MACROPORE OS RECONSTRUCTION

K024169 · Macropore Biosurgery, Inc. · EZX · Jul 1, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K024169
• Device Name: MACROPORE OS RECONSTRUCTION
• Applicant: Macropore Biosurgery, Inc.
• Product Code: EZX · General, Plastic Surgery
• Decision Date: Jul 1, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MacroPore OS Reconstruction System is intended to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. The flat Protective Sheets with pore sizes up to 2.5mm are also indicated for cement restriction in total joint arthroplasty procedures. Only when used in conjunction with traditional rigid fixation, the MacroPore OS Reconstruction System is intended to maintain the relative position of weak bony tissue in trauma and reconstructive orthopedic procedures involving: - Long bones - Flat bones - Short bones - Irregular bones - Appendicular skeleton - Thorax When used alone (without traditional rigid fixation), the MacroPore OS Reconstruction System is intended to maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopedic procedures involving: - Tumor resections where bone strength has not been compromised - Iliac crest harvests - Ribs (excluding multiple segmental defects such as those found in flail chest) This device is not intended for use in the spine. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation.

Device Story

Resorbable graft containment system; composed of polylactic acid (PLA) porous/non-porous sheets, sleeves, screws, and tacks. Sheets/sleeves are malleable when heated to ~55°C, allowing 3D anatomical conformation; cut to size by surgeon. Used in orthopedic procedures to maintain position of bone grafts/fragments. Can be used alone or with traditional rigid fixation (plates/screws). Surgeon-operated in clinical/OR setting. Provides structural containment of bone graft materials; prevents dislocation of bone fragments. Benefits patient by stabilizing graft sites and facilitating bone reconstruction.

Clinical Evidence

Bench testing only. Aging studies confirmed rigidity and strength equivalent to predicate after 6 months. Mechanical testing verified tensile strength and rigidity. DSC testing confirmed amorphous, non-crystalline material state. Heating studies (60°C in saline) confirmed inherent viscosity stability over 120 minutes.

Technological Characteristics

Material: Polylactic acid (PLA). Form: Porous/non-porous sheets, sleeves, screws, tacks. Dimensions: Sheets 25x25mm to 160x200mm; sleeves 150mm length, 5-40mm diameter; screws 2.0-4.75mm diameter. Sensing/Actuation: None (mechanical). Energy: None. Sterilization: Not specified. Connectivity: None.

Indications for Use

Indicated for patients requiring maintenance of relative position of weak bony tissue, bone grafts, or bone graft substitutes in orthopedic trauma and reconstructive procedures (long, flat, short, irregular bones; appendicular skeleton; thorax). Also indicated for cement restriction in total joint arthroplasty. Contraindicated for use in the spine and for load-bearing applications unless used with traditional rigid fixation.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• MacroPore OS Protective Sheet
• Synthes Resorbable Meshes and Sheets

Submission Summary (Full Text)

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#### MacroPore OS Reconstruction System K024169 SUMMARY

# ADMINISTRATIVE INFORMATION

MacroPore Biosurgery, Inc. Manufacturer Name: 6740 Top Gun Street San Diego, CA 92121

> Kenneth K. Kleinhenz Director of Regulatory Affairs Telephone [phone] Fax [phone]

## DEVICE NAME

Classification Name: Trade/Proprietary Name: Plate, Fixation, Bone MacroPore OS Reconstruction System

# ESTABLISHMENT REGISTRATION NUMBER 2031733

# DEVICE CLASSIFICATION AND PRODUCT CODE

Official Contact:

As shown in 21CFR 888.3030 bone fixation appliances intended for use in orthopedic procedures are classified as Class II. They have been assigned Product Code HRS.

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#### INTENDED USE

The MacroPore OS Reconstruction System is intended to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. The flat Protective Sheets with pore sizes up to 2.5mm are also indicated for cement restriction in total joint arthroplasty procedures.

