LACTOSORB PANELS AND FASTENERS

K984390 · Biomet, Inc. · HRS · Aug 7, 2000 · Orthopedic

Device Facts

• Record ID: K984390
• Device Name: LACTOSORB PANELS AND FASTENERS
• Applicant: Biomet, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Aug 7, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LactoSorb® Panels and Fasteners are used in maintaining the position of bony fragments or morselized bone graft in Iliac Crest autograft procedures. This product is not intended for use in the spine or joint space. This product is also not indicated for pelvic fracture fixation.

Device Story

LactoSorb® Panels and Fasteners are bioresorbable surgical implants designed to stabilize bone fragments or bone graft material during Iliac Crest autograft procedures. The device is composed of a synthetic polyester copolymer derived from lactic and glycolic acids. Following implantation, the material undergoes in vivo hydrolysis, breaking down into lactic and glycolic acids which are subsequently metabolized by the body. The device provides mechanical fixation for bone segments, facilitating healing in reconstructive surgical contexts. It is intended for use by surgeons in clinical settings. The device is not for use in spinal, joint, or pelvic applications.

Clinical Evidence

No clinical data provided. Safety and biocompatibility were established based on studies of the material in trauma and reconstructive procedures in the midface and craniofacial skeleton.

Technological Characteristics

Bioresorbable synthetic polyester copolymer (polylactic/polyglycolic acid). Material degrades via hydrolysis in vivo. Form factor includes panels and fasteners for bone fixation.

Indications for Use

Indicated for maintaining position of bony fragments or morselized bone graft during Iliac Crest autograft procedures. Contraindicated for use in spine, joint space, or pelvic fracture fixation.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Submission Summary (Full Text)

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## AUG 7 2000

# K984390

# 510 (k) Summary of Safety and Effectiveness

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

Tracy J. Bickel Contact Person:

Product Code: 87HRS, 87HRS, 87HWC

Device Name: LactoSorb® Panels and Fasteners

The LactoSorb® Panels and Fasteners are used in maintaining the position of bony of bony fragments or morselized bone graft in Iliac Crest autograft procedures. This product is not intended for use in the spine or joint space. This product is also not indicated for pelvic fracture fixation.

The LactoSorb® devices are made of bioresorbable and Ine backed activers that have been used in surgical procedures Brocompacible porymers chac have copolymer is synthetic polyester derived from lactic and glycolic acids. polylactic/polyglycolic acid copolymer degrades and resorbs IN vivo by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found meconocible by the both soft tissue and bone tissue. Both co be brocomputible in lostudies have proven the safety and preciliadar and these devices in trauma and reconstructive procedures in the midface and craniofacial skeleton.

These devices provide equivalent fixation as predicate devices cleared for use in oral-maxillo-craniofacial reconstructive procedures as well as pelvic reconstruction.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### 7 2000 AUG

Ms. Tracy J. Bickel Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K984390

Trade Name: Biomet LactoSorb® Panels and Fasteners Regulatory Class: II Product Code: HRS, HWC, and MAI Dated: May 8, 2000 Received: May 9, 2000

Dear Ms. Bickel:

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 control provisions of the Act. The general control 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 Regulations, 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 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 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.

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.

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### Page 2 - Ms. Tracy J. Bickel

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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Dune R. Lochner

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 510(K) NUMBER IF KNOWN: __ K984390

DEVICE NAME: LactoSorb® Panels and Fasteners

## INDICATIONS FOR USE:

The LactoSorb® Panels and Fasteners are used in maintaining the position of bony The Lactosoft @ I alles and I assession Iliac crest autograft procedures. This product is not intended for use in the spine or joint space. This product is not intended for pelvic fracture fixation.

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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)

Dwna R. Lochner.

(Division Sign-Off) Division of General Restorative Devices 510/2) Number K984390