SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS

K111323 · Synthes, Inc. · KKY · Nov 16, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K111323
• Device Name: SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS
• Applicant: Synthes, Inc.
• Product Code: KKY · General, Plastic Surgery
• Decision Date: Nov 16, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes SynPOR HD Porous Polyethylene Three Dimensional Implants are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton. Specific indications (SynPOR HD Ocular Spheres): • Ocular reconstruction • Socket preservation Specific indications (SynPOR HD Facial Shapes): • Enhancement of the malar and chin • Correction of deficiencies of the malar and chin

Device Story

SynPOR HD Porous Polyethylene Three Dimensional Implants consist of high-density porous polyethylene (HDPE) shapes; designed for craniomaxillofacial reconstruction and augmentation. Implants include facial shapes (chin/malar) for skeletal contouring and ocular spheres for volume restoration in eviscerated or enucleated eye globes. Porous structure facilitates fibrovascular ingrowth. Delivered sterile for single-patient use; not for resterilization. Used by surgeons in clinical settings to address skeletal deficiencies or aesthetic/reconstructive needs. Implants provide structural support and volume, potentially improving patient facial symmetry and ocular socket function.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

High-density porous polyethylene (HDPE) material; porous structure allows fibrovascular ingrowth. Form factors include facial shapes (chin, malar) and ocular spheres. Sterile, single-use device.

Indications for Use

Indicated for patients requiring craniomaxillofacial skeleton augmentation or reconstruction, including ocular reconstruction, socket preservation, and enhancement or correction of malar and chin deficiencies.

Regulatory Classification

Identification

A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.

Predicate Devices

• AOC Porous Polyethylene Surgical Implants (K080507)

Submission Summary (Full Text)

{0}------------------------------------------------

NOV 162

Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in a stylized, bold, black font. To the left of the word is a circular logo with a design inside. A registered trademark symbol is located to the right of the word.

::n

バリアママ 1۰-2

| 510(k) Summary | Page 1 of 2 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | August 30, 2011 |
| Submitter | SYNTHES (USA) |
| | 1301 Goshen Parkway<br>West Chester, PA 19380<br>United States of America |
| Contact | Contact: Alan T. Haley<br>[e-mail]<br>[phone] |
| Trade Name | Synthes SynPOR HD Porous Polyethylene Three Dimensional Implants<br>Synthes SynPOR HD Facial Shape System<br>Synthes SynPOR HD Ocular Spheres |
| Common Name | Porous High Density Polyethylene (HDPE) Implant |
| Classification<br>Name | Material, polytetrafluoroethylene vitreous carbon, for maxillofacial<br>reconstruction, Class II, 21 CFR 878.3500 |
| Product Code | KKY |
| Predicate Devices | AOC Porous Polyethylene Surgical Implants (K080507) |
| Device<br>Description | SynPOR HD Porous Polyethylene Three Dimensional Implants are<br>devices intended for ocular reconstruction and socket preservation,<br>enhancement of the midface and mandibular skeleton, and correction of<br>deficiencies of the midface and mandible. The porous structure of the<br>HDPE material allows for fibrovascular ingrowth. |
| | The implants include facial shapes (chin and malar implants for aesthetic<br>and reconstructive surgery to augment the contours of the craniofacial<br>skeleton) and ocular spheres (for restoring the volume of an eviscerated<br>or enucleated eye globe). |
| | SynPOR HD Porous Polyethylene Implants are delivered sterile for single<br>patient use and should not be resterilized. |
| Intended Use | Synthes SynPOR HD Porous Polyethylene Three Dimensional Implants<br>are intended for the augmentation or reconstruction of the<br>craniomaxillofacial skeleton. |
| | Specific indications (SynPOR HD Ocular Spheres):<br>• Ocular reconstruction<br>• Socket preservation |
| | Specific indications (SynPOR HD Facial Shapes):<br>• Enhancement of the malar and chin<br>• Correction of deficiencies of the malar and chin |

.

{1}------------------------------------------------

【1】132.3

2.fcf2

Page 2 of 2

Image /page/1/Picture/2 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized design inside. The logo and the word "SYNTHES" are both in black, contrasting with the white background. There is a registered trademark symbol to the right of the word.

## 510(k) Summary

Technological Characteristics Synthes SynPOR HD Porous Polyethylene Three Dimensional Implants. are modifications to the predicate and are therefore similar in terms of indications, materials, principles of operation, dimensions, and design. It was determined that none of the modifications impact safety and effectiveness.

Substantial Equivalence to Predicate Devices The modified devices are similar to the predicate devices identified above in terms of indications, materials, principles of operation, dimensions, and device design. The information presented in this submission supports substantial equivalence of the Synthes SynPOR HD Porous Polyethylene Three Dimensional Implants to the predicate device. ·

(end of summary)

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the perimeter of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-W066-G609 Silver Spring, MD 20993-0002

NOV 1 6 2011

Synthes. Inc. % Mr. Alan T. Haley Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K111323

Trade/Device Name: Synthes SynPOR HD Porous Polyethylene Three Dimensional Implants Regulation Number: 21 CFR 878.3500 Regulation Name: Polyetrafluoroethylene with carbon fibers composite implant material Regulatory Class: II Product Code: KK Y Dated: November 11, 2011 Received: November 14, 2011

Dear Mr. Haley:

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 (för 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

{3}------------------------------------------------

Page 2 - Mr. Alan T. Haley

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 1000-1050,

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR, Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.

Sincerely vours.

Erin A. Keith

for Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

| Indications for Use Statement | |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known): | K111323 |
| Device Name: | Synthes SynPOR HD Porous Polyethylene Three Dimensional Implants |
| Indications for Use: | Synthes SynPOR HD Porous Polyethylene Three Dimensional Implants are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton. |
| | Specific indications (SynPOR HD Ocular Spheres): <ul><li>Ocular reconstruction</li><li>Socket preservation</li></ul> |
| | Specific indications (SynPOR HD Facial Shapes): <ul><li>Enhancement of the malar and chin</li><li>Correction of deficiencies of the malar and chin</li></ul> |
| Prescription Use X (Part 21 CFR 801 Subpart D) | AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart C) |

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF needed)

:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel D. Kamo de MXM

(Division Sign-Off) Division of Surgical, Orthopedic, . . and Restorative Devices

510(k) Number K111323