CRANIOFACIAL ANCHORS

K974136 · Biomet, Inc. · MBI · Jan 30, 1998 · Orthopedic

Device Facts

• Record ID: K974136
• Device Name: CRANIOFACIAL ANCHORS
• Applicant: Biomet, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Jan 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Craniofacial Anchors are indicated for use to assist resorbable suture in open and endoscopic brow lift procedures.

Device Story

Craniofacial Anchors are bioresorbable fixation devices used in brow lift procedures; designed to assist resorbable sutures in anchoring soft tissue to bone. Device is placed into a pre-drilled, tapped bone hole. Manufactured from LactoSorb, a synthetic copolymer of lactic and glycolic acids; material undergoes hydrolysis in vivo, resorbing completely by 12 months. Used by surgeons in clinical settings; provides mechanical support for soft tissue reattachment during healing. Benefits include biocompatibility and elimination of need for permanent hardware removal.

Clinical Evidence

No clinical data specific to the anchor device provided in the summary; safety and effectiveness are supported by historical clinical trial data for the LactoSorb material used in other applications (ligating clips) and animal studies demonstrating complete resorption by 12 months.

Technological Characteristics

Material: LactoSorb (synthetic copolymer of lactic and glycolic acids). Principle: Bioresorbable mechanical anchor for soft tissue reattachment. Form factor: Designed for insertion into pre-drilled, tapped bone holes. Strength: Maintains integrity for soft tissue reattachment and fracture healing before undergoing hydrolysis.

Indications for Use

Indicated for patients undergoing open or endoscopic brow lift procedures requiring soft tissue anchoring via resorbable suture. Not for use in the mandible or full load-bearing 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.

Submission Summary (Full Text)

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K974136

## 510(k) Summary of Safety and Effectiveness

SUBMITTER: Biomet, Inc. Airport Indutrial Park P. O. Box 587 Warsaw, IN 46581-0587

CONTACT PERSON: Mary L. Verstynen [phone] ext. 1343

PRODUCT CODE: 79 GAN Device Name: Craniofacial Anchors

## SUMMARY

The Craniofacial Anchors are indicated for use with resorbable suture in open and endoscopic brow lift procedures. The device is placed into a preditiled, tapped bone hole and assists the suture in anchoring soft tissue. These devices are not designed for use in the mandible and/or full load bearing procedures.

The devices are made of LactoSorb® material, which based on animal studies, completely resorbs by 12 months In Vivo. The devices are made of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic (PLA/PGA) acid copolymer degrades and resorbs In Vivo by hydrolysis to lactic and glycolic acids which are then metabolized by the body. The safety of PLAPGA material has been well documented since the early 1970's when FDA first approved the use of resorbable PLA/PGA sutures. The exact same LactoSorb® material has been implanted in humans for over 10 years in the form of a ligating clip and safety and effectiveness has been studied in two different clinical trials. The LactoSorb® material has been found to be biocompatible in both soft and hard bone tissue and maintains its strength for soft tissue reattachment and fracture healing.

As demonstrated in this submission, the Craniofacial Anchors are safe and effective for use in brow lift procedures.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three wavy lines extending from the head, resembling hair or a flowing garment. The figure is positioned to the right of a circular emblem containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 0 1998 : 1

Ms. Mary Verstynen ·Clinical Research Manager Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K974136 Craniofacial Anchor Trade Name: Regulatory Class: II Product Codes: MBI, HWC, and GAN Dated: October 31, 1997 Received: November 3, 1997

Dear Ms. Verstynen:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A . . . . substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Mary Verstynen

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) NUMBER (IF KNOWN) : K974136 DEVICE NAME: Craniofacial Anchors

INDICATIONS FOR USE:

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The Craniofacial Anchors are indicated for use to assist resorbable suture in open and endoscopic brow lift procedures.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | 1979136 |

Prescription Use
(Per 21 CFR 801.109) X OR Over-The-Counter-Use
(Optional Format 1-2-96)