LACTOSORB HAND SYSTEM

K991763 · Biomet, Inc. · HRS · Jul 30, 1999 · Orthopedic

Device Facts

• Record ID: K991763
• Device Name: LACTOSORB HAND SYSTEM
• Applicant: Biomet, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Jul 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LactoSorb® Hand System is indicated for use in closed noncomminuted diaphyseal metacarpal fractures in the presence of appropriate immobilization.

Device Story

LactoSorb® Hand System consists of bioresorbable plates and screws for fixation of closed noncomminuted diaphyseal metacarpal fractures. Material is synthetic polyester copolymer derived from lactic and glycolic acids (PLLA/PGA). Device provides mechanical fixation similar to metal systems; degrades in vivo via hydrolysis into lactic and glycolic acids, which are metabolized by the body. Complete resorption occurs by 12 months, eliminating need for secondary removal surgery. Used by surgeons in clinical settings.

Clinical Evidence

Bench testing only. Effectiveness determined by mechanical testing comparing the system to metal fixation devices and the LactoSorb® Bone Pin.

Technological Characteristics

Bioresorbable PLLA/PGA copolymer (synthetic polyester). Plates and screws. Resorption via hydrolysis. Biocompatible.

Indications for Use

Indicated for surgical fixation of closed noncomminuted diaphyseal metacarpal fractures in patients requiring immobilization.

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.

Reference Devices

• LactoSorb® Bone Pin

Submission Summary (Full Text)

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K991763

## Summary of Safety and Effectiveness

| Submitter: | Biomet, Inc.<br>P.O. Box 587<br>Airport Industrial Park<br>Warsaw, Indiana 46581-0587 |
|-----------------|---------------------------------------------------------------------------------------|
| Contact Person: | Michelle L. McKinley |
| Product Code: | 87 HRS (Plate)<br>87 HWC (Screw) |
| Device Name: | LactoSorb® Hand System |

The LactoSorb® Hand System is indicated for use in closed noncomminuted diaphyseal metacarpal fractures in the presence of appropriate immobilization.

The LactoSorb® plates and screws are made of bioresorbable and biocompatible polymer that have been used in surgical procedures for a number of years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic (PLLA/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 PLLA/PGA material has been well documented since the early 1970s when the FDA first approved the use of resorbable PLLA/PGA sutures. The LactoSorb® material has been found to be biocompatible in both soft and hard bone tissues.

The effectiveness of this resorbable system was determined by mechanical testing. This system is as effective as similar metal fixation systems on the market as well as the LactoSorb® Bone Pin. The devices completely resorb by 12 months IN VIVO eliminating the need for long-term removal.

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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with three lines representing its wings and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 30 1999

Ms. Michelle L. McKinley Regulatory Specialist Biomet Incorporated P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K991763 Trade Name: LactoSorb® Hand System Regulatory Class: II Product Code: HRS, HWC, MAI Dated: May 6, 1999 Received: May 24, 1999

Dear Ms. McKinley:

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.

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Page 2 – Ms. Michelle L. McKinley

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.gov/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): K991763____________________________________________________________________________________________________________________________________________

DEVICE NAME: LactoSorb® Hand System

INDICATIONS FOR USE:

The LactoSorb® Hand System is indicated for surgical fixation of closed
of the success is indicated for any of finatures in the presence of The LactoSorb® Hand System is marcared of the presence of appropriate immobilization.

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Prescription Use | X | OR | Over-The-Counter |
|--------------------------|---|----|--------------------------|
| Use (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |

(Division Sign-Off)

Division of General Restorative Devices

K(k) Number K991763