Clinical Evidence

Bench testing only. Laboratory testing confirmed suitable fixation strength for use as interference screws.

Technological Characteristics

Titanium interference screws; rounded head design; constant thread profile; diameters 7-9 mm; lengths 25-50 mm. Sterilized via gamma irradiation.

Indications for Use

Indicated for patients undergoing anterior or posterior cruciate ligament reconstruction requiring interference fixation of Bone-Tunnel-Bone or Hamstring grafts.

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

• Arthrex Extra Long Screw (K915424)
• RCI Screw (K945687)

Submission Summary (Full Text)

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MAY 20 1998

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# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is :

ર 980841

This summary was prepared on March 2,1998

### A. Submitter

Smith & Nephew, Inc., Endoscopy Division 130 Forbes Boulevard Mansfield, MA 02048

# Company Contact B.

Demetrios Tsakonas Clinical/Regulatory Specialist

## C. Device Name

RCI Fixation Screws Proprietary Name:

Common Name: Screw, Fixation, Bone, Orthopedics

Screw: 87HWC Classification Name:

The Orthopedics Device Panel has classified Screw, Classification: Surgical as a Class II device. (21 CFR § 878.4930)

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# Predicate/Legally Marketed Devices D.

Arthrex Extra Long Screw (K915424): Arthrex 3050 NORTH HORSESHOE DRIVE SUITE 200 NAPLES, FL 33942

RCI Screw (K945687): Smith & Nephew Inc., Donjoy Division 2777 LOKER AVE. WEST CARLSBAD, CA 92008

### E. Device Description

RCI Fixation Screws are rounded head interference screws which include diameters from 7 to 9 mm and a range of lengths from 25 mm to 50 mm. To allow for maximum amount of thread engagement, the thread profile is constant throughout the entire length of the screw. Except for direction of the threads, the Reverse Thread RCI screw is identical to the current RCI screw.

# F. Performance

# Bench Testing

RCI Fixation screws have been tested in the laboratory and found to have suitable fixation strength for use as interference screws.

### G. Intended Use

RCI Fixation Screws are used for interference fixation of Bone-Tunnel-Bone or Hamstring grafts in anterior or posterior cruciate ligament reconstruction.

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# Substantial Equivalenc H.

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| Attribute | Current Product<br>RCI Fixation Screws | Substantially Equivalent Product<br>RCI Screw | Substantially Equivalent Product<br>Arthrex Extra Long Screw |
|---------------|-------------------------------------------|-----------------------------------------------|--------------------------------------------------------------|
| Indication | Graft Fixation for ACL/PCL Reconstruction | Graft Fixation for ACL Reconstruction | Graft Fixation for ACL/PCL Reconstruction |
| Dimensions | Length: .985" - 1.97" | Length: .985" | Length: 1.18" - 1.97" |
| | Major Diameter: .276" - .355" | Major Diameter: .276" - .355" | Major Diameter: .315" - .355" |
| Material | Titanium | Titanium | Titanium |
| Sterilization | Gamma Irradiation | Gamma Irradiation | NA |
| Labeling | Sterile/Non-Sterile | Sterile/Non-Sterile | NA |

Applicant

Signature

Date

3/28

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Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a traditional symbol of medicine, with three intertwined snakes and a staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 20 1998

Mr. Demetrios Tsakonas Clinical/Regulatory Specialist Smith and Nephew, Inc. 130 Forbes Boulevard 02048 Mansfield, Massachusetts

K980841 Re: Rounded Cannulated Inside-out (RCI) Trade Name: Fixation Screws Requlatory Class: II Product Code: HWC Dated: March 2, 1998 Received: March 4, 1998

Dear Mr. Tsakonas:

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 Requlations, 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 read 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 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 – Mr. Demetrios Tsakonas

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,

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

Enclosure

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# 510 (k) Number (If Known): K 9 80 84 1

Device Name: RCI Fixation Screws

Indications for Use:

RCI Fixation Screws are used for interference fixation of Bone-Tunnel-Bone or Hamstring grafts in anterior or posterior cruciate ligament reconstruction.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Pcoello
(Division Sign-Off)

Division of General Restorative Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

or Over-The-Counter Use ______________________________________________________________________________________________________________________________________________________