STRYKER CUSTOM TI IMPLANT

K052871 · Stryker Leibinger · GXN · Dec 16, 2005 · Neurology

Device Facts

• Record ID: K052871
• Device Name: STRYKER CUSTOM TI IMPLANT
• Applicant: Stryker Leibinger
• Product Code: GXN · Neurology
• Decision Date: Dec 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker® Custom Ti Implant is a titanium-mesh implant that is designed to custom-fit a patient's defect. This implant will utilize patient C.T. scan data to produce a custom-contoured titanium or titanium mesh implant that optimally fits each patient. The unique process of developing a Stryker® Custom Ti Implant converts patient CT-Scan data into 3-D images. These images are used to create anatomical models which are then used to build the customized implant.

Device Story

Device is a patient-specific, custom-contoured titanium or titanium mesh implant. Input consists of patient CT scan data; data is converted into 3D images to create anatomical models; models are used to manufacture the custom implant. Intended for surgical correction of mandibular, maxillofacial, or craniofacial bone trauma/defects. Used by surgeons in clinical settings. Benefit is an implant that optimally fits the patient's specific anatomical defect.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium or titanium mesh material. Custom-contoured form factor based on patient-specific CT data. Manufacturing process involves conversion of CT data to 3D images and anatomical models.

Indications for Use

Indicated for patients requiring correction of trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.

Regulatory Classification

Identification

A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.

Predicate Devices

• Stryker Custom Cranial Implant (K043250)
• Synthes (USA) Patient Specific Cranial/Craniofacial Implants (K033868)

Submission Summary (Full Text)

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

# 510(K) SUMMARY OF SAFETY AND EFFECTIVE

Stryker® Custom Ti Implant

#### General Information

DEC 1 6 2005

| Proprietary Name: | Stryker® Custom Ti Implant |
|--------------------------------|--------------------------------------------------------------------------------------|
| Common Name: | Preformed Plate |
| Proposed Regulatory Class: | Class II |
| Device Classification: | GXN (21 CFR 882.5330)<br>Plate, Cranioplasty, Preformed, Non-Alterable |
| Submitter: | Stryker Leibinger<br>4100 East Milham Avenue<br>Kalamazoo, MI 49001<br>269-323-4226 |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 8010177 |
| Contact Person: | Wade T. Rutkoskie<br>Manager, RA/QA<br>Phone: [phone]<br>Fax:<br>269-323-4215 |
| Summary Preparation Date: | October 4, 2005 |

### Intended Use

The Stryker® Custom Ti Implant is a titanium-mesh implant that is designed to custom-fit a patient's defect. This implant will utilize patient C.T. scan data to produce a custom-contoured titanium or titanium mesh implant that optimally fits each patient. The unique process of developing a Stryker® Custom Ti Implant converts patient CT-Scan data into 3-D images. These images are used to create anatomical models which are then used to build the customized implant.

## Substantial Equivalency Information

The Stryker® Custom Ti Implant is substantially equivalent to the Stryker Custom Cranial Implant (K043250) and Synthes (USA) Patient Specific Cranial/Craniofacial Implants (K033868). The Stryker Custom Ti Implants will be manufactured using the same method as the Stryker Custom Cranial Implant (K043250) using titanium or titanium mesh similar to the Synthes (USA) Patient Specific Cranial/Craniofacial Implants (K033868).

The implant will be designed and molded for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.

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

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 human figures inside of it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circle around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 16 2005

Mr. Wade T Rutkoskie Stryker Leibinger 4100 East Milham Ave Kalamazoo, Michigan 49001

Re: K052871

Trade/Device Name: Stryker Custom Ti Implant Regulation Number: 21 CFR 882.5330 Regulation Name: Plate, Cranioplasty, Preformed, non-alterable Regulatory Class: II Product Code: GXN Dated: November 9, 2005 Received: November 22, 2005

Dear Mr. Rutkoskie:

We have reviewed your Section 510(k) premarket notification of intent to market the device w & nare reviewed 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 for use sured in the energy, 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 r ou may a 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 (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.

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

#### Page 2 - Wade Rutkoskie

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,

Mark H. Milliken

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

Enclosure

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

K052871/S

Page 1 of 1

510(k) Number (if known): K

Device Name: Stryker Custom Ti Implant

Indications For Use:

The Stryker® Custom Ti Implant is designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial or craniofacial bone.

Prescription Use
(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 IF NEFIDED)

Concurrence of CDRH, Office of device Evaluation (ODE)

Mark A. Millerson

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

Page / of /

~10(k) Number

(Posted November 13, 2003)