MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079

K101835 · Porex Surgical, Inc. · HBW · Dec 3, 2010 · Neurology

Device Facts

• Record ID: K101835
• Device Name: MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079
• Applicant: Porex Surgical, Inc.
• Product Code: HBW · Neurology
• Decision Date: Dec 3, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MEDPOR Fixation System - Cranial is intended for use in cranial surgery to fixate MEDPOR cranial implants to the surrounding cranial skeleton.

Device Story

The MEDPOR Fixation System - Cranial is a plate and screw system used in cranial surgery to secure MEDPOR polyethylene implants to the cranial skeleton. The system consists of grade 4 titanium plates (ASTM F67) and 6-4 ELI titanium alloy bone/implant screws (ASTM F136), accompanied by surgical stainless steel installation instruments. Components are color-anodized for surgeon identification: blue-anodized plates match blue-anodized bone screws, while magenta-anodized plates match magenta-anodized implant screws. The device is supplied sterile via ethylene oxide, with instruments and unused components capable of steam resterilization. It is intended for use by surgeons in a clinical/OR setting to provide rigid fixation of cranial implants.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Plates: Grade 4 CP Titanium (ASTM F67). Screws: 6-4 ELI Titanium Alloy (ASTM F136). System includes color-anodized components for identification. Sterilization: Ethylene oxide (initial), steam (resterilization of instruments/unused components). Mechanical fixation system.

Indications for Use

Indicated for use in cranial surgery to fixate MEDPOR cranial implants to the surrounding cranial skeleton.

Regulatory Classification

Identification

A cranioplasty plate fastener is a screw, wire, or other article made of tantalum, vitallium, or stainless steel used to secure a plate to the patient's skull to repair a skull defect.

Predicate Devices

• OSTEOTRANS-MX Bioabsorbable Bone Fixation System (K073006)
• Synthes Low Profile Neuro System (K022012)
• Synthes Craniofacial Plates (K021642)
• SMF Titanium (TI) Alloy Bone Screws (K963546)
• Stryker Leibinger Universal Neuro System (K031659)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for POREX Surgical Products Group. The word "POREX" is in large, bold, black letters. Below the word "POREX" is the text "SURGICAL PRODUCTS GROUP" in a smaller font size.

## 510(k) SUMMARY

DEC - 3 2010

KI 01 835

Date of Summary: September 17, 2010

#### Manufacturer and Submitter:

Porex Surgical, Inc. 15 Dart Road Newnan, GA 30265 Tel: [phone] Fax: [phone]

Contact: Stephanie Fullard E-mail: [e-mail]

Trade Name: MEDPOR® Fixation System - Cranial

Common Name: Plates and Screws

Class: II, 21 CFR 882.5360 - Cranioplasty plate fastener

Product Code: HBW

## Substantially equivalent to:

- 1) Takiron Co., Ltd OSTEOTRANS™-MX Bioabsorbable Bone Fixation System K073006
- 2) Synthes (USA) Synthes Low Profile Neuro System K022012
- 3) Synthes (USA) Synthes (USA) Craniofacial Plates K021642
- 4) Synthes (USA) SMF Titanium (TI) Alloy Bone Screws K963546
- 5) Stryker Leibinger Stryker Leibinger Universal Neuro System K031659

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## Device Description:

The MEDPOR Fixation System - Cranial is a plate and screw system to be used in Cranial Surgery. The components that comprise the system are composed of titanium plates. titanium alloy bone screws, titanium alloy implant screws, and surgical stainless steel instruments for the installation of the plates and screws. The plates are manufactured of grade 4 titanium and adhere to the American Society of Testing Materials (A.S.T.M.) F67 Standard. The bone and implant screws are manufactured of 6-4 ELI titanium that meets the ASTM F136 standard. The implant screws are designed to be used with MEDPOR polyethylene implants manufactured by Porex Surgical under K832283. K922489. K952677, K040364 and K083621. The screws and plates have been color anodized for ease of use by a surgeon. The blue anodized side of the plate corresponds to the blue anodized bone screw and the magenta anodized side of the plate corresponds to the magenta anodized implant screw. The MEDPOR Fixation System -- Cranial is sterilized by ethylene oxide sterilization. The instruments and unused components can be resterilized via steam sterilization.

## Indications for Use:

The MEDPOR Fixation System - Cranial is intended for use in cranial surgery to fixate MEDPOR cranial implants to the surrounding cranial skeleton.

## Technological Characteristics:

Documentation is provided which demonstrates that the MEDPOR Fixation System -Cranial is substantially equivalent to other legally marketed devices. The technological characteristics of the design are substantially equivalent to the predicate devices and any slight differences do not raise new issues of safety and effectiveness.

#### Substantial Equivalence:

The following matrix is a comparison of the MEDPOR Fixation System - Cranial to the predicate devices. The MEDPOR Fixation System - Cranial is substantially equivalent in design and intended use to each of the predicate devices. The MEDPOR Fixation System - Cranial is substantially equivalent in material to the predicate devices that are manufactured from titanium. Titanium has a long history of use in surgical implantable products.

