BIOSCREW XTRALOK

K013131 · Linvatec Corp. · HWC · Jun 11, 2002 · Orthopedic

Device Facts

• Record ID: K013131
• Device Name: BIOSCREW XTRALOK
• Applicant: Linvatec Corp.
• Product Code: HWC · Orthopedic
• Decision Date: Jun 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BioScrew® XtraLok™ interference screw provides tibial interference fixation of a soft tissue graft for ACL and PCL reconstruction.

Device Story

BioScrew XtraLok is a cannulated, sterile, single-use bone screw; manufactured from absorbable Poly (L-Lactic Acid) homopolymer. Device used by orthopedic surgeons in clinical settings for ACL and PCL reconstruction. Function involves providing tibial interference fixation of soft tissue grafts. Design features include angled proximal face and tapered proximal threaded body to enhance fixation. Available in six sizes (9, 10, 11mm diameters; 35 or 40mm lengths). Device is implanted during surgery to secure graft, facilitating healing and joint stability.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material comparison to predicate device.

Technological Characteristics

Cannulated bone screw; material: Poly (L-Lactic Acid) (PLLA) homopolymer; sterile, single-use; dimensions: 9-11mm diameter, 35-40mm length; design: angled proximal face, tapered proximal threaded body; fixation principle: mechanical interference.

Indications for Use

Indicated for patients requiring tibial interference fixation of soft tissue grafts during ACL and PCL reconstruction procedures.

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

• Linvatec BioScrew (K973758)

Submission Summary (Full Text)

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K°/3/3/

JUN 1 1 2002

3/12/02

# SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the BioScrew® XtraLok™ Bioabsorbable Interference Screw 510(k) Number K013131

#### A. Submitter

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

## Company Contact B.

Laura D. Seneff, RAC Manager, Regulatory Affairs [phone] Telephone [phone] FAX

## C. Device Name

Trade Name: BioScrew® XtraLok™

Common Name: Bioabsorbable Interference Screw

Classification Names: Fastener, Fixation, Biodegradable, Soft Tissue

Proposed Class/Device: Class II Product Code MAI

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page 1 of 2

Summary of Safety and Effectiveness BioScrew® XtraLok Bioabsorbable Interference Screw 510(k) # K013131 3/12/02 Page 2 of 2

### D. Predicate/Legally Marketed Devices

Linvatec BioScrew® 510(k)# K973758

### ப் Device Description

The BioScrew Xtralok™ is a cannulated, sterile, single-use bone screw made of an absorbable homopolymer derived from Poly (L-Lactic Acid).

The BioScrew XtraLok will be available in 6 sizes: 9, 10, and 11mm diameters by 35 or 40mm lengths. The proximal face is angled from the axis of the BioScrew, and the proximal region of the threaded body tapers to a larger diameter.

## F. Intended Use

The BioScrew XtraLok provides tibial interference fixation of a soft tissue graft for ACL and PCL reconstruction.

## G. Substantial Equivalence

The BioScrew XtraLok is substantially equivalent in design, materials and intended use to the Linvatec BioScrew interference screw. The BioScrew XtraLok interference screw does not raise any new issues of safety or effectiveness when compared to this predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of what appears to be an eagle or bird-like figure, composed of three curved lines that suggest movement or flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 11 2002

Ms. Laura D. Seneff, RAC Manager, Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

Re: K013131

Trade/Device Name: BioScrew XtraLok™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 12, 2002 Received: March 13, 2002

Dear Ms. Seneff:

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 - Ms. Laura D. Seneff, RAC

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). 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 Mllhums

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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9/18/01

510(k) Number (if known): K0/3/3/

Device Name: Bioabsorbable Interference Screw

Indications for Use:

The BioScrew® XtraLok™ interference screw provides tibial interference fixation of a soft tissue graft for ACL and PCL reconstruction.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use\$\frac{2}{7}\$ OR
Over-the-Counter Use No
(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Mark M. Melhem

Division of General, Restorative and Neurological Devices

510(k) Number _