Patient Contoured Implant-PEEK (PCI-PEEK)

K151382 · KLS Martin L.P. · GXN · Nov 9, 2015 · Neurology

Device Facts

• Record ID: K151382
• Device Name: Patient Contoured Implant-PEEK (PCI-PEEK)
• Applicant: KLS Martin L.P.
• Product Code: GXN · Neurology
• Decision Date: Nov 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Patient Contoured Implant - PEEK (PCI-PEEK) is intended to replace bony voids in the cranial skeleton.

Device Story

Patient Contoured Implant - PEEK (PCI-PEEK) is a preformed, solid or perforated cranial implant manufactured from PEEK. The device is custom-shaped to patient anatomy using CT-based skull models. It is intended for use in healthcare facilities by surgeons to replace bony voids in the cranial skeleton. The implant is fixated to native bone using previously cleared KLS Martin titanium plates and screws. The device is provided sterile via gamma radiation. By providing a patient-specific, pre-contoured fit, the device facilitates reconstruction of cranial defects, potentially improving surgical efficiency and patient outcomes compared to intraoperative manual contouring.

Clinical Evidence

No clinical data. Substantial equivalence determined via bench testing and comparison of technological characteristics. Biocompatibility evaluation performed per ISO 10993-1. LAL endotoxin testing confirmed compliance with < 2.15 EU/device specification.

Technological Characteristics

Material: PEEK (Polyether ether ketone). Form factor: Preformed, solid or solid with holes. Fixation: Titanium plates and screws. Sterilization: Gamma radiation. Connectivity: None (standalone).

Indications for Use

Indicated for patients requiring replacement of bony voids in the cranial 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

• Patient Contoured Mesh – PEEK (PCM-P) (K072707)

Submission Summary (Full Text)

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

November 9, 2015

KLS Martin L.P. Ms. Jennifer Damato Director of Quality MGT & Regulatory Affairs P.O. Box 16369 Jacksonville, Florida 32245-6369

Re: K151382

Trade/Device Name: Patient Contoured Implant - PEEK (PCI-PEEK) Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: GXN Dated: October 7, 2015 Received: October 8, 2015

Dear Ms. Damato:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S/A

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K151382

#### Device Name

Patient Contoured Implant - PEEK (PCI-PEEK)

Indications for Use (Describe) The Patient Contoured Implant - PEEK (PCI-PEEK) is intended to replace bony voids in the cranial skeleton.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

> Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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## KIST

P.O. Box 16369 · Jacksonville, FL 32245-6369 904-641-7746 or 800-625-1557 • Fax [phone] www.klsmartinnorthamerica.com

#### 510(k) Summary Section 21 CFR 807.92

| Submitter: | KLS-MARTIN L.P. | |
|--------------------|-------------------------------------------------------------------------------------------------------------|--|
| | 11201 Saint Johns Industrial Pkwy S | |
| | Jacksonville, FL 32246 | |
| Contact Person: | Jennifer Damato<br>Director of Quality MGT & Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] | |
| Date Prepared: | November 4, 2015 | |
| Trade Name: | Patient Contoured Implant - PEEK (PCI-PEEK) | |
| Common Name: | Preformed Plate | |
| Classification: | Plate, Cranioplasty, Preformed, Non-alterable<br>Class II, 21 CFR 882.5330, Product Code GXN | |
| Predicate Devices: | Patient Contoured Mesh – PEEK (PCM-P) [K072707] | |
| | No reference devices were used in this submission. | |

#### Device Description:

The Patient Contoured Implant – PEEK (PCI-PEEK) is a preformed implant manufactured from PEEK material. The implant is pre-shaped to fit the anatomy of the patient using a CT-based model of the patient's skull. The PCI-PEEK is fixated to native bone using previously cleared KLS Martin titanium plates and screws.

The purpose of this premarket notification is to offer the implants sterile.

#### Indications for Use:

The Patient Contoured Implant – PEEK (PCI-PEEK) is intended to replace bony voids in the cranial skeleton.

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# KLS martın LP.

## Technological Characteristics / Substantial Equivalence:

| | Patient Contoured Implant – PEEK (PCI-PEEK)<br>(Subject Device) | Patient Contoured Mesh – PEEK (PCM-P)<br>(Predicate: K072707) |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Patient Contoured Implant – PEEK (PCI-PEEK) is intended to replace bony voids in the cranial skeleton. | Patient Contoured Mesh – PEEK (PCM-P) is intended to replace bony voids in the crania and/or craniofacial skeleton. |
| Anatomical Sites | Cranial | Craniomaxillofacial |
| Material | PEEK | PEEK |
| Style | Solid or solid with holes | Solid or solid with holes |
| Sterilization | Provided Sterile (Gamma) | Provided Non-sterile (Steam) |
| Method of Fixation | Titanium Screws and Titanium Plates | Titanium Screws and Titanium Plates |
| Where used (hospital, home, ambulance, etc) | Health Care Facilities / Hospitals | Health Care Facilities / Hospitals |

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Image /page/5/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while "martin" is in gray. The letters "L.P." are in black and are slightly smaller than the other letters in the logo.

#### Performance Data:

#### Biocompatibility Testing

The biocompatibility evaluation for the Patient Contoured Implant - PEEK (PCI-PEEK) was conducted in accordance with the FDA Blue Book Memorandum #G95-1, "Use of International Standard ISO-10993. 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process,' as recognized by FDA.

The patient-contacting material PEEK (Polyether ether ketone) used for the Patient Contoured Implant – PEEK (PCI-PEEK) is previously cleared in K072707. The implant has identical chemical composition, undergoes identical manufacturing processes, and has the same permanent body contact duration as the predicate, K072707.

LAL endotoxin testing demonstrates that the sterile PEEK implant conforms to the required < 2.15 EU/device endotoxin lot release specification.

#### Clinical Studies

Clinical testing was not necessary for the determination of substantial equivalence.

#### Substantial Equivalence Conclusion:

The subject device, Patient Contoured Implant - PEEK (PCI-PEEK), has the same intended use, design, function, and is composed of the same material as the predicate, Patient Contoured Mesh - PEEK (PCM-P). The subject device differs from the predicate in that it will be offered in sterile packaging. The similarities in technological characteristics do not raise new issues of safety or effectiveness and demonstrate substantial equivalence to the predicate device.