STRYKER PATIENT SPECIFIC POLYMER IMPLANT

K043250 · Stryker Leibinger · KKY · Apr 15, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K043250
• Device Name: STRYKER PATIENT SPECIFIC POLYMER IMPLANT
• Applicant: Stryker Leibinger
• Product Code: KKY · General, Plastic Surgery
• Decision Date: Apr 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3500
• 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 designed to correct trauma or defects in mandibular, maxillofacial, or craniofacial bone; fabricated from Surgical Simplex P Radiopaque Bone Cement (PMMA). Device provides custom-molded, nonresorbable, biocompatible structural replacement for amorphous defects not addressed by standard implants. Used by surgeons to restore bone anatomy; maintains shape post-implantation to provide skull protection. Clinical benefit derived from decades of established PMMA safety and efficacy in orthopaedic and oral surgery applications.

Clinical Evidence

No clinical data provided. Safety and effectiveness established via historical clinical use of the constituent material (Surgical Simplex P Radiopaque Bone Cement) over several decades.

Technological Characteristics

Material: Polymethylmethacrylate (PMMA) (Surgical Simplex P Radiopaque Bone Cement). Nonresorbable, biocompatible, porous composite. Form factor: Patient-specific, custom-molded to anatomical defect. Energy source: None (passive implant).

Indications for Use

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

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

• Hard Tissue Replacement - Patient Match Implant (K924935)
• Hard Tissue Replacement - Malleable Facial Implant
• Hard Tissue Replacement - MX (K904111)
• Surgical Simplex P Radiopaque Bone Cement (Howmedica Osteonics N-17-004)

Submission Summary (Full Text)

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K043250 page 1/2

APR 1 5 2005

## 510(K) SUMMARY OF SAFETY AND EFFECTIVEN

Stryker® Patient Specific Polymer Implant

#### General Information

| Proprietary Name: | Stryker® Patient Specific Polymer Implant |
|--------------------------------|---------------------------------------------------------------------------------------------|
| Common Name: | PMMA |
| Proposed Regulatory Class: | Class II |
| Device Classification: | KKY (882.3500) |
| Submitter: | Stryker Leibinger<br>4100 East Milham Avenue<br>Kalamazoo, MI 49001<br>269-323-4226 |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 1226001 |
| Contact Person: | Wade T. Rutkoskie<br>Associate Manager RA QA<br>Phone: [phone]<br>Fax:<br>269-323-4215 |
| Summary Preparation Date: | November 20, 2004 |

#### 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.

### Substantial Equivalency Information

The Stryker® Patient Specific Polymer Implant is substantially equivalent to the Hard Tissue Replacement - Patient Match Implant K924935, Hard Tissue Replacement --Malleable Facial Implant, Hard Tissue Replacement--MX K904111, Surgical Simplex P Radiopaque Bone Cement (Howmedica Osteonics N-17-004).

The Stryker® Patient Specific Polymer Implant is manufactured by Doctor's Research The Stryker® Patient Specific Polymer Implant is made from PMMA, Group. specifically Surgical Simplex P Radiopaque Bone Cement.

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K043250 page 2/2

Surgical Simplex P Radiopaque Bone Cement is a biocompatible nonresorbable material that will maintain its shape after implantation and provide protection to the skull. Surgical Simplex P Radiopaque Bone Cement is a porous composite material comprised of polymethylmethacrylate (PMMA). PMMA has been used for decades in various applications from clinical orthopaedics to oral surgery since the 10000's. Clinical use of Surgical Simplex P Radiopaque Bone Cement has been used in thousands of cases proving to be safe and effective.

The safety and effictiveness of Surgical Simplex P Radiopaque Bone Cement has been established over several decades. The implant will be designed and molded for a specific patient to correct trauma and/or defects in mandibulsa, maxilloficial, or craniofacial bone. A Patient Specific Polymer Implant provides for replacemant of an amorphous shaped implant not contained within standard product offerings.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized wing or feather shapes.

APR 1 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Nathan M, Miersma Regulatory Affairs Representative Stryker 4280 Commercial Avenue, Suite A Portage Commerce Park Portage, Michigan 49002

Re: K043250

Trade/Device Name: Stryker Leibinger Patient Specific Polymer Regulation Number: 21 CFR 878.3500 Regulation Name: Polytetrafluroethylene with carbon fibers composite implant material Regulatory Class: II Product Code: KKY Dated: March 13, 2005 Received: March 15, 2005

Dear Mr. Miersma:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalcnt (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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Scctions 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Nathan M, Miersma

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/cdrl/industry/support/index.html.

Sincerely yours,

Ru. U. Ru

_Miriam C. Provost, Ph.D. Acting 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

510(k) Number (if known): K043250

Device Name: Stryker Leibinger Patient Specific Polymer

Indications For Use:

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

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

E. K.

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