(50 days)
Not Found
No
The device description focuses on the material composition, physical properties, and mechanical aspects of a resorbable bone fixation system. There is no mention of software, algorithms, data processing, or any terms related to AI or ML. The performance studies are based on in vitro mechanical testing, not algorithmic performance.
Yes
This device is a bone fixation system used to treat trauma and reconstructive procedures of the midface or craniofacial skeleton, which indicates a therapeutic purpose.
No
The device is a resorbable bone fixation system used for trauma and reconstructive procedures, not for diagnosing conditions.
No
The device description clearly outlines physical components such as porous and non-porous sheets, fixation tacks and screws, and associated manual instruments, all made from poly lactic acid. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use and indications clearly describe a device used for surgical fixation and reconstruction of bone fractures and deformities in the midface and craniofacial skeleton. This is a surgical implant/device, not a diagnostic test performed on samples outside the body.
- Device Description: The device description details a system of resorbable plates, sheets, screws, and tacks made from poly lactic acid, along with associated surgical instruments. This is consistent with a surgical implant/device used for bone fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The device is directly implanted into the patient for structural support and fixation.
Therefore, this device falls under the category of a surgical implant/device and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
A. General Indications: Trauma procedures of the midface or craniofacial skeleton.
Specific Indications:
1). Comminuted fractures of the naso-ethmoidal infraorbital areas.
2). Comminuted fractures of the frontal sinus wall:
- 3). Pediatric midface or craniofacial trauma
4). Lefort (I, II, III) fractures. ·
5). Orbital floor fractures.
6).Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones. 7). Trauma of the craniofacial skeleton including: frontal, temporal , sphenoid, and occipital bones.
B. General Indications: Reconstructive procedures of the midface or craniofacial skeleton..
Specific Indications:
1). Infant craniofacial surgery (i.e., craniosynostosis, congentital malformations, trauma, etc.).
- 2). Lefort (I, II, III) osteotomies.
- 3). Tumor reconstruction in midface or craniofacial procedures.
- 4). Bone graft procedures in the midface or craniofacial skeleton.
- 5). Pediatric reconstructive procedures.
- 6). Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones.
- 7). Craniotomy flap fixation.
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
MacroPore FX, PS, NS, LP is a resorbable bone fixation system composed of various sized porous sheets, non-porous sheets, and associated fixation tacks and screws manufactured from poly lactic acid. The MacroPore FX, PS, NS, LP are composed of MacroPore FX, PS, NS, LP Protective Sheets and MacroPore FX and LP Screws and Tacks. MacroPore Protective Sheets 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 Plates and Protective Sheets to the desired shape or size.
The MacroPore Plate and Protective Sheets are fully malleable when heated to approximately 55 degrees C (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPore FX, PS, NS, LP bone fixation system includes a selection of resorbable screws, tacks, and associated manual instruments. Tacks range in size from 1.5mm to 2.0mm in outer diameter. Screws range in size from 2.0mm in outer diameter. The MacroPore Plates and Protective Sheets come in various sizes ranging from 0.5mm in thickness according to the region to be treated. The MacroPore Protective Sheets range in size from as small as 20mm x 20mm to as large as 120mm x 120mm. The MacroPore Protective Sheet is provided with and without macroporous holes. The macroporous holes range in size from 500 microns to 3,000 microns in diameter. All configurations are to be within a mass of 18 grams of polymer.
Various manual instruments (PowerTack Driver, StarBurst Screw drivers, Tack Pusher, taps, drill bit, etc.) are used in conjunction with the MacroPore FX, PS, NS, LP bone fixation system to assist in the installation process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Midface, craniofacial skeleton (naso-ethmoidal infraorbital areas, frontal sinus wall, orbital floor, maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, lacrimal bones, frontal, temporal, sphenoid, and occipital bones)
Indicated Patient Age Range
Infant, Pediatric
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)
Mechanical testing of the MacroPore FX, PS, NS, LP System demonstrates that the device is substantially equivalent to the predicate. Test results indicate that the mechanical properties of the MacroPore FX, PS, NS, LP are substantially equivalent to the mechanical properties of the predicate devices: MacroPore PX Pediatric System and MacroPore Protego System (plates, and screws) under indication for use conditions.
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.
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
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
SEP 1 8 2001
ADMINISTRATIVE INFORMATION
Manufacturer Name:
Official Contact:
MacroPore, Inc. 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, Bone
MacroPore FX, PS, NS, LP
ESTABLISHMENT REGISTRATION NUMBER
2031733
DEVICE CLASSIFICATION AND PRODUCT CODE
As shown in 21CFR 872.4760 - Bone Plates are intended to stabilize fractured bone structures in the oral cavity and are classified as Class II. Bone Plates have been assigned Product Code JEY.
1
INTENDED USE
A. General Indications: Trauma procedures of the midface or craniofacial skeleton.
Specific Indications:
1). Comminuted fractures of the naso-ethmoidal infraorbital areas.
2). Comminuted fractures of the frontal sinus wall:
- 3). Pediatric midface or craniofacial trauma
4). Lefort (I, II, III) fractures. ·
5). Orbital floor fractures.
6).Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones. 7). Trauma of the craniofacial skeleton including: frontal, temporal , sphenoid, and occipital bones.
B. General Indications: Reconstructive procedures of the midface or craniofacial skeleton.. Specific Indications:
1). Infant craniofacial surgery (i.e., craniosynostosis, congentital malformations, trauma, etc.).
- 2). Lefort (I, II, III) osteotomies.
- 3). Tumor reconstruction in midface or craniofacial procedures.
- 4). Bone graft procedures in the midface or craniofacial skeleton.
