SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS

K033868 · Synthes (Usa) · GXN · Jun 21, 2004 · Neurology

Device Facts

• Record ID: K033868
• Device Name: SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS
• Applicant: Synthes (Usa)
• Product Code: GXN · Neurology
• Decision Date: Jun 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes (USA) Patient Specific Cranial/Craniofacial Implant is intended to replace bony voids in the cranial and/or craniofacial skeleton.

Device Story

Synthes Patient Specific Cranial/Craniofacial Implants are preformed, patient-specific implants designed to fill bony voids in the cranial or craniofacial skeleton. The implants are manufactured from CP Titanium and PEEK. They range in size from 10 x 10 mm to 200 x 200 mm. The device is used by surgeons in a clinical setting to reconstruct cranial or craniofacial defects. The implants are attached to the native bone using standard Synthes cranial and craniofacial plates and screws (1.3 mm to 2.0 mm). By providing a pre-shaped, custom-fit solution, the device restores skeletal anatomy, potentially improving patient outcomes in reconstructive procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: CP Titanium and PEEK. Form factor: Preformed, patient-specific implants ranging from 10x10 mm to 200x200 mm. Attachment: Standard cranial/craniofacial plates and screws (1.3 mm to 2.0 mm).

Indications for Use

Indicated for patients requiring replacement of bony voids in the cranial and/or craniofacial skeleton.

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

• Porex Medical: MEDPOR Porous Polyethylene Cranial Implants

Submission Summary (Full Text)

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JUN 2 1 2004

KO33868 rage

## Summary of Safety and Effectiveness Information [510(k) Summary]

| SPONSOR: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone]<br>Contact: Lisa M. Boyle |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Synthes (USA) Patient Specific Cranial/Craniofacial Implants |
| CLASSIFICATION: | Class II § 21 CFR 882.5330: Plate, Cranioplasty, preformed, non-alterable |
| PREDICATE DEVICE: | Porex Medical: MEDPOR Porous Polyethylene Cranial Implants |
| DEVICE DESCRIPTION: | The Synthes Patient Specific Cranial/Craniofacial Implant replaces bony<br>voids in the cranial/craniofacial skeleton. The implants are preformed /<br>pre-shaped to fit the anatomy of the patient, will range in size from 10 x 10<br>mm to 200 x 200 mm, and attach to the native bone using standard Synthes<br>cranial and craniofacial plates and screws in sizes 1.3 mm through 2.0 mm.<br>The Synthes Patient Specific Cranial/Craniofacial Implants are<br>manufactured from CP Titanium and PEEK. |
| INTENDED USE: | Synthes (USA) Patient Specific Cranial/Craniofacial Implant is intended to<br>replace bony voids in the cranial/craniofacial skeleton. |
| SUBSTANTIAL<br>EQUIVALENCE: | Comparative information presented supports substantial equivalence. |

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 1 2004

Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russel Road Paoli, PA 19301

Re: K033868

. 1805000
Trade/Device Name: Synthes (USA) Patient Specific Cranial/Craniofacial Implants Regulation Number: 21 CFR 882.5330 Regulation Name: Plate, cranioplasty, preformed, non-alterable Regulatory Class: Class II Product Code: GXN Dated: December 11, 2003 Received: December 12, 2003

Dear Ms. Boyle:

We have reviewed your Section 510(k) premarket notification of intent to market the device w t nave review a your we determined the device is substantially equivalent (for the indications ferenced a over and mansure) to legally marketed predicate devices marketed in interstate for use suated in the encrease in the enactment date of the Medical Device Amendments, or to commerce prox to they 20, 1978, is 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) therefore, is as of the Act include requirements for annual registration, listing of general obliness provision 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to bach adderal 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 I teast of actived a determination that your device complies with other requirements of the Act that i Drineal statutes and regulations administered by other Federal agencies. You must or any I odetar statuation and stime to be not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI I art 607); idooning (21 CFR Part 820); and if applicable, the electronic form in the quand on control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Lisa M. Boyle

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin makemig your advice of your device to a legally
premarket notification. The FDA finding of substantial equirales of your device to a lega premarket notification. The PDA inding of substantial equive 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
rs in the may be and 11, 2011 1650 - All seculation negulation entitled If you desire specific advice for your ac vice on bean note the regulation entitled.
contact the Office of Compliance at [phone]. Also, please note the regulation of t contact the Office of Collipilalice at [phone] (21 Part 807.97). You may obtain "Misbranding by reference to premarket notificas under the Act from the Division of Small
other general information on your responsibilities under the Act from pumber (800) 6 other general information on your responsion.com its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its today demanain html Manufacturers, International and Consultive Picerouser and and and main.html

Sincerely yours,
Mark A. Wilkerson

Celia M. Witten, Ph.D., M.D. 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

Page _ 1 ___ of __ of __ I

| 510(k) Number (if known): | K033868 |
|---------------------------|--------------------------------------------------------------|
| Device Name: | Synthes (USA) Patient Specific Cranial/Craniofacial Implants |

Indications:

Synthes (USA) Patient Specific Cranial/Craniofacial Implant is intended to replace bony voids in the cranial and/or craniofacial skeleton.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR
Over-The-Counter Use__

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

510(k) Number K033868