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 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.

AI/ML Overview

Response:
The provided documentation does not contain information regarding detailed acceptance criteria, device performance metrics, or specific studies that would typically be conducted for performance evaluation of a device. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, particularly highlighting an online ordering system modification, rather than presenting a clinical or performance study with acceptance criteria.

Therefore, the requested information elements (1 through 9) cannot be extracted from the provided text. The document refers to the device being "verified and validated according [to] Stryker procedures for product design and development" and that "The validation proves the safety and effectiveness of the system," but it does not detail these procedures, validation studies, or their results, nor does it provide the specific data requested in your prompt.

It's important to note that this 510(k) submission primarily addresses the addition of an online ordering system and its impact on substantial equivalence, rather than a new design requiring extensive performance studies with specific statistical measures.

Summary

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JUL 1 4 2011

510(k) Summary

Name and Address of Sponsor:	Howmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430
510(k) Contact Person:	Claudia WiesemannStryker Leibinger GmbH & Co. KGBötzinger Straße 41D-79111 FreiburgGermanyPhone: (+49) 761 45 12 4093Fax: (+49) 761 4512 49 283Email: claudia.wiesemann@stryker.com
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 carbonfibers compositeimplant material, 21 CFR §878.3500Preformed 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:

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® PatientSpecific PolymerImplant	Stryker® PatientSpecific PolymerImplant	MEDPOR CustomizedSurgical. Implant

	Subject Device	Predicate Device I	Predicate Device II
510(k) Number		K103010	K083621
Indications forUse	The Stryker PatientSpecific PolymerImplant is designedindividually for eachpatient to correct traumaand/or defects inmandibular,maxillofacial, orcraniofacial bone.	The Stryker PatientSpecific PolymerImplant is designedindividually for eachpatient to correct traumaand/or defects inmandibular,maxillofacial, orcraniofacial bone.	The MEDPORCustomized SurgicalImplant is intended forthe augmentation orrestoration of bonycontour in craniofacialdefects.
Product Code	KKY, GWO	KKY, GWO	JOF, GWO
Material/Chemicalcomposition	Simplex P Bone Cement	Simplex P Bone Cement	A linear, high-densitypolyethylene 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(Passwordprotected)	X		X
Design Approval
Fax/Mail Approval	X	X	X
Online Approval(Passwordprotected)	X	-	X
Online assessmentof 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 (800) 638-2041 or (301) 796-7100 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

Regulation Number and Section

§ 882.5320 Preformed alterable cranioplasty plate.

(a)
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.(b)
Classification. Class II (performance standards).