2.5 MM LACTOSORB SCREWS

K981666 · Biomet, Inc. · DZL · Nov 3, 1998 · Dental

Device Facts

• Record ID: K981666
• Device Name: 2.5 MM LACTOSORB SCREWS
• Applicant: Biomet, Inc.
• Product Code: DZL · Dental
• Decision Date: Nov 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 2.5 mm LactoSorb® Screws are indicated for use as fixation in mandibular osteotomy procedures, including but not limited to: 1. sagittal split osteotomy 2. vertical ramus osteotomy 3. inferior border osteotomy 4. subapical osteotomy 5. genioplasty

Device Story

2.5 mm LactoSorb® Screws are bioresorbable fixation devices for mandibular osteotomy procedures. Composed of synthetic polylactic/polyglycolic acid copolymer; material degrades in vivo via hydrolysis into lactic and glycolic acids, which are metabolized by the body. Screws maintain mechanical strength for 6-8 weeks post-implantation and undergo complete resorption in approximately one year. Used by surgeons in clinical settings for craniomaxillofacial skeletal reconstruction and trauma. Efficacy established through biomechanical testing and clinical history of similar resorbable devices.

Clinical Evidence

Efficacy demonstrated via biomechanical testing and clinical use. Biocompatibility confirmed in animal studies for both soft and bone tissue. No specific clinical trial metrics (e.g., p-values, sensitivity) provided.

Technological Characteristics

Bioresorbable synthetic polyester (polylactic/polyglycolic acid copolymer). Mechanical fixation device. Strength retention: 6-8 weeks. Resorption time: ~1 year. Biocompatible.

Indications for Use

Indicated for fixation in mandibular osteotomy procedures, including sagittal split, vertical ramus, inferior border, subapical osteotomy, and genioplasty.

Regulatory Classification

Identification

An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.

Submission Summary (Full Text)

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## 3 1998 NOV

## 510 (k) Summary of Safety and Effectiveness

K981666

Biomet, Inc. Submitter: P.(). Box 587 Ai::port Industrial Park Warsaw, IN 46581-0587

Contact Person: Mary L. Verstynen

Product Code: JEY

2.5 mm LactoSorb® Screws Device Name:

The 2.5 mm LactoSorb® Screws are indicated for use as fixation in mandibular osteotomy procedures, including but not limited to:

::

:

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- sagittal split osteotomy 1.
- 2. vertical ramus osteotomy
- inferior border osteotomy 3 .
- subapical osteotomy বাংলাদেশে
- genioplasty 5.

The 2.5 mm LactoSorb® Screws are composed 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/pclyglycolic acid copolymer degrades and resorbs IN vIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body. In animal studies LactoSorb® has been found to be biocompatible in both soft tissue and bone tissue. Lact:oSorb® devices have been marketed for over two years for use in trauma and reconstructive procedures in the craniomaxillofacial skeleton and have been found to be both safe and effective.

The efficacy of the 2.5 mm LactoSorb® Screws have been demonstrated by biomechanical testing and clinical use. The screws maintain their strength for at least 6-8 weeks and completely resorb in approximately one year.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human figures. The figures are connected and appear to be moving forward.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 1998

Ms. Mary L. vertstynen Biomet, Incorporated Airport Industrial Park Warsaw, Indiana 46581-0587

Re: K981666 Trade Name: 2.5 mm LactoSorb® Screws Requlatory Class: II Product Code: DZL Dated: August 5, 1998 Received: August 6, 1998

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 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). You may, therefore, market the device, subject to the qeneral 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 requlations 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 requirements, as set forth in the Quality System Regulation (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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Verstynen

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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" (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.gov/cdrh/dsma/dsmamajn.html".

Sincerely yours,

Timothy A. Ulatowski

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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of

510 (k) NUMBER (IF KNOWN) : __________________________________________________________________________________________________________________________________________________

2.5mm LactoSorb Screw__ DEVICE NAME:

## INDICATIONS FOR USE:

The 2.5mm IactoSorb Screws are indicated for use as fixation
The 2.5mm Iactores are associence, including but not limited The 2.5mm Iacto5orb Screws are Indicated 10. about 10.000
in mandibular osteotomy procedures, including but not limited to:

- 1. sagittal split osteotomy
- 2. vert:cal ramus osteotomy
- 3. infecior border osteotomy
- 4. subapical osteotomy
- 5. genioplasty

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescript:.on Use
(Per 21 CFR 801.109)

. ...

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

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(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. K981666

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