LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW

K013557 · Walter Lorenz Surgical, Inc. · MBI · Nov 16, 2001 · Orthopedic

Device Facts

• Record ID: K013557
• Device Name: LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW
• Applicant: Walter Lorenz Surgical, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Nov 16, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Craniofacial Anchor-Push Screw's are indicated for use to assist resorbable suture in open and endoscopic brow lift procedures.

Device Story

LactoSorb resorbable screw; designed for fixation of soft tissue in brow lift procedures. Device inserted into pre-drilled hole; utilizes auxiliary break-off hex head for installation. Used by surgeons in clinical settings (open or endoscopic). Acts as anchor to assist resorbable suture; provides mechanical fixation during healing process. Benefits patient by eliminating need for permanent hardware removal.

Clinical Evidence

Bench testing only; no clinical data used to determine substantial equivalence.

Technological Characteristics

Resorbable LactoSorb material; screw form factor; auxiliary break-off hex head drive mechanism; manual insertion into pre-drilled hole.

Indications for Use

Indicated for patients undergoing open or endoscopic brow lift procedures requiring resorbable suture assistance.

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

• Craniofacial Anchors (K974136)

Submission Summary (Full Text)

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NOV 1 6 2001

K013537

CORPORATE ARTERS

## SUMMARY OF SAFETY AND EFFECTIVENESS

| Sponsor: | Walter Lorenz Surgical, Inc.<br>(A wholly owned subsidiary of Biomet, Inc.)<br>1520 Tradeport Drive<br>P.O. Box 18009<br>Jacksonville, Florida 32229-8009 |
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- Contact Person: Tracy J. Bickel Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, IN 46581-0587 [phone]
Proprietary Name: LactoSorb® Craniofacial Anchor-Push Screw

Common or Usual Name: Resorbable soft tissue device

Classification Name: Fastener, Fixation, Nondegradable, Soft Tissue (MBI)

Substantially Equivalent Devices: Craniofacial Anchors (K974136)

| Device Description: | The Craniofacial Anchor-Push Screw is a resorbable (LactoSorb®) screw. The<br>device is a screw that is directly inserted into a pre-drilled hole. The Push Screws<br>utilize the same auxiliary break-off hex head as the cleared LactoSorb®<br>Craniofacial Anchors. | | |
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| Intended Use: | The Craniofacial Anchor-Push Screw's are indicated for use to assist resorbable<br>suture in open and endoscopic brow lift procedures. | | |
| Summary of Technologies: | Minor changes were made to the drive mechanism of the screw. In<br>terms of overall design, material, function, as well as intended use,<br>the LactoSorb® Craniofacial Anchor-Push Screw is equivalent to the<br>predicate device. | | |

Non-Clinical Testing: Mechanical testing was completed to determine substantial equivalence.

Clinical Testing: Clinical testing was not used to determine substantial equivalence.

All trademarks are property of Biomet, Inc.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

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SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an abstract symbol that resembles an eagle or a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2001

Walter Lorenz Surgical, Incorporated C/O Ms. Tracey J. Bickel Biomet Orthopedics, Incorporated P. O. Box 587 Warsaw, Indiana 46581-0578

Re: K013557

Trade/Device Name: Lactosorb Cranifacial Anchor-Push Screw Regulation Number: 888.3030 and 872.4880 Regulation Name: Resorbable Soft Tissue Device Regulatory Class: II Product Code: HWC and DZL Dated: October 23, 2001 Received: October 24, 2001

Dear Ms. Bickel:

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.

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Page 2 - Ms. Bickel

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 and ifsting (21 CF read on the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form 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 This letter will and w you've cognification. 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 11 you debire up 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the and additionally 21 CF (1301) 594-4613. 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 nother (Dr Crice a 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,
Liliana A

by A. Ulatowski Timot Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## NOV 1 6 2001

of Page

K013557 510(k) Number (if known): 510(R) Namber (If Rhown)
Device Name: LactoSorb® Craniofacial Anchor-Push Screw Indications for Use:

> The Craniofacial Anchor-Push Screw's are indicated for use to assist resorbable suture in open and endoscopic brow lift procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

Susan Purror

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic ്രം (K) Number _

000008