BIORCI SCREW

K032224 · Smith & Nephew, Inc. · HWC · Aug 8, 2003 · Orthopedic

Device Facts

• Record ID: K032224
• Device Name: BIORCI SCREW
• Applicant: Smith & Nephew, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Aug 8, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BioRCI® Screw is used for fixation of bone-tendon-bone or soft tissue grafts during Anterior/Posterior Cruciate Ligament (ACL/PCL) reconstruction procedures.

Device Story

BioRCI® Screw is an interference screw used for graft fixation during ACL/PCL reconstruction. Device dimensions range from 7-12mm in diameter and 20-35mm in length. Used by orthopedic surgeons in an operating room setting to secure bone-tendon-bone or soft tissue grafts to bone. The screw provides mechanical fixation to stabilize the graft during the healing process, facilitating ligament reconstruction. It is a modification of the existing BioRCI® Screw line.

Clinical Evidence

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

Technological Characteristics

Interference bone fixation screw; dimensions 7-12mm diameter, 20-35mm length. Material, design, and sterilization methods are identical to the predicate BioRCI® Screw. Mechanical fixation device; no software or energy source.

Indications for Use

Indicated for fixation of bone-tendon-bone or soft tissue grafts during ACL/PCL reconstruction procedures in patients requiring ligament repair.

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

• BioRCI® Screw (K992396)

Submission Summary (Full Text)

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AUG 0 8 2003

K03 2224
page 1 of 2

**EXHIBIT C**

### Endoscopv Division

Smith & Nephew, Inc. 150 Minuteman Road, Andover, MA 01810 U.S.A. Telephone: [phone] Fax: [phone]

# Smith - Nephew

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as

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

### BioRCI® Screw Modification

Date Prepared: 18 July 2003

### 4. Submitter's Name:

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

### B. Company Contact

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

### C. Device Name

Trade Name: Common Name: Classification Name: BioRCI® Screw Bone fixation screw Smooth or metallic bone fixation fastener per 21 CFR § 888.3040

#### D. Predicate Devices

The Smith & Nephew Modified BioRCI® Screw is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device(s) in commercial distribution: BioRCI® Screw, K992396.

#### E. Description of Device

The Modified BioRCI® Screw is an interference screw in the range of 7-12mm in diameter and 20-35mm in length.

> BioRCI® Screw Page 34 of 35

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032224
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#### F. Intended Use

The BioRCI® Screw is used for fixation of bone-tendon-bone or soft tissue grafts during Anterior/Posterior Cruciate Ligament (ACL/PCL) reconstruction procedures.

# G. Comparison of Technological Characteristics

The Modified BioRCI® Screw incorporates a substantially equivalent design, using the same material, manufacturing, fundamental scientific technology, packaging, labeling, sterilization, and intended use as those featured in the currently commercialized BioRCI® Screw line.

# H. Summary Performance Data

In vitro performance testing, material biocompatibility and sterilization validation demonstrate the modified device is safe, substantially equivalent and performs as intended.

> BioRCI® Screw Page 35 of 35

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that appears to be an abstract representation of an eagle or other bird.

Public Health Service

AUG - 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marion W. Gordon, RAC Regulatory Affairs Specialist Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Road Andover, MA 01810

Re: K032224

Trade/Device Name: BioRCI® Screw Modification Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: July 18, 2003 Received: July 21, 2003

Dear Ms. Gordon:

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 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

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### Page 2 - Ms. Marion W. Gordon, RAC

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. 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,

Muriam C. Provost

( Celia M. Witten, Ph.D., M.D. 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):

Ko32224

Device Name: ___ BioRCI® Screw Modification

Indications For Use:

The BioRCI® Screw is used for fixation of bone-tendon-bone or soft tissue grafts during Anterior/Posterior Cruciate Ligament (ACL/PCL) reconstruction procedures.

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K032224

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

BioRCI® Screw Page 10 of 35