PATIENT CONTOURED MESH (PCM)

K062570 · KLS-Martin L.P. · GXN · Oct 31, 2006 · Neurology

Device Facts

• Record ID: K062570
• Device Name: PATIENT CONTOURED MESH (PCM)
• Applicant: KLS-Martin L.P.
• Product Code: GXN · Neurology
• Decision Date: Oct 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Patient Contoured Mesh (PCM) is intended to replace bony voids in mandibular, maxillofacial or craniofacial skeleton.

Device Story

Patient Contoured Mesh (PCM) is a custom-shaped titanium panel; pre-shaped to fit patient anatomy using CT-based models. Device used to replace bony voids in mandibular, maxillofacial, or craniofacial skeleton. Fixated using standard 1.5mm titanium screws. Used by surgeons in clinical settings for reconstructive procedures. Benefits patient by providing patient-specific structural support for skeletal defects.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Custom-shaped CP Titanium panel. Patient-specific geometry derived from CT scan data. Fixation via 1.5mm titanium screws. Non-alterable preformed design.

Indications for Use

Indicated for patients requiring replacement of bony voids in the mandibular, maxillofacial, 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

• Stryker Custom TI Implant (K052871)
• Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) (K053199)
• Synthes (USA) Patient Specific Cranial/Craniofacial Implant (K033868)
• KLS-Martin Micro Osteosynthesis System (1.5 mm) (K944565)
• Centre-Drive Drill Free Screws (DFS) (K971297)

Submission Summary (Full Text)

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# kts martin,L.P.

K662570

## 510(K) SUMMARY

## OCT 3 1 2006

.

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| 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 (PCM) |
| Trade Name: | PCM |
| Common Name: | Titanium Panel |
| Classification Name and Number: | Plate, Cranioplasty, Preformed, Non-Alterable<br>(CFR 882.5330) |
| Regulatory Class: | II |
| Predicate Devices: | Stryker Custom TI Implant (K052871)<br>Synthes Patient Specific Cranial/Craniofacial<br>Implant (PSCI) (K053199)<br>Synthes (USA) Patient Specific<br>Cranial/Craniofacial Implant (K033868)<br>KLS-Martin Micro Osteosynthesis System<br>(1.5 mm) (K944565)<br>Centre-Drive Drill Free Screws (DFS)<br>(K971297) |
| Intended Use: | Patient Contoured Mesh (PCM) is intended to<br>replace bony voids in mandibular, maxillofacial<br>or craniofacial skeleton. |
| Device Description: | Patient Contoured Mesh (PCM) is a custom<br>shaped titanium panel that is pre-shaped to fit<br>the anatomy of the patient using a CT based<br>model of the patient. Patient Contoured Mesh |

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K662570 4/2

(PCM) is fixated using standard KLS Martin's 1.5mm titanium screws (K971297)

### Technological Characteristics:

#### Similarities to Predicate

Patient Contoured Mesh (PCM) and Stryker Custom TI Implant (K052871), 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 titanium.

Patient Contoured Mesh and KLS-Martin Micro Osteosynthesis System (1.5 mm) (K944565) are identical in materials and in the intended use for reconstructive procedures of the mandibular, maxillofacial or craniofacial skeleton.

#### Differences to Predicate

Patient Contoured Mesh (PCM) is manufactured from CP Titanium and Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) (K053199) and Synthes (USA) Patient Specific Cranial/Craniofacial Implant (K033868) are manufactured from titanium and PEEK

#### Substantial Equivalence:

Patient Contoured Mesh (PCM) is substantially equivalent in materials and patient specificity to the Stryker Custom TI Implant (K052871), Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) (K053199) and Synthes (USA) Patient Specific Cranial/Craniofacial Implant (K033868)

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

OCT 3 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

KLS-Martin L.P. % Ms. Jennifer Damato Director RA/QA 11239 St. Johns Industrial Parkway South Jacksonville, Florida 32246

Re: K062570

Trade/Device Name: Patient Contoured Mesh Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: Class II Product Code: GXN Dated: August 18, 2006 Received: August 31, 2006

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 (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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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 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/cdrh/industry/support/index.html.

Sincerely yours

Mark N. Melkerson

Mark N. Melkerson 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

Kd2590

510(k) Number (if known):

Device Name: Patient Contoured Mesh (PCM)

Indications For Use:

Patient Contoured Mesh (PCM) is intended to replace bony voids in mandibular, maxillofacial or craniofacial skeleton.

Prescription Use S (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 IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General, Resto and Neurological Devices | |
| Page 1 of 1 | |
| 510(k) Number | K062570 |

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