BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET

K050497 · Linvatec Corp. · HWC · Mar 25, 2005 · Orthopedic

Device Facts

• Record ID: K050497
• Device Name: BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET
• Applicant: Linvatec Corp.
• Product Code: HWC · Orthopedic
• Decision Date: Mar 25, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm, violet, provide 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; composed of absorbable Poly (L-Lactic Acid) homopolymer; violet colorant added. Device functions as a mechanical fastener for soft tissue graft fixation in ACL and PCL reconstruction. Used by orthopedic surgeons in clinical/OR settings. Modification from predicate involves reduced major diameter. Device provides secure graft attachment to bone, facilitating healing; material is absorbable, eliminating need for secondary removal surgery.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use comparisons to the predicate device.

Technological Characteristics

Cannulated bone screw; material: Poly (L-Lactic Acid) (PLLA) homopolymer; violet colorant; sterile, single-use; dimensions: 8 x 35mm and 8 x 40mm; mechanical fixation principle.

Indications for Use

Indicated for tibial interference fixation of soft tissue grafts during ACL and PCL reconstruction surgery.

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

• BioScrew® XtraLok™ (K013131)

Submission Summary (Full Text)

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### MAR 2 5 2005

# PROPRIETARY INFORMATION – LINVATEC CORPORATION

February 8, 2005

## 510(k) Submission

### Summary of Safety and Effectiveness

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR In accordance with the requirements of submitting a Special 510(k) Summary of Safety and 007.92, Linvatec Corporation is net 05 - 35mm-Violet and BioScrew® XtraLok® 8 x 40mm-Violet, 510(k) Number Koro49.7

#### Submitter A.

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

### Company Contact B.

Elizabeth Paul Manager, Regulatory Affairs Telephone [phone] [phone] FAX

### C. Device Name

Trade Name: BioScrew® XtraLok® 8 x 35mm-Violet and BioScrew® XtraLok® 8 x 40mm-Violet

Bioabsorbable Interference Screw Common Name:

Classification Names: Fastener, Fixation, Biodegradable, Soft Tissue

| Proposed Class/Device: | Class II |
|------------------------|----------|
| Product Code | HWC |

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### PROPRIETARY INFORMATION - LINVATEC CORPORATION

February 8, 2005 510(k) Submission BioScrew® XtraLok® 8 x 35mm and 8 x 40mm,violet 510(k) # _____________________________________________________________________________________________________________________________________________________________________

### Predicate/Legally Marketed Devices D.

BioScrew® XtraLok™ 510(k)# K013131 Linvatec Corporation

#### Device Description E.

The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm, violet are cannulated, sterile, single-use bone screws made of an absorbable homopolymer derived from Poly (L-Lactic Acid).

Two sizes will be availablé for the device, 8 x 35mm and 8 x 40mm. The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm, violet, differ from the existing Linvatec BioScrew® XtraLok™ in that the major diameter is smaller. The violet colorant contained in this device, has been cleared for this product code and intended use by the FDA via color petition 8C0255 dated January 28, 1998.

The modification does not affect the device's intended use, fundamental scientific technology or performance specifications.

#### F. Intended Use

The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm,violet, provide tibial interference fixation of a soft tissue graft for ACL and PCL reconstruction.

### Substantial Equivalence G.

The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm, violet, are substantially equivalent in design, materials and intended use to the BioScrew@ XtraLok™. The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm, violet, do not raise any new issues of safety or effectiveness when compared to this predicate device.

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MAR 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elizabeth Paul Manager, Regulatory Affairs Linvatec Corp. 11311 Concept Boulevard. Largo, Florida 33773-4908

Re: K050497

Trade/Device Name: Bioscrew® XtraLokTM Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 15, 2005 Received: February 28, 2005

Dear Ms. Paul:

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. Elizabeth Paul

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/industry/support/index.html

Sincerely yours,

Hupk Rludu

iriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# PROPRIETARY INFORMATION - LINVATEC CORPORATION

# Indications for Use

12050497

510(k) Number (if known):_

Device Name: BioScrew® XtraLok® 8 x 35mm-Violet and BioScrew® XtraLok® 8 x 40mm-Violet

Indications for Use:

The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm, violet provide tibial The Drosciow of Atranse of a soft tissue graft for ACL and PCL reconstruction.

Prescription Use_X__ OR (Part 21 CFR 801 subpart D)

Over-the-Counter Use______ (Part 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)

Hpp. Rludi

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

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510(k) Number K050497