PLC SCREW

K051310 · Smith & Nephew, Inc. · HWC · Jul 26, 2005 · Orthopedic

Device Facts

• Record ID: K051310
• Device Name: PLC SCREW
• Applicant: Smith & Nephew, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Jul 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smith & Nephew PLC Screw is indicated for fixation of bone-tendon-bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.

Device Story

The PLC Screw is a cannulated, sterile, single-use bone fixation fastener used in orthopedic reconstruction surgery. It is composed of an osteoconductive, biodegradable material (poly DL-lactide-co-glycolide and calcium carbonate). The device is used by surgeons to secure grafts during ACL/PCL reconstruction procedures. It functions as a mechanical fixation device to hold grafts in place while facilitating an osteoconductive response in vivo. The device is intended for prescription use.

Clinical Evidence

Evidence includes product validation testing, in vitro degradation testing, and an in-vivo ovine study. Results demonstrated that the PLC Screw is biocompatible, degrades in a timely manner, elicits an osteoconductive response in vivo, and provides fixation equivalent to the BioRCI Screw.

Technological Characteristics

Cannulated, sterile, single-use bone screw. Material: poly DL-lactide-co-glycolide and calcium carbonate. Osteoconductive and biodegradable. Designed for bone fixation.

Indications for Use

Indicated for fixation of bone-tendon-bone or soft tissue grafts during ACL/PCL reconstruction.

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

• HAPLA Interference Screw (K002274)
• BioRCI Screw (K992396)

Submission Summary (Full Text)

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K051310 page f2

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

978 749 1000 978 749 1599 fax www.smith-nephew.com JUL 2 6 2005

>< We are smith&nephew

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

over of of the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substanual equivalence is based.

PLC Screw

Date Prepared: May 16, 2005

### A. Submitter's Name:

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

## B. Company Contact

Bill McCallum Senior Regulatory Specialist T 508 261 3658 F 508 261 3620

### C. Device Name

| Trade Name: | PLC Screw |
|----------------------|----------------------------------------------------|
| Common Name: | Screw, Fixation, Bone |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |

### D. Predicate Devices

The Smith & Nephew PLC Screw is substantially equivalent in Intended Use and Fundamental Scientific The onliner & Nephow agaily marketed device in commercial distribution:

- HAPLA Interference Screw K002274 .
- BioRCI Screw K992396

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page \frac{2}{f^2}

#### Description of Device E.

Description of Device The Smith & Nephew I DC Serew 18 an more and reconstruction surgery.

### Intended Use

IThe Smith & Nephew PLC Screw is indicated for fixation of bone-tendon-bone or soft tissue grafts
The Smith & Nephew PLC Seree & States Science (ACI) (DCL) reconstruction The Smith & Neptiew I LC Seren Truciate Ligament (ACL/PCL) reconstruction.

### Comparison of Technological Characteristics F.

Screw and the PLC Screw is essentially identical to the HAPLA Interference Screw and the The Smith & Nephew PLC Screw is essemaly idented to the PLC Scew is a canulated, sterile, BioRCI Screw described in K002274 and R772376 Leoped roly - 2274
single use bone screw, made of an ostecconductive biodegradable material, poly DL-lactide-co-glycolide and calcium carbonate

#### Summary Performance Data G.

Results of product validation testing, in vitro degradation testing, and an in-vivo ovine study conclude that Results of product valuation testibits equivalent fixation to the BioRCI Screw. In addition,
the PLC Screw is biocompatible and exhibits equivalent fixation to the Biokeligi the PLC Screw is blocompanible and canable of a timely manner, and elicits an osteoconductive response in vivo.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol with three intertwined lines, representing health and medicine. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Public Health Service

JUL 26 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Bill McCallum Sr. Regulatory Specialist Endoscopy Division Smith & Nephew, Inc. 150 Minuteman Road Andover, Massachusetts 01810

Re: K051310

Trade/Device Name: PLC Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 18, 2005 Received: May 19, 2005

Dear Mr. McCallum:

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 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 – Mr. Bill McCallum

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w you've organ finding of substantial equivalence of your device to a legally premailed 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 If you desire spocitie at novier 9 % [phone]. Also, please note the regulation entitled, Connact the Office of Count to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,

Stupt Elwda

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | K051310 |
|---------------------------|---------------------|
| | Indications for Use |

Device Name: PLC Screw

Indications for Use:

The Smith & Nephew PLC Screw is indicated for fixation of bone-tendon-bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ ્ Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stpt Clurlu
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

KOSIBID 510(k) Number_