PATIENT CONTOURED MESH-PEEK (PCM-P)

K072707 · KLS-Martin L.P. · GXN · Dec 19, 2007 · Neurology

Device Facts

• Record ID: K072707
• Device Name: PATIENT CONTOURED MESH-PEEK (PCM-P)
• Applicant: KLS-Martin L.P.
• Product Code: GXN · Neurology
• Decision Date: Dec 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Patient Contoured Mesh – PEEK (PCM-P) is intended to replace bony voids in the cranial and/or craniofacial skeleton

Device Story

Patient Contoured Mesh – PEEK (PCM-P) is a custom-shaped PEEK (polyetheretherketone) panel designed to fit specific patient anatomy. The device is manufactured based on a CT-derived model of the patient's cranial or craniofacial defect. It is intended for use as a preformed, non-alterable cranioplasty plate to replace bony voids. The implant is secured to the patient using standard KLS Martin titanium plates and screws (1.0mm to 2.3mm). The device is intended for prescription use by clinicians to restore skeletal structure in the cranial or craniofacial region.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Custom-shaped PEEK (polyetheretherketone) panel. Preformed to patient anatomy via CT-based modeling. Fixation via titanium plates and screws (1.0mm–2.3mm).

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

• Patient Contoured Mesh (PCM) (K062570)
• Stryker Patient Specific Polymer Implant (K043250)
• Stryker Custom TI Implant (K052871)
• Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) (K053199)
• Synthes (USA) Patient Specific Cranial/Craniofacial Implant (K033868)

Submission Summary (Full Text)

{0}------------------------------------------------

07270) pge 142

# kls martin LP.

| DEC 1 9 2007 | | |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 510(K) SUMMARY | | |
| Submitter: | KLS-Martin, L.P.<br>11239-1 St. Johns Industrial Parkway South<br>Jacksonville, FL 32246<br>Phone: [phone]<br>Fax: [phone] | |
| Contact Person: | Jennifer Damato<br>Director RA/QA | |
| Date of Summary: | 18 August 2006 | |
| Device Name: | Patient Contoured Mesh – PEEK (PCM-P) | |
| Trade Name: | PCM - P | |
| Common Name: | Preformed Plate | |
| Classification<br>Name and Number: | Plate, Cranioplasty, Preformed, Non-Alterable<br>(CFR 882.5330) | |
| Regulatory Class: | II | |
| Predicate Devices: | Patient Contoured Mesh (PCM) (K062570)<br>Stryker Patient Specific Polymer Implant (K043250)<br>Stryker Custom TI Implant (K052871)<br>Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) (K053199)<br>Synthes (USA) Patient Specific<br>Cranial/Craniofacial Implant (K033868) | |
| Intended Use: | Patient Contoured Mesh – PEEK (PCM-P) is<br>intended to replace bony voids in the cranial<br>and/or craniofacial skeleton | |

{1}------------------------------------------------

page 2 of 2

Device Description:

Patient Contoured Mesh - PEEK (PCM-P) is a custom shaped PEEK panel that is pre-shaped to fit the anatomy of the patient using a CT based model of the patient. Patient Contoured Mesh - PEEK (PCM-P) is fixated using standard KLS Martin's titanium plates and screws in sizes 1.0mm through 2.3mm

### Technological Characteristics:

## Similarities to Predicate

Patient Contoured Mesh - PEEK (PCM-P), Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) (K053199) and Synthes (USA) Patient Specific Cranial/Craniofacial Implant (K033868) are patient specific implants that are manufactured from PEEK.

#### Differences to Predicate

Patient Contoured Mesh - PEEK (PCM-P) is manufactured from PEEK, the previously cleared Patient Contoured Mesh (PCM) (K062570) is manufactured from titanium and Stryker Patient Specific Polymer Implant (K043250) is manufactured from surgical simplex P radiopaque bone cement.

#### Substantial Equivalence:

Patient Contoured Mesh - PEEK (PCM-P) is substantially equivalent in intended use and patient specificity to the Patient Contoured Mesh (PCM) (K062570), Stryker Patient Specific Polymer Implant (K043250), Stryker Custom Ti Implant (K052871), Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) (K053199) and Synthes (USA) Patient Specific Cranial/Craniofacial Implant (K033868)

{2}------------------------------------------------

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 stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2007

KLS-Martin, L.P. % Ms. Jennifer Damato Director RAQA 11239-1 St. Johns Industrial Parkway South Jacksonville, FL 32246

K072707 Re:

> Trade/Device Name: Patient Contoured Mesh -PEEK (PCM-P) Regulation Number: 21 CFR 882.5330 Regulation Name: Performed non-alterable cranioplasty plate Regulatory Class: Class II Product Code: GXN, GXP Dated: November 16, 2007 Received: November 19, 2007

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.

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

#### Page 2 - Ms. Jennifer Damato

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Wilkinson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known):

Device Name: Patient Contoured Mesh - PEEK (PCM-P)

Indications For Use:

Patient Contoured Mesh - PEEK (PCM-P) is intended to replace bony voids in the cranial and/or craniofacial skeleton

V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

No Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Салвае вожело

(Division Sign Division of General, Restorative, and Neurological Devices

Page 1 of 1

**510(k) Number** K022707