STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT

K111065 · Howmedica Osteonics Corp. Dba Stryker Orthopeadics · GWO · Jul 14, 2011 · Neurology

Device Facts

• Record ID: K111065
• Device Name: STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT
• Applicant: Howmedica Osteonics Corp. Dba Stryker Orthopeadics
• Product Code: GWO · Neurology
• Decision Date: Jul 14, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Patient Specific Polymer Implant is designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.

Device Story

Patient-specific implant; pre-formed plate manufactured from Simplex P bone cement. Input: patient CT scans provided by surgeon. Process: custom shaping of polymer to match bony defect; online ordering/approval via eRequest Lifecycle system. Output: patient-specific implant. Usage: clinical setting; surgeon-operated. Fixation: compatible Stryker plate and screw systems. Benefit: anatomical restoration of craniofacial/maxillofacial defects.

Clinical Evidence

Bench testing only; no clinical data provided. Safety and effectiveness verified through product design and development procedures.

Technological Characteristics

Material: Simplex P bone cement. Form factor: pre-formed, patient-specific plate. Connectivity: online ordering/upload system (eRequest Lifecycle). Sterilization: not specified. Software: online portal for image transfer and design approval.

Indications for Use

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

Regulatory Classification

Identification

A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.

Predicate Devices

• Stryker® Patient Specific Polymer Implant (K103010)
• MEDPOR Customized Surgical Implant (K083621)

Submission Summary (Full Text)

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JUL 1 4 2011

# 510(k) Summary

| Name and Address of Sponsor: | Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact Person: | Claudia Wiesemann<br>Stryker Leibinger GmbH & Co. KG<br>Bötzinger Straße 41<br>D-79111 Freiburg<br>Germany<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Summary Prepared: | April 14, 2011 |
| Device Trade Name: | Stryker® Patient Specific Polymer Implant |
| Common Name: | Preformed Alterable Cranioplasty Plate, PMMA |
| Classification Name and Reference: | Polytetrafluoroethylene with carbon<br>fibers composite<br>implant material, 21 CFR §878.3500<br>Preformed alterable cranioplasty plate 21 CFR §882.5320 |
| Proposed Regulatory Class: | Class II |
| Product Code: | KKY, GWO |

# Description:

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the Stryker® Patient Specific Polymer Implant components with an online ordering system.

# Indications for Use:

The Stryker Patient Specific Polymer Implant is designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.

#### Proposed Modification:

The product will now be supplied with an online ordering system called eRequest Lifecycle. The manufacturing location and processes have not changed since originally described in K103010.

# Device Description:

The Stryker Patient Specific Polymer Implant is a pre-formed plate made of cured Simplex P bone cement that is shaped to match a specific patient's bony defect based on CT scans provided by the surgeon. The plate is fixed into place using compatible Stryker plate and screw systems.

# Substantial Equivalence:

The Stryker Patient Specific Polymer Implant has been verified and validated according Stryker procedures for product design and development. The validation proves the safety and effectiveness of

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the system. The information provided by Stryker in this 510(k) application was found to be substantially equivalent with predicate devices such as the 510(k) clearance of:

- · Stryker® Patient Specific Polymer Implant (K103010)
- MEDPOR Customized Surgical Implant (K083621)

The following matrix demonstrates the substantially equivalence of the Stryker® Patient Specific Polymer Implant with the two predicates (K103010 and K083621).

| | Stryker® Patient<br>Specific Polymer<br>Implant | Stryker® Patient<br>Specific Polymer<br>Implant | MEDPOR Customized<br>Surgical. Implant |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | |
| | Subject Device | Predicate Device I | Predicate Device II |
| 510(k) Number | | K103010 | K083621 |
| Indications for<br>Use | The Stryker Patient<br>Specific Polymer<br>Implant is designed<br>individually for each<br>patient to correct trauma<br>and/or defects in<br>mandibular,<br>maxillofacial, or<br>craniofacial bone. | The Stryker Patient<br>Specific Polymer<br>Implant is designed<br>individually for each<br>patient to correct trauma<br>and/or defects in<br>mandibular,<br>maxillofacial, or<br>craniofacial bone. | The MEDPOR<br>Customized Surgical<br>Implant is intended for<br>the augmentation or<br>restoration of bony<br>contour in craniofacial<br>defects. |
| Product Code | KKY, GWO | KKY, GWO | JOF, GWO |
| Material/Chemical<br>composition | Simplex P Bone Cement | Simplex P Bone Cement | A linear, high-density<br>polyethylene biomaterial |
| Ordering System | | | |
| Request Initiation | | | |
| Fax/Mail Order | X | X | X |
| Online Order | X | - | X |
| Image Data Transfer | | | |
| CD on disk via mail | X | X | X |
| Online Upload<br>(Password<br>protected) | X | | X |
| Design Approval | | | |
| Fax/Mail Approval | X | X | X |
| Online Approval<br>(Password<br>protected) | X | - | X |
| Online assessment<br>of virtual implant | X | - | X |
| Use of CT scans | X | X | X |

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Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized human figure with three overlapping bodies, and the text "DEPARTMENT OF HEALTH &" is written vertically along the left side of the figure. The text is oriented so that it reads from bottom to top.

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

Howmedica Osteonics Corp. dba Stryker Orthopedics c/o Ms. Claudia Wiesemann Regulatory Affairs Specialist 325 Corporate Drive Mahwah, NJ 07430

JUL 1 4 2011

Re: K111065

Trade/Device Name: Stryker® Patient Specific Polymer Implant Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed alterable cranioplasty plate Regulatory Class: Class II Product Code: GWO, KKY Dated: April 14, 2011 Received: April 18, 2011

Dear Ms. Wiesemann:

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. 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

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Page 2 - Ms. Claudia Wiesemann

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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Keoia Alexander

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

KIII065 510(K) Number (if known): _

Device Name: Stryker® Patient Specific Polymer Implant

Indications for Use:

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

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K111065