OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT

K072601 · Osteosymbionics, LLC · GXP · Dec 10, 2007 · Neurology

Device Facts

• Record ID: K072601
• Device Name: OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT
• Applicant: Osteosymbionics, LLC
• Product Code: GXP · Neurology
• Decision Date: Dec 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OsteoSymbionics Patient Specific Cranial Implants are designed individually for each patient to correct defects in craniofacial bone.

Device Story

Patient-specific cranial implants fabricated from polymethyl methacrylate (PMMA) to fill cranial/craniofacial skeletal defects. Input: patient CT imaging data used to design and size individual implants. Output: custom-shaped prosthetic plate. Usage: surgical implantation by clinicians to restore cranial structure; attached to native bone using commercially available cranioplasty fasteners. Provided non-sterile; requires sterilization prior to use. Benefits: provides anatomical fit for specific patient defects.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and material safety profile.

Technological Characteristics

Material: Polymethyl methacrylate (PMMA). Form factor: Patient-specific, custom-shaped cranial/craniofacial plates. Connectivity: None. Sterilization: Provided non-sterile; requires user-performed sterilization. Sensing/Actuation: None (passive implant).

Indications for Use

Indicated for patients requiring correction of craniofacial bone defects.

Regulatory Classification

Identification

Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.

Predicate Devices

• Synthes Patient Specific Cranial/Craniofacial Implants (K033868)
• Stryker Patient.Specific Polymer Implant (K043250)
• Codman Cranioplastic (K873689)

Submission Summary (Full Text)

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K07260/ pge 14

Image /page/0/Picture/1 description: The image shows the logo for OsteoSymbionics. The logo consists of the word "osteo" followed by a stylized symbol that resembles a circle with a diagonal line through it. The word "symbionics" appears to the right of the symbol, with the letters in a smaller font size. The letters "TM" are in superscript.

## 510(k) Summary of Safety and Effectiveness
(as required by 21 CFR § 807.92)

| 510(k) Submitter | OsteoSymbionics, LLC<br>1768 East 25th Street<br>Cleveland, Ohio 44114 | |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person | Ms. Cynthia Brogan, President<br>Phone: [phone]<br>e-mail: [e-mail] | DEC 1 0 2007 |
| Date Prepared | September 12, 2007 | |
| Device Name | <i>Proprietary Name:</i> OsteoSymbionics Patient-Specific Cranial Implant<br><i>Common Name:</i> patient-specific cranial implant<br><i>Classification Name:</i> "plate, cranioplasty, preformed, non-alterable," a<br>class II device in accordance with 21 CFR § 882.5330 | |
| Device Description | The OsteoSymbionics Patient Specific Cranial Implants are individually<br>sized and shaped implantable prosthetic cranioplasty plates intended to<br>fill defects in a specific patient's cranial/craniofacial skeleton. The<br>implants are composed of polymethyl methacrylate and are fabricated<br>using the patient's CT imaging data. The devices are provided non-<br>sterile for sterilization prior to implantation and are attached to the<br>native bone with commercially available cranioplasty fasteners. | |
| Indication for Use | The OsteoSymbionics Patient-Specific Cranial Implants are designed<br>individually for each patient to correct defects in craniofacial bone. | |
| Substantial<br>Equivalence | The OsteoSymbionics Patient-Specific Cranial Implants are substantially<br>equivalent in terms of safety and effectiveness to the following legally<br>marketed devices:<br>Synthes Patient Specific Cranial/Craniofacial Implants - K033868<br>Synthes (USA)<br>Stryker® Patient.Specific Polymer Implant - K043250<br>Stryker Liebinger<br>Codman Cranioplastic - K873689<br>Codman Division of Johnson & Johnson | |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC】0 2007

OsteoSymbionics, LLC % Ms. Cynthia Brogan President 1768 East 25th Street Cleveland, OH 44114

Re: K072601

Trade/Device Name: OsteoSymbionics Patient-Specific Cranial Implant Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: Class II Product Code: GXP, GXN Dated: September 12, 2007 Received: September 14, 2007

Dear Ms. Brogan:

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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Cynthia Brogan

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincerely yours,

Mark M. Milliman

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

Enclosure

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| Indications for Use Statement |
|-------------------------------|
|-------------------------------|

| 510(k) Number: | K072601 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | OsteoSymbionics Patient-Specific Cranial Implants |
| Indications for Use: | The OsteoSymbionics Patient Specific Cranial Implants are designed individually for each patient to correct defects in craniofacial bone. |

| Prescription Use | X | AND/OR | Over-The-Counter Use | No |
|-----------------------------|---|--------|------------------------|----|
| (Part 21 CFR 801 Subpart D) | | | (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)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

| 510(k) Number | K072601 |
|---------------|---------|
|---------------|---------|

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