OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM

K111176 · Osteomed LP · GWO · Aug 15, 2011 · Neurology

Device Facts

• Record ID: K111176
• Device Name: OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM
• Applicant: Osteomed LP
• Product Code: GWO · Neurology
• Decision Date: Aug 15, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OsteoMed Low Profile Neuro Fixation System is indicated for use in osteotomies, fractures or reconstruction of the cranial bones. The implants and drills are single use only.

Device Story

System comprises low-profile plates (0.25mm-1.0mm), standard screws (1.2mm-1.6mm diameter; 2.0mm-8.0mm length), and Auto-Drive screws (1.2mm-1.6mm diameter; 3.0mm-8.0mm length). Includes manual instrumentation: drill bits, plate bending/holding forceps, cutters, cannulae, taps, countersinks, and screwdrivers. Used by surgeons in clinical settings for cranial bone fixation and reconstruction. Implants provide structural stabilization of bone segments. Device facilitates surgical procedures through mechanical fixation; no software or automated processing involved.

Clinical Evidence

Bench testing only. Verification included mechanical testing and finite element analysis comparing low-profile plates to predicate neuro plates. Biocompatibility confirmed via material consistency with predicate devices. LAL testing performed per ANSI/AAMI ST72:2002. No clinical data required.

Technological Characteristics

Materials: Titanium Alloy (ASTM F-136) for screws; Titanium Alloy (ASTM F-136) or commercially pure Titanium (ASTM F-67) for plates. Instrumentation: surgical grade stainless steel, anodized aluminum, medical grade plastic. Mechanical fixation system. Single-use implants and drills.

Indications for Use

Indicated for patients requiring osteotomies, fractures, or reconstruction of cranial bones.

Regulatory Classification

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.

Predicate Devices

• OsteoMed SBF system (K911936)
• OsteoMed M3 SBF system (K924138)

Submission Summary (Full Text)

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KIIII76

## 510(k) Summary

CG 1 5 2011

Submitter Information:

OsteoMed L. P. 3885 Arapaho Road Addison, Texas 75001 Phone: [phone] Fax: [phone]

Piedad Peña Contact Person:

#### July 27, 2011 Date Prepared:

Device Information:

| Proprietary/Trade Name: | OsteoMed Low Profile Neuro Fixation System |
|-------------------------|--------------------------------------------|
| Common Name: | Low Profile Neuro Plates |

Classification Name:

- · Regulation Number: 21 CFR 882.5320
- · Regulation Name: Preform alterable cranioplasty plate
- · Product Code: GWO, Plate, cranioplasty, preformed, alterable o o GXR. Burr hole cover

Device Class: 2 510(k): K111176

Predicate Devices:

OsteoMed SBF system, K911936 Classification Name: Intraosseous fixation screw or wire (21CFR 872.4880, Product Code DZL) Device Class: 2

OsteoMed M3 SBF system (Addendum), K924138 Classification Name: Bone Plate (21CFR 872.4760, Product Code JEY) Device Class: 2

### Device Description:

The OSTEOMED Low Profile Neuro Fixation System is comprised of plates, screws and instrumentation. The system features plates ranging from 0.25mm to 1.0mm thick, 1.2 mm to 1.6mm diameter standard screws in lengths from 2.0mm to 8.0mm and Auto-Drive screws in 1.2mm to 1.6mm diameters in lengths from 3.0mm to 8.0mm.

OsteoMed L.P. 3885 Arapaho Road Addison, Texas 75001 [phone] FAX: [phone] Customer Service: [phone]

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Image /page/1/Picture/0 description: The image shows the logo for Osteomed. The logo is in black and white and features the word "OSTEOMED" in bold, sans-serif letters. The word is enclosed in a black oval shape. The oval has a thick black outline, and the word "OSTEOMED" is in white.

The instruments include drill bits, plate bending forceps, plate holding forceps, plate cutters, cannulae, taps, countersinks and screwdrivers to facilitate the placement of screws and modification of plates.

The screws are made from Titanium Alloy (ASTM F-136). The plates are made from Titanium Alloy (ASTM F-136) or commercially pure Titanium (ASTM F-67). The instrumentation is made from various grades of surgical grade stainless steel, anodized aluminum, and/or medical grade plastic.

#### Intended Use:

The OsteoMed Low Profile Neuro Fixation System is indicated for use in osteotomies, fractures or reconstruction of the cranial bones. The implants and drills are single use only.

#### Technological Characteristics:

The basis of substantial equivalence for the modification of the OsteoMed SBF system, K911936, is based on the similarities in design, material, function, performance, sterilization, and intended as the predicate device.

#### Performance / Clinical Data:

The low profile neuro plates performed equivalent or with greater strength than the existing neuro predicate devices based on verification testing. Verification consisted of mechanical testing and finite element analysis comparisons against the predicate neuro plates. Limulus Amebocyte Lysate (LAL) testing was conducted in accordance to ANSI/AAMI ST72:2002.

Materials used for the device are the same as the predicate device with changes from CP Ti to Ti-Alloy to maintain equivalent or greater strength to the predicate devices. These materials are biocompatible and already part of the predicate neuro devices.

Clinical Testing was not required for this modification to support substantial equivalence.

#### Conclusion:

The basis of substantial equivalence for the addition of the low profile neuro plates to the current neuro plates of the OsteoMed SBF system, K911936, is based on the similarities in design, material, function, sterilization, and intended use to the predicate device. OsteoMed believes that the modifications do not raise any new safety or effectiveness issues.

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

Osteomed L.P. Mr. Piedad Pena Senior Regulatory Specialist 3885 Arapaho Road Addison, Texas 75001

# AUG 1 5 2011

Re: K111176

Trade/Device Name: OsteoMed Low Profile Neuro Fixation System Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: II Product Code: GWO, GXR Dated: July 27, 2011 Received: July 28, 2011

Dear Mr. Pena:

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.

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Page 2 – Mr. Pena

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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices

Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

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## Indications for Use

510(k) Number (if known):

OSTEOMED Low Profile Neuro Fixation System ___________________________________________________________________________________________________________________________________ Device Name:

Indications for Use:

The OsteoMED Low Profile Neuro Fixation System is indicated for use in osteotomies, fractures or reconstructions of the cranial bones.

Implants and drills are single use only.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: 11176

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