(86 days)
Perex Surgical, Inc.: MedPor Craniofacial Implants with Embedded Titanium Mesh, Porex Surgical, Inc.: MedPor Barrier Surgical Implant Biomaterials, Porex Medical: Medpor Surgical Implants, ePor Inc.: Porous HDPE Surgical Implants
Not Found
No
The device description and intended use focus on the material properties and physical form of the implant, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device is used for anatomical reconstruction and repair, which are structural and restorative functions, not therapeutic in nature.
No
Explanation: The device is an implant for anatomical reconstruction, not a tool for diagnosing medical conditions.
No
The device description clearly states it is made from physical materials (UHMWPE and titanium) and is an implant, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Device Description: The Synthes Porous Polyethylene implants are described as being made from materials like polyethylene and titanium and are intended for surgical implantation inside the body for reconstruction and repair.
- Intended Use: The intended use is for "non-load bearing applications in craniofacial reconstruction, cosmetic surgery, and repair of craniofacial trauma." This is a surgical application, not a diagnostic test performed on a sample.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
Synthes Porous Polyethylene implants are intended for use in non-load bearing applications in craniofacial reconstruction, cosmetic surgery, and repair of craniofacial trauma.
Product codes
GWO, FTM, FTL
Device Description
Synthes porous polyethylene implants are made from ultra-high molecular weight polyethylene (UHMWPE) or a combination of UHMWPE and titanium for use in anatomical reconstruction of the craniofacial skeleton. These implants are available, with and without embedded titanium, in porous and porous/smooth sheets of various shapes and dimensions. The interconnected, open pore structure of Synthes porous polyethylene implants allows for tissue ingrowth. Synthes porous polyethylene implants are intended for single-patient use only.
Synthes porous polyethylene implants are intended for use in non-load bearing applications in craniofacial reconstruction, cosmetic surgery, and repair of craniofacial trauma.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial skeleton
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Porex Surgical, Inc.: MedPor Craniofacial Implants with Embedded Titanium Mesh, Porex Surgical, Inc.: MedPor Barrier Surgical Implant Biomaterials, Porex Medical: Medpor Surgical Implants, ePor Inc.: Porous HDPE Surgical Implants
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo. There is a line underneath the word "SYNTHES". A registered trademark symbol is located to the right of the word.
OCT 5 - 2005
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA) | |
| 1302 Wrights Lane East | ||
| West Chester, PA 19380 | ||
| (610) 719-5000 | ||
| Device Name: | Synthes Porous Polyethylene Implants | |
| Classification: | Class II, § 882.5320 Preformed Alterable Cranioplasty Plate | |
| Predicate Device: | Porex Surgical, Inc.: MedPor Craniofacial Implants with Embedded | |
| Titanium Mesh | ||
| Porex Surgical, Inc.: MedPor Barrier Surgical Implant Biomaterials | ||
| Porex Medical: Medpor Surgical Implants | ||
| ePor Inc.: Porous HDPE Surgical Implants | ||
| Device Description: | Synthes porous polyethylene implants are made from ultra-high | |
| molecular weight polyethylene (UHMWPE) or a combination of | ||
| UHMWPE and titanium for use in anatomical reconstruction of the | ||
| craniofacial skeleton. These implants are available, with and | ||
| without embedded titanium, in porous and porous/smooth sheets of | ||
| various shapes and dimensions. The interconnected, open pore | ||
| structure of Synthes porous polyethylene implants allows for tissue | ||
| ingrowth. Synthes porous polyethylene implants are intended for | ||
| single-patient use only. |
Synthes porous polyethylene implants are intended for use in non-
load bearing applications in craniofacial reconstruction, cosmetic
surgery, and repair of craniofacial trauma. |
| | Substantial
Equivalence: | Documentation was provided which demonstrated the Synthes
Porous Polyethylene Implants are substantially equivalent to other
legally marketed devices.
The term "substantial equivalence" as used in this 510(k)
notification is limited to the definition of substantial equivalence
found in the Federal Food, Drug and Cosmetic Act, as amended and
as applied under 21CFR 807, Subpart E under which a device can
be marketed without premarket approval or reclassification. A
determination of substantial equivalency under this notification is
not intended to have any bearing whatsoever on the resolution of
patent infringement suits or any other patent matters. No
statements related to, or in support of substantial equivalence herein
shall be construed as an admission against interest under the US
Patent Laws or their application by the courts. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the agency's mission to promote health, well-being, and human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".
OCT 5 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kathy Anderson Regulatory Affairs Manager Synthes (USA) 1302 Wrights Lane East West Chester, PA 19380
Re: K051879
Trade/Device Name: Synthes Porous Polyethylene Implants Regulation Number: CFR 882.5320 Regulation Name: Preformed alterable cranioplasty plate Regulatory Class: II Product Code: GWO, FTM, FTL Dated: July 8, 2005 Received: July 11, 2005
Dear Ms. Anderson:
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 introtate 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, Dr to 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 devire can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, RDArou 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 not 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 100-1000.
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Page 2- Ms. Patricia Sandborn Beres
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 (240) 276-0210. 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,
Signature
Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A horizontal line runs underneath the word and logo. There is a period after the word "SYNTHES".
:
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| 2.0 | Indications for Use | Page | 1 | of | 1 | |
|---|---|---|---|---|---|---|
| 510(k) Number (if known): | K051879 | |||||
| Device Name: | Synthes (USA) Porous Polyethylene Implants | |||||
| Indications for Use: | Synthes Porous Polyethylene implants are intended for use in non-load bearing applications in craniofacial reconstruction, cosmetic surgery, and repair of craniofacial trauma. | |||||
| Prescription Use | X | AND/OR | Over-The-Counter Use | |||
| (Per 21 CFR 801.109) | (21 CFR 807 Subpart C) | |||||
| (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | ||||||
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||||||
| (Division Sign-Off) | ||||||
| Division of General, Restorative, | ||||||
| and Neurological Devices | ||||||
| 510(k) Number | K051879 |
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