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| Device | Proposed Device | Predicate Device #1 | Predicate Device #2 | Predicate Device #3 | Predicate Device #4 | Predicate Device #5 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | MEDPOR<br>Fixation System<br>- Cranial | OSTEOTRANS-<br>MX Bioabsorbable<br>Bone Fixation<br>System | Synthes Low<br>Profile Neuro<br>System | Synthes<br>Craniofacial<br>Plates | SMF Titanium<br>(TI) Alloy Bone<br>Screws | Stryker<br>Leibenger<br>Universal Neuro<br>System |
| 510(k) Number | This Submission | K073006 | K022012 | K021642 | K963546 | K031659 |
| Device<br>Classification | Class II,<br>Code HBW,<br>Reg. No.<br>882.5360 | Class II,<br>Code GWO, HBW<br>Reg. No.<br>882.5320,<br>882.5360 | Class II,<br>Code JEY, GXR,<br>DZL<br>Reg. No.<br>872.4760,<br>882.5250,<br>872.4880 | Class II,<br>Code JEY<br>Reg. No.<br>872.4760 | Class II,<br>Code DZL<br>Reg. No.<br>872.4880 | Class II,<br>Code JEY<br>Reg. No.<br>872.4760 |
| Intended Use | The MEDPOR<br>Fixation System<br>- Cranial is<br>intended for use<br>in cranial surgery<br>to fixate<br>MEDPOR<br>cranial implants<br>to the<br>surrounding<br>cranial skeleton. | The<br>OSTEOTRANS -<br>MX Bioabsorbable<br>Bone Fixation<br>System is intended<br>for use in trauma<br>and reconstructive<br>procedures of the<br>craniofacial<br>skeleton, including<br>fracture of the<br>cranium, infant<br>craniofacial<br>surgery (i.e.<br>craniosynotosis,<br>congenital<br>malformations),<br>pediatric<br>reconstructive<br>procedures,<br>reconstructive<br>procedures of the<br>cranium,<br>craniotomy flap<br>fixation. | The Synthes Low<br>Profile Neuro<br>System is<br>intended for use<br>in selective<br>trauma of the<br>midface and<br>craniofacial<br>skeleton;<br>craniofacial<br>surgery;<br>reconstructive<br>procedures; and<br>selective<br>orthognathic<br>surgery of the<br>maxilla and chin. | The Synthes<br>Craniofacial<br>Plates are<br>intended for use<br>in selective<br>trauma of the<br>midface and<br>craniofacial<br>skeleton;<br>craniofacial<br>surgery;<br>reconstructive<br>procedures; and<br>selective<br>orthognathic<br>surgery of the<br>maxilla and<br>chin. | The SMF Ti<br>Alloy Bone<br>Screws are<br>intended for<br>craniofacial and<br>mandibular<br>trauma and<br>reconstruction. | The Stryker<br>Leibinger<br>Universal Neuro<br>System is a low-<br>profile plate and<br>screw system<br>intended for<br>osteotomy,<br>craniotomy,<br>stabilization and<br>rigid fixation of<br>craniofacial<br>fractures and<br>reconstruction of<br>non-load bearing<br>areas. |
| Materials | Plates - CP 4<br>Titanium<br>Screws - 6/4 ELI<br>Titanium Alloy | Bone Plates,<br>Meshes and<br>Screws<br>manufactured<br>from composites<br>of Hydroxyapatite<br>and Poly-L-<br>Lactide<br>(HA/PLLA) | Plates -<br>Titanium<br>Screws - Ti-6Al-<br>7Nb Titanium<br>Alloy | Titanium | Titanium Alloy | CP Titanium or<br>Ti6Al4V Alloy |
| Dedicated<br>Instrumentation | Yes | Not Stated | Yes | Yes | Yes | Yes |
| Sterile/<br>Nonsterile | Supplied Sterile | Sterile | Nonsterile or<br>Sterile-packed | Nonsterile or<br>Sterile-packed | Nonsterile or<br>Sterile-packed | Nonsterile |
| Sterilization<br>Methods | Ethylene Oxide<br>& Steam | Not Stated | Steam | Steam | Steam | Steam |

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Porex Surgical, Inc. C/O Stephanie Fullard Regulatory Affairs Manager 15 Dart Road Newnan, GA 30265

Re: K101835

Trade/Device Name: MEDPOR Fixation System - Cranial Regulation Number: 21 CFR 882.5360 Regulation Name: Cranioplasty plate fastener Regulatory Class: Class II Product Code: HBW Dated: November 22, 2010 Received: November 23, 2010

DEC -- 3 2010

Dear Ms. Fullard:

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 iudicions 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, Or ve 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 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

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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/CDRHOffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Keoin Alexander

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Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological, and Ear.

Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

DEC - 3 2010

510(k) Number (if known): K101835

Device Name: MEDPOR® Fixation System - Cranial

Indications for Use: The MEDPOR Fixation System - Cranial is intended for use in cranial surgery to fixate MEDPOR cranial implants to the surrounding cranial skeleton.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number k101835