(195 days)
Not Found
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a resorbable graft containment system. There is no mention of AI, ML, image processing, or any computational analysis of data.
Yes
The device is described as a "reconstructive system" intended to maintain the relative position of weak bony tissue, bone grafts, or bone fragments, which indicates it provides a therapeutic benefit by aiding in the healing and stabilization of bone structures.
No
The device is a resorbable graft containment system used to maintain the relative position of weak bony tissue, bone grafts, or bone graft substitutes. It is a surgical implant designed for reconstructive orthopedic procedures, not for diagnosis.
No
The device description clearly outlines physical components made of polylactic acid (PLA), including sheets, sleeves, screws, and tacks. There is no mention of software as a component of the device itself.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a device used in vivo (within the body) to maintain the position of bony tissue and bone grafts during surgical procedures. This is a surgical implant, not a diagnostic test performed on samples outside the body.
- Device Description: The description details physical components like sheets, sleeves, screws, and tacks made of polylactic acid (PLA), designed to be implanted. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
The device is a surgical implant used for orthopedic reconstruction.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
HRS, EZX, HWC, MAI
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bones, Flat bones, Short bones, Irregular bones, Appendicular skeleton, Thorax, Iliac crest, Ribs. Device is not intended for use in the spine.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.3300 Surgical mesh.
(a)
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.(b)
Classification. Class II.
0
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 (858) 458-0900 Fax (858) 458-0994
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.
1
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.
2
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.
Page 3 of 4
3
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.
4
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
5
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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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
6
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use__
Over-The-Counter Use - - -
510(k) Number