LACTOSORB BONE PIN

K990291 · Biomet, Inc. · HTY · Mar 23, 1999 · Orthopedic

Device Facts

• Record ID: K990291
• Device Name: LACTOSORB BONE PIN
• Applicant: Biomet, Inc.
• Product Code: HTY · Orthopedic
• Decision Date: Mar 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LactoSorb® Bone Pin is indicated for use in the presence of appropriate immobilization in the following procedures: - 1. correction of hallux valgus (bunion) - 2. repair of metacarpal and phalangeal fusion and fractures

Device Story

LactoSorb® Bone Pin is a bioresorbable fixation device used in orthopedic surgery. Composed of synthetic PLLA/PGA copolymer derived from lactic and glycolic acids; device degrades in vivo via hydrolysis into metabolites. Intended for use by surgeons in clinical settings for bone fixation during hallux valgus correction or metacarpal/phalangeal fracture repair. Device provides mechanical stabilization to bone segments; strength is maintained during healing process. Benefits include elimination of need for secondary removal surgery due to bioresorbable nature.

Clinical Evidence

Bench testing only. In vitro mechanical comparative testing demonstrated adequate initial strength and superior strength retention (at least 80% at 8 weeks) compared to currently marketed resorbable pins.

Technological Characteristics

Bioresorbable synthetic polyester (PLLA/PGA copolymer). Degradation via hydrolysis. Form factor: bone pin.

Indications for Use

Indicated for patients requiring immobilization for hallux valgus (bunion) correction or repair of metacarpal and phalangeal fusion and fractures.

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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3/23/99

K996291

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## 510 (K) 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: | 87HTY |
| Device Name: | LactoSorb® Bone Pin |

The LactoSorb® Bone Pin is indicated for use in the presence of appropriate immobilization in the following procedures:

- 1. correction of hallux valgus (bunion)
- 2. repair of metacarpal and phalangeal fusion and fractures

The LactoSorb® Bone Pin is made of bioresorbable and biocompatible polymers that have been used in surgical procedures for numerous years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid (PLLA/PGA) copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids, which are then metabolized by the body.

The effectiveness of the LactoSorb® Bone Pin was determined by In VITRO mechanical comparative testing to currently marketed resorbable pins. The tests showed that the LactoSorb® pins demonstrated adequate initial strength and retained at least 80% of that strength at 8 weeks. In the same test environment at eight weeks, the comparative pins exhibited little or no strength.

In summary, the LactoSorb® Bone Pin is safe and effective for metacarpel and phalangeal repair. Mechanical testing demonstrated the Lactosorb® Bone Pin to be as effective or better than comparative resorbable bone pins.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 1994

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

Re: K990291 LactoSorb® Bone Pin Trade Name: Requlatory Class: II Product Codes: HTY and MAI Dated: January 22, 1999 Received: January 29, 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 controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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. ಗಿ 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 requlation 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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Page | | of of |

510 (k) NUMBER (IF KNOWN): K99029 /

DEVICE NAME: LactoSorb® Bone Pin

INDICATIONS FOR USE:

The LactoSorb® Bone Pin is indicated for use in the presence of appropriate immobilization in the following procedures:

- 1. correction of hallux valgus (bunion)
- 2. repair of metacar pal and phalangeal fusion and fractures

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ メ Use (Per 21 CFR 801.109)

OR

Over-The-Counter-

(Optional Format 1-2-96)

Tocòell

(Divisio eneral Restorative Devi 510(k) Numb

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