Only when used in conjunction with traditional rigid fixation, the MacroPore OS Reconstruction System is intended to maintain the relative position of weak bony tissue in trauma and reconstructive orthopedic procedures involving:

- Long bones
- Flat bones
- Short bones
- Irregular bones
- · Appendicular skeleton
- Thorax

When used alone (without traditional rigid fixation), the MacroPore OS Reconstruction System is intended to maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopedic procedures involving:

- · Tumor resections where bone strength has not been compromised
- Iliac crest harvests
- Ribs (excluding multiple segmental defects such as those found in flail chest)

This device is not intended for use in the spine. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation.

#### Design Characteristics

MacroPore OS Reconstruction System is a resorbable graft containment system composed of various sized porous sheet and sleeves, non-porous sheets and associated fixation screws and tacks manufactured from polylactic acid (PLA). The MacroPore OS Reconstruction System is composed of MacroPore OS Reconstruction System Protective Sheets, MacroPore OS Reconstruction System Protective Sleeves, and MacroPore OS Reconstruction Screws and Tacks.

The MacroPore OS Reconstruction System Protective Sheets and Protective Sleeves can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or shape the MacroPore OS Reconstruction System to the desired shape or size. MacroPore OS Reconstruction System Protective Sheets and Protective Sleeves are fully malleable when heated to approximately 55℃ (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation.

The MacroPore OS Reconstruction System Protective Sheets can be rolled into a tube or used as a flat sheet. The MacroPore OS Reconstruction System Protective Sheets and Protective Sleeves can be used either alone or in conjunction with internal bone fixation devices such as plates and screws, which also can serve to fixate the MacroPore OS Reconstruction System and prevent dislocation.

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#### K024169 SUMMARY ______________________________________________________________________________________________________________________________________________________________ MacroPore OS Reconstruction System

The MacroPore OS Reconstruction System Tacks range in size from 1.7mm to 2.2mm in diameter with lengths from 3.6mm to 5.6mm and the MacroPore OS Reconstruction System Screws range in size from 2.0mm to 4.75mm in diameter with lengths from 3.35mm to 30mm. The MacroPore OS Reconstruction System Protective Sheet is provided in sheets of 25 x 25 mm to 160 x 200 mm. The MacroPore OS Reconstruction System Protective Sleeves are provided in lengths of 150mm to 5mm with inner diameters that range from 5mm up to 40mm. The MacroPore Reconstruction System Protective Sleeves are provided in circular, square, trapezoidal, and parabolic shapes. The MacroPore OS Reconstruction System Protective Sleeves are provided with and without serrated edges and / or tapered end(s) for ease of surgical installation. The MacroPore OS Reconstruction System Protective Sheets and Protective Sleeves are provided with and without macroporous holes. The pore size ranges from 1.7mm to 4.0mm in diameter, with pores distributed randomly or uniformly throughout the sheet/sleeve in an offset or aligned pattern. The thickness of the MacroPore OS Reconstruction System Protective Sheets ranges from 0.5mm to 5.0mm according to the orthopedic region to be treated. The thickness of the MacroPore OS Reconstruction System Protective Sleeves ranges from 0.8mm to 5.0mm according to the orthopedic region to be treated.

### Material Composition

The MacroPore OS Reconstruction System is fabricated from polylactic acid (PLA).

### In Vitro Testing

Because the MacroPore OS Reconstruction System Protective Sheet is intended to be heated in the surgical suite to temperatures above the material's glass transition temperature to facilitate shaping to anatomic structures, testing was performed to determine the effect of prolonged heating in saline at 60℃ on inherent viscosity. The testing demonstrates that viscosity stayed within an appropriate range over 120 minutes. Therefore, the relatively brief exposure anticipated during the surgical preparation of MacroPore OS Protective Sheet is not expected to have a significant effect on its mechanical properties.