- 5). Pediatric reconstructive procedures.
- 6). Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones.
- 7). Craniotomy flap fixation.
DEVICE DESCRIPTION
Design Characteristics
MacroPore FX, PS, NS, LP is a resorbable bone fixation system composed of various sized porous sheets, non-porous sheets, and associated fixation tacks and screws manufactured from poly lactic acid. The MacroPore FX, PS, NS, LP are composed of MacroPore FX, PS, NS, LP Protective Sheets and MacroPore FX and LP Screws and Tacks. MacroPore Protective Sheets 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 Plates and Protective Sheets to the desired shape or size.
The MacroPore Plate and Protective Sheets are fully malleable when heated to approximately 55°C (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPore FX, PS, NS, LP bone fixation system includes a selection of resorbable screws, tacks, and associated manual instruments. Tacks range in size from 1.5mm to 2.0mm in outer diameter. Screws range in size from 2.0mm in outer diameter. The MacroPore Plates and Protective Sheets come in various sizes ranging from 0.5mm in thickness according to the region to be treated. The MacroPore Protective Sheets range in size from as small as 20mm x 20mm to as large as 120mm x 120mm. The MacroPore Protective Sheet is provided with and without macroporous holes. The macroporous holes range in size from 500 microns to 3,000 microns in diameter. All configurations are to be within a mass of 18 grams of polymer.
Various manual instruments (PowerTack Driver, StarBurst Screw drivers, Tack Pusher, taps, drill bit, etc.) are used in conjunction with the MacroPore FX, PS, NS, LP bone fixation system to assist in the installation process.
2
Material Composition
The MacroPore FX, PS, NS, LP are fabricated from polylactic acid (PLA).
In Vitro Testing
Mechanical testing of the MacroPore FX, PS, NS, LP System demonstrates that the device is substantially equivalent to the predicate. Test results indicate that the mechanical properties of the MacroPore FX, PS, NS, LP are substantially equivalent to the mechanical properties of the predicate devices: MacroPore PX Pediatric System and MacroPore Protego System (plates, and screws) under indication for use conditions.
EQUIVALENCE TO MARKETED PRODUCT
The MacroPore FX, PS, NS, LP shares indications and design principles with the following predicate devices which have been determined by FDA to be substantially equivalent to pre-amendment devices: MacroPore PX Pediatric System and the MacroPore Protective Sheet (Protego System) Class II medical devices that were cleared for marketing in the United States under K002207, K972913 respectively.
Indications For Use
The MacroPore FX, PS, NS, LP and the predicate devices share identical indications for use with the MacroPore PX Pediatric System predicate. Additionally, the MacroPore FX, PS, NS, LP devices have substantially equivalent indications for use with the MacroPore Protego Ssytem as they are both indicated for the trauma and reconstructive procedures in the midface and craniofacial skeleton.
Design and Materials
Both the MacroPore FX. PS. NS. LP and the predicate devices are manufactured from bioabsorbable materials under substantially equivalent conditions. The physical designs of MacroPore FX, PS, LP and the predicate devices are substantially equivalent, consisting of a plates, screws, tacks, and protective sheets. The mechanical characteristics of the MacroPore FX, PS, NS, LP and the predicate devices are substantially equivalent to the predicate device under indications for use conditions. The material used in the MacroPore FX, PS, NS, LP is also substantially equivalent to the predicate devices as they are resorbable polylactide and polyglycolide polymers. In addition to physical characteristics, both the predicate device and the MacroPore FX, PS, NS, LP can be cut and molded to specific shapes and sizes by the end user.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Public Health Service
SEP 1 8 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kenneth K. Kleinheinz Director of Regulatory Affairs MacroPore, Incorporated 6740 Top Gun Street San Diego, California 92121
Re: K012413
Trade/Device Name: MacroPore FX, PS, NS, LP Regulation Number: 872.4760 Regulation Name: Plate Bone Regulatory Class: II Product Code: JEY Dated: July 27, 2001 Received: July 30, 2001
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
4
Page 2 - Mr. Kleinhenz
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ederal states and registered to the limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice alla listing (21 CF R Furt 067), assetses (QS) regulation (21 CFR Part 820); and if requirents as sectorin in allo qualify adiation control provisions (section 531-542 of the Act; 21): CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your 510(k) This letter will anow you to begal finding of substantial equivalence of your device to a premarket notification. The PDF 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 If you desire specific as for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and Compliance at (301) 59 - e, please contact the Office of Compliance at (301) 594-4639. advertibing or your the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the notification (210) 10 00197) - 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,
L. Clatrand
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Device Name: MacroPore FX, PS, NS, LP
Indications for Use:
A. General Indications: Trauma procedures of the midface or craniofacial skeleton. Specific Indications:
1). Comminuted fractures of the naso-ethmoidal infraorbital areas.
2). Comminuted fractures of the frontal sinus wall.
3). Pediatric midface or craniofacial trauma
4). Lefort (I, II, III) fractures.
5). Orbital floor fractures.
5). Oronal noor fractares. 7). Trauma of the craniofacial skeleton including: frontal, parietal, temporal , sphenoid, and occipital bones.
B. General Indications: Reconstructive procedures of the midface or craniofacial skeleton.. Specific Indications:
1). Infant craniofacial surgery (i.e., craniosynostosis, congentital malformations, trauma, etc.).
- 2). Lefort (I, II, III) osteotomies.
3). Tumor reconstruction in midface or craniofacial procedures.
4). Bone graft procedures in the midface or craniofacial skeleton.
- 5). Pediatric reconstructive procedures.
- 6). Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones.
- 7). Craniotomy flap fixation.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Susan Pump OR
Over-The-Counter Use
(Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number _