SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS

K051879 · Synthes (Usa) · FTM · Oct 5, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051879
• Device Name: SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS
• Applicant: Synthes (Usa)
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Oct 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Porous Polyethylene implants are intended for use in non-load bearing applications in craniofacial reconstruction, cosmetic surgery, and repair of craniofacial trauma.

Device Story

Synthes Porous Polyethylene Implants consist of ultra-high molecular weight polyethylene (UHMWPE), optionally combined with titanium mesh. Implants feature an interconnected, open-pore structure designed to facilitate tissue ingrowth. Available in various shapes and dimensions as porous or porous/smooth sheets. Intended for single-patient use in non-load bearing craniofacial applications, including reconstruction, cosmetic surgery, and trauma repair. Operated by surgeons in clinical settings to restore skeletal anatomy.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Materials: Ultra-high molecular weight polyethylene (UHMWPE) and titanium. Structure: Interconnected, open-pore architecture. Form factor: Sheets of various shapes/dimensions, porous or porous/smooth. Application: Non-load bearing craniofacial implants.

Indications for Use

Indicated for patients requiring non-load bearing craniofacial reconstruction, cosmetic surgery, or repair of craniofacial trauma.

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

• 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

Submission Summary (Full Text)

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K051879

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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)<br>1302 Wrights Lane East<br>West Chester, PA 19380<br>[phone] |
| | 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<br>Titanium Mesh<br>Porex Surgical, Inc.: MedPor Barrier Surgical Implant Biomaterials<br>Porex Medical: Medpor Surgical Implants<br>ePor Inc.: Porous HDPE Surgical Implants |
| | Device Description: | Synthes porous polyethylene implants are made from ultra-high<br>molecular weight polyethylene (UHMWPE) or a combination of<br>UHMWPE and titanium for use in anatomical reconstruction of the<br>craniofacial skeleton. These implants are available, with and<br>without embedded titanium, in porous and porous/smooth sheets of<br>various shapes and dimensions. The interconnected, open pore<br>structure of Synthes porous polyethylene implants allows for tissue<br>ingrowth. Synthes porous polyethylene implants are intended for<br>single-patient use only.<br><br>Synthes porous polyethylene implants are intended for use in non-<br>load bearing applications in craniofacial reconstruction, cosmetic<br>surgery, and repair of craniofacial trauma. |
| | Substantial<br>Equivalence: | Documentation was provided which demonstrated the Synthes<br>Porous Polyethylene Implants are substantially equivalent to other<br>legally marketed devices.<br><br>The term "substantial equivalence" as used in this 510(k)<br>notification is limited to the definition of substantial equivalence<br>found in the Federal Food, Drug and Cosmetic Act, as amended and<br>as applied under 21CFR 807, Subpart E under which a device can<br>be marketed without premarket approval or reclassification. A<br>determination of substantial equivalency under this notification is<br>not intended to have any bearing whatsoever on the resolution of<br>patent infringement suits or any other patent matters. No<br>statements related to, or in support of substantial equivalence herein<br>shall be construed as an admission against interest under the US<br>Patent Laws or their application by the courts. |

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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 [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,

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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| 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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