Aging studies were performed on MacroPore OS Reconstruction System components. Testing demonstrated that the MacroPore OS Reconstruction System Protective Sheet is as rigid and as strong as the predicate after 6 months of exposure. Mechanical testing was performed on the MacroPore OS Reconstruction System Protective Sheets and MacroPore OS Reconstruction System Screws. Testing determined the MacroPore OS Reconstruction System to be substantially equivalent to the mechanical strengths of the predicate devices under indication for use conditions.

Crystallinity was tested for by DSC (differential scanning calorimetery). This test measures the amount of heat energy that is absorbed by a material. A crystalline material will require more energy once it reaches it's melting point. This release of heat energy can be seen on a graph as a sharp spike and is referred to as a "melting endotherm". The tests ran on the sterile and nonsterile samples revealed no endothermic spikes, indicating that the implants are amorphous and non-crystalline.

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## EQUIVALENCE TO MARKETED PRODUCT

The MacroPore OS Reconstruction System shares materials, indications, and design principles with the following predicate devices which have been determined by FDA to be substantially equivalent to pre-amendment devices: MacroPore OS Protective Sheet and Synthes Resorbable Meshes and Sheets.

#### Indications For Use

The MacroPore OS Reconstruction System shares substantially equivalent indications for use with the predicate devices.

#### Design and Materials

The design and materials of MacroPore OS Reconstruction System and the predicate devices (MacroPore OS and Synthes Resorbable Sheet) are nearly identical as they all are made from resorbable polylactide (PLA) material and are provided in sheets and have fixation screws and tacks of similar shapes and sizes. Both the predicate device and the MacroPore OS Reconstruction System Sheet have a semi-rigid construction with pores of similar diameter and The pore size and spacing of the predicate device is within the pore size and spacing spacing. specifications of the MacroPore OS Reconstruction System Protective Sheets. The dimensions of the predicate device are also comparable to the MacroPore OS Reconstruction System sheet as both devices are provided in rectangular sheets that are several centimeters in size. The mechanical characteristics of the MacroPore OS Reconstruction System are substantially equivalent to the predicate device with respect to tensile strength, and rigidity as measured by the materials spring constant. In addition to physical characteristics, both the predicate device and the MacroPore OS Reconstruction System Sheets can be shaped with warm water and cut to specific shapes and sizes by the end user.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2003 JUL 1

Mr. Kenneth K. Kleinhenz Director of Regulatory Affairs MacroPore Biosurgery, Inc. 6740 Top Gun Street San Diego, California 92121

Re: K024169

Trade/Device Name: MacroPore OS Reconstruction System Regulation Number: 21 CFR 878.3300, 888.3030, 888.3040 Regulation Name: Surgical mesh, Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Regulatory Class: II

Product Code: EZX, HRS, HWC, and MAI Dated: April 4, 2003 Received: April 7, 2003

Dear Mr. Kleinhenz:

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

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Page 2 - Mr. Kenneth K. Kleinhenz

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. 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" (21CFR Part 807.97). 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 [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark N. Wilkerson

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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# Device Name: MacroPore OS Reconstruction System

# Indications for Use:

The MacroPore OS Reconstruction System is intended to maintain the relative position of weak bony tissue such as bone graft substitutes, or bone fragments from comminuted fractures. The flat Protective Sheets with pore sizes up to 2.5mm are also indicated for cement restriction in total joint arthroplasty procedures.

Only when used in conjunction with traditional rigid fixation, the MacroPore OS Reconstruction System is intended to maintain the relative position of weak bony tissue in trauma and reconstructive orthopedic procedures involving:

- · Long bones
- Flat bones
- Short bones
- · Irregular bones
- · Appendicular skeleton
- Thorax

When used alone (without traditional rigid fixation), the MacroPore OS Reconstruction System is intended to maintain the relative position of bone graft substitutes in reconstructive orthopedic procedures involving:

- · Tumor resections where bone strength has not been compromised
- · Iliac crest harvests
- · Ribs (excluding multiple segmental defects such as those found in flail chest)

This device is not intended for use in the spine. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use***_***_

Over-The-Counter Use - - -

510(k) Number