BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER

K071577 · Biomet Microfixation, Inc. · HRS · Sep 6, 2007 · Orthopedic

Device Facts

• Record ID: K071577
• Device Name: BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER
• Applicant: Biomet Microfixation, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Sep 6, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Biomet Microfixation LactoSorb® Pectus Stabilizer is intended to be used with Lorenz Pectus Support Bars cleared via K972420 and K061384 for repairing Pectus Excavatum and other sternal deformities when additional stabilization is necessary.

Device Story

LactoSorb® Pectus Stabilizer is a resorbable implant designed to secure Pectus Support Bars to the chest wall during surgical repair of Pectus Excavatum and other sternal deformities. The device acts as a fixation accessory for the Pectus Support Bar, which is used to reposition the sternum by applying outward force. The stabilizer is made of a resorbable copolymer (polyester derivative of lactic and glycolic acids) and does not require removal. It is intended for use by surgeons in a clinical/surgical setting. By providing additional stabilization, the device assists in maintaining the position of the support bar, potentially improving the correction of the chest wall deformity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Resorbable copolymer (polyester derivative of lactic and glycolic acids). Mechanical bone fixation appliance/accessory. Class II device. No software or electronic components.

Indications for Use

Indicated for patients requiring repair of Pectus Excavatum or other sternal deformities where additional stabilization of the Pectus Support Bar to the chest wall is necessary.

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.

Predicate Devices

• Lorenz Pectus Stabilizer (K981789)
• Lorenz Pectus Support Bar (K972420)
• Lorenz Pectus Support Bar System (K061384)

Submission Summary (Full Text)

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K071577 page 14

Image /page/0/Picture/1 description: The image shows the logo for Microfixation, Inc. The logo consists of the word "BIOMET" in a bold, sans-serif font, with the letters slightly overlapping. Below the word "BIOMET" is the text "MICROFIXATION, INC." in a smaller, sans-serif font.

1520 Tradeport Drive Jacksonville, FL 32218 904-741-4400 fax [phone] Kim Reed, Requlatory Affairs Manager

## 510(k) Summarv

SEP - 6 2007

Trade Name: Biomet Microfixation LactoSorb® Pectus Stabilizer

Classification and Common Name and Reference: Bone Plate CFR 21 888.3030

Product Code: HRS

Device Classification: Class II

Device Description: The LactoSorb® Pectus Stabilizer provides the surgeon with a means to secure the Pectus Support Bar to the chest wall. The Biomet Microfixation Pectus Bar is used to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shaped deformity. The LactoSorb® Pectus Stabilizer is a resorbable implant and does not require removal.

Intended Use: The Biomet Microfixation LactoSorb® Pectus Stabilizer is intended to be used with Lorenz Pectus Support Bars cleared via K972420 and K061384 for repairing Pectus Excavatum and other sternal deformities when additional stabilization is necessary.

Materials Lactosorb® (resorbable copolymer) - a polyester derivative of lactic and glycolic acids

## Possible Adverse Effects:

- 1. Infection can lead to failure of the procedure.
- 2. Neurovascular injuries can occur due to surgical trauma.
- 3. Bending, fracture, loosening, rubbing and migration of the devices can occur as a result of excessive activity, trauma or load bearing.
- 4. Implantation of foreign materials can result in an inflammatory response or allergic reaction.
- 5. Sensitivity reactions or allergic reaction to the implant material.
- 6. Pain, discomfort, or abnormal sensation due to the presence of the device.
- 7. Surgical trauma; permanent or temporary nerve damage, permanent or temporary damage to heart, lungs, and other organs, body structures or tissues.
- 8. Skin irritation, infection, and pneumothorax.
- 9. Fracture, breakage, migration, or loosening of the implant.
- 10. Permanent injury or death.

Apart from these adverse effects there are always possible complications of any surgical procedure such as, but not limited to, infection, nerve damage, and pain, which may not be related to the implant.

Substantial Equivalence: The Biomet Microfixation LactoSorb® Pectus Stabilizer is believed to be substantially equivalent in application and function to the Lorenz Pectus Stabilizer K981789, Lorenz Pectus Support Bar K972420 and Lorenz Pectus Support Bar System K061384.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Microfixation, Inc. % Ms. Kim Reed Regulatory Affairs Manager 1520 Tradeport Drive Jacksonville, FL 32218-2480

SEP = 6 2007

Re: K071577

Trade/Device Name: Biomet Microfixation LactoSorb® Pectus Stabilizer Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: August 10, 2007 Received: August 13, 2007

Dear Ms. Reed:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Kim Reed

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or 240-276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sincerely yours,

Barbara Buehrn

for

Mark N. Miller

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K071577 page 71

## Indications for Use

510(k) Number (if known):

Device Name: Biomet Microfixation LactoSorb® Pectus Stabilizer

Indications For Use:

The Biomet Microfixation LactoSorb® Pectus Stabilizer is intended to be used with Lorenz Pectus Support Bars cleared via K972420 and K061384 for repairing Pectus Excavatum and other sternal deformities when additional stabilization is necessary.

× Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

No Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Seubare Bucher.

Division of General, Restorative. aud Neurological Devices

t's,

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510(k) Number K071577