MODIFICATION TO BILOK ST SCREW

K071115 · Biocomposites, Ltd. · HWC · May 17, 2007 · Orthopedic

Device Facts

• Record ID: K071115
• Device Name: MODIFICATION TO BILOK ST SCREW
• Applicant: Biocomposites, Ltd.
• Product Code: HWC · Orthopedic
• Decision Date: May 17, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bilok® ST Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures. The Bilok® ST Screw is used to provide suspensary fixation during femoral fixation in ACL reconstruction using double looped (semitendinosis/gracilis) or quadruple (semitendinosis) graft.

Device Story

Cannulated, sterile, single-use bone screw; composite of calcium phosphate and poly L-lactic acid (PLLA). Used in orthopedic surgery for femoral suspensory fixation during ACL reconstruction. Provides mechanical graft fixation. Operated by orthopedic surgeons in clinical/OR settings. Benefits patient by securing graft during ligament reconstruction.

Clinical Evidence

Bench testing only.

Technological Characteristics

Cannulated bone screw; composite material of calcium phosphate and poly L-lactic acid (PLLA); sterile; single-use.

Indications for Use

Indicated for patients undergoing anterior cruciate ligament (ACL) reconstruction requiring femoral suspensory fixation using double-looped (semitendinosus/gracilis) or quadruple (semitendinosus) 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.

Submission Summary (Full Text)

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K07115 page 1/2

## 510(k) SUMMARY

# Bilok® ST Screw

MAY 1 7 2007

Biocomposites Ltd Applicant Keele Science Park Keele Staffordshire England ST5 SNL

Contact Person Mr Simon Fitzer Tel: [phone] [phone] Fax Email: [e-mail]

| Classification Name: | Screw, fixation, bone |
|------------------------|-----------------------|
| Common/Usual Name: | Bone screw |
| Trade/Proprietary Name | Bilok® ST Screw |
| Product Code | HWC |
| CFR Section | 21CFR888.3040 |

### Device Description

The Bilok® ST Screw is a cannulated, sterile, single use bone screw manufactured from a composite mix of calcium phosphate and poly L-lactic acid (PLLA).

#### Intended Use / Indications

The Bilok® ST Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures.

The Bilok® ST Screw is used to provide suspensary fixation during femoral fixation in ACL reconstruction using double looped (semitendinosis/gracilis) or quadruple (semitendinosis) graft.

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## Summary of Technology

The Bilok® ST Screw has the same technological characteristics as the legally marketed predicate device and any differences do not raise any concerns regarding safety and effectiveness.

## Non Clinical Testing

Documentation provided demonstrates that the Bilok® ST Screw is substantially equivalent to the legally marketed predicate device and any differences do not raise any concerns regarding safety and effectiveness.

### Substantial Equivalence

Documentation provided demonstrates that the Bilok® ST Screw is substantially equivalent to the legally marketed predicate device and any differences do not raise any concerns regarding safety and effectiveness.

### Safety and Performance

Documentation provided demonstrates that the Bilok® ST Screw is substantially equivalent to the legally marketed predicate device and any differences do not raise any concerns regarding safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biocomposites Ltd % Mr. Simon Fitzer Quality and Regulatory Affairs Manager Keele Science Park Keele, Staffordshire England, ST5 5NL

MAY 17 2007

Re: K071115

Trade/Device Name: Bilok® ST Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: April 12, 2007 Received: April 20, 2007

Dear Mr. Fitzer:

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 – Mr. Simon Fitzer

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" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 vours.

Spoubare buehr

Mark N. Melkerson 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): ____________________________________________________________________________________________________________________________________________________

Device Name:

Bilok® ST Screw

Indications For Use:

The Bilok® ST Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures.

The Bilok®ST Screw is used to provide suspensary fixation during femoral fixation in ACL reconstruction using double looped (semitendinosis/gracilis) or quadruple (semitendinosis) graft.

Prescription Use (Part 21 CFR 801 Subpart D)

OR

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)

Sarhare Buchn

Division of General, Restorative. and Neurological Devices

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510(k) Number K071115