GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES

K121877 · Exactech, Inc. · KWP · Feb 12, 2013 · Orthopedic

Device Facts

• Record ID: K121877
• Device Name: GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES
• Applicant: Exactech, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Feb 12, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used with the Gibralt System, the Gibralt Occipital Spine System is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput -T3). The Gibralt Occipital Spine System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/dislocation, occipital-cervical dislocation, atlanto-axial fracture with instability, failed previous fusion and/or tumors. The Occipital Bone Screws are limited to occipital fixation only. The use of polyaxial screws is limited to placement in TI-T3 in treating thoracic conditions only. Polyaxial screws are not intended to be placed in the cervical spine.

Device Story

Posterior spinal fixation system providing immobilization and stabilization as an adjunct to fusion. Components include occipital plates, occipital bone screws, articulating rods, and set screws; used with Gibralt Spine System (hooks, polyaxial screws). Implanted via traditional open surgical procedure by surgeons. System provides mechanical stability to spinal segments. Benefits include stabilization of the occipital-cervical-thoracic region to promote fusion in patients with degenerative or traumatic spinal conditions.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical testing included static compression bend, dynamic compression bend, static yield torsion, dynamic torsion, and axial pullout testing per ASTM F2706 and ASTM F543 standards.

Technological Characteristics

Components manufactured from titanium alloy per ASTM F136. System includes occipital plates, bone screws, articulating rods, and set screws. Non-sterile, single-use, steam-sterilized by hospital. Mechanical performance validated per ASTM F2706 and ASTM F543. No software or electronic components.

Indications for Use

Indicated for patients requiring spinal fusion in the cervical spine and occipito-cervico-thoracic junction (occiput-T3) due to DDD, spondylolisthesis, spinal stenosis, fracture/dislocation, occipital-cervical dislocation, atlanto-axial fracture with instability, failed fusion, or tumors. Occipital bone screws restricted to occipital fixation; polyaxial screws restricted to T1-T3 thoracic conditions.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• DePuy Mountaineer OCT Spinal System (K110353, K042508, and K041203)
• Medtronic Vertex Select Reconstruction System (K110522, K091365, K090714, and K082728)
• Zimmer (Abbott Spine) Nex-Link OCT Cervical Plating System (K090060)

Submission Summary (Full Text)

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#### 510(k) Summary

### FEB 1 2 2013

| Company: | Exactech®, Inc<br>2320 NW 66th Court<br>Gainesville, FL 32653 |
|----------------------|---------------------------------------------------------------|
| Date: | January 14, 2013 |
| Contact Person: | Vladislava Zaitseva<br>Sr. Regulatory Affairs Specialist |
| | Phone: [phone]<br>Fax: [phone] |
| Proprietary Name: | Exactech® Gibralt® Occipital Spine System |
| Common Name: | Occipital Plate System |
| Classification Name: | Appliance, fixation, spinal interlaminal |
| Product Code: | KWP |

#### Legally Marketed Devices to Which Substantial Equivalence Is Claimed

- DePuy Mountaineer OCT Spinal System (K110353, K042508, and K041203) .
- t Medtronic Vertex Select Reconstruction System (K110522, K091365, K090714, and K082728)
- Zimmer (Abbott Spine) Nex-Link OCT Cervical Plating System (K090060) .

#### Device Description

The Gibralt Occipital Spine System is a new posterior system intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the occipital-cervical-thoracic region of the spine.

The system consists of a variety of sizes of the occipital plates and occipital bone screws, and articulating rod and set screws. All components of the system are manufactured from titanium allov per ASTM F136.

The Gibralt Occipital system should be used in conjunction with the Gibralt Spine System components such as hooks, polyaxial screws and connecting components. The Gibralt Spine System has been cleared by FDA through 510(k) # K 110197 on July 15, 2011.

The Gibralt Occipital Spine System is provided with a complete instrumentation system to assist the surgeon in the implantation of the components according to a traditional open surgical procedure.

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#### Indications for Use

When used with the Gibralt Spine System, the Gibralt Occipital Spine System is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput -T3). The Gibralt Occipital Spine System is indicated for the following: DDD (neck pain of discogenic origin with deveneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/dislocation, occipital-cervical dislocation, atlanto-axial fracture with instability, failed previous fusion and/or tumors.

The Occipital Bone Screws are limited to occipital fixation only.

The use of polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. Polyaxial screws are not intended to be placed in the cervical spine.

#### Summary of Technological Characteristics

The rationale for substantial equivalence is based on consideration of the following characteristics:

- Intended Use/Indications for Use . The proposed Gibralt Occipital Spine System and predicates have similar indications for use statements.
- . Materials

The proposed Gibralt Occipital Spine System components and predicate devices are composed of titanium allov, a biocompatible material conforming to a recognized industry standard for permanent implants.

#### . Design Features

The proposed Gibralt Occipital Spine System components and predicate devices have similar design features.

- • Dimensions
The proposed Gibralt Occipital Spine System components and predicate devices are dimensionally comparable.

#### . Packaging and Sterilization

The proposed Gibralt Occipital Spine System components and predicate devices are provided non-sterile for single use only, and will be steam sterilized by the hospital prior to use in the operating room using the same sterilization method.

- . Device Shelf Life
Neither the Gibralt Occipital Spine System components nor cited predicate devices have shelf life expiration dating.

- . Performance specifications The Gibralt Occipital Spine System and cited predicates all withstand clinically relevant biomechanical loads.

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#### Substantial Equivalence Conclusion

The following mechanical testing and engineering analyses were conducted to demonstrate substantial equivalence of the proposed Gibralt Occipital Spine System to cited predicates:

- Static Compression Bend, Dynamic Compression Bend, Static Yield Torsion, . Dynamic Torsion, Axial Pullout and Static Torque testing per ASTM F2706 and ASTM F543.
- A biomechanical assessment comparing Gibralt Occipital Spine System . mechanical performance and design features to cited predicate devices.

The results of mechanical testing and analysis demonstrate the proposed device is substantially equivalent to cited predicates.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings outstretched, symbolizing protection and care.

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

#### Letter dated: February 12, 2013

Exactech®, Incorporated % Travis Arola, MS, RAC, CTBS Director, Regulatory, Spine & Biologics 2320 Northwest 66th Court Gainesville, Florida 32653

Re: K121877

Trade/Device Name: Exactech® Gibralt® Occipital Spine System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: January 14, 2013 Received: January 16, 2013

Dear Mr. Arola:

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. Iisting 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 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.

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#### Page 2 - Travis Arola, MS, RAC, CTBS

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.

## Mark Melkerson

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use Statement

K121877 510(k) Number:

Device Name: Exactech® Gibralt® Occipital Spine System

#### INDICATIONS FOR USE:

When used with the Gibralt System, the Gibralt Occipital Spine System is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput -T3). The Gibralt Occipital Spine System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/dislocation, occipital-cervical dislocation, atlanto-axial fracture with instability, failed previous fusion and/or tumors.

The Occipital Bone Screws are limited to occipital fixation only.

The use of polyaxial screws is limited to placement in TI-T3 in treating thoracic conditions only. Polyaxial screws are not intended to be placed in the cervical spine.

Over-The-Counter Use Prescription Use X and/or (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

Please do not write below this line - use another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Ronald PaJean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K121877