EXACTECH GIBRALT SPINAL SYSTEM

K110197 · Exactech, Inc. · MNI · Jul 15, 2011 · Orthopedic

Device Facts

• Record ID: K110197
• Device Name: EXACTECH GIBRALT SPINAL SYSTEM
• Applicant: Exactech, Inc.
• Product Code: MNI · Orthopedic
• Decision Date: Jul 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal 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, failed previous fusion and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C3-T3) spine. 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. This system can be used independently or in conjunction with Exactech 5.5mm or 6.0mm rod-based Thoraco-Lumbar Pedicle Screw Systems.

Device Story

Top-loading spinal fixation system; components include polyaxial screws, rods, hooks, and connectors. Used for immobilization and stabilization of spinal segments as an adjunct to fusion. Operated by surgeons in an open surgical procedure. Components provided non-sterile; require hospital steam sterilization. System provides mechanical support to promote fusion in cervical/upper thoracic spine (C3-T3). Can be used independently or with existing rod-based systems.

Clinical Evidence

Bench testing only. Mechanical performance validated via static compression bending, static torsion, and dynamic compression bending per ASTM F1717, and rod-to-rod connector flexural/torsion grip testing per ASTM F1798. Biomechanical assessment confirmed performance equivalence to predicate devices.

Technological Characteristics

Titanium alloy (ASTM F136) components. Top-loading polyaxial screw, rod, and hook design. Non-sterile, single-use, steam-sterilizable. Mechanical fixation system; no software or electronic components.

Indications for Use

Indicated for patients requiring spinal fusion or stabilization in the cervical and upper thoracic spine (C3-T3) due to DDD, spondylolisthesis, spinal stenosis, fracture, dislocation, failed fusion, or tumors. Polyaxial screws restricted to T1-T3 thoracic use; contraindicated for cervical spine placement.

Regulatory Classification

Identification

(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.

Special Controls

*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.” (2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

Predicate Devices

• S4 Spinal System (K050979)
• Vertex Reconstruction System (K003780)
• CerviFix Axon System (K991089/K023675)

Submission Summary (Full Text)

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K110197

## 510(k) Summary

JUL 15 2011

| Company: | Exactech ®, Inc<br>2320 NW 66th Court<br>Gainesville, FL 32653 |
|-----------------|----------------------------------------------------------------|
| Date: | January 21, 2011 |
| Contact Person: | Vladislava Zaitseva |

Contact Person:

Regulatory Affairs Specialist Phone: [phone] Fax: [phone]

Exactech® Gibralt™ Spinal System Proprietary Name:

Common Name: Spinal Fixation System

### Classification Name:

- 21 CFR 888.3070 Pedicle screw spinal system, Class II, Product Code: MNI -. Orthosis, Spinal Pedicle Fixation
- 21 CFR 888.3050 Spinal interlaminal fixation orthosis, Class II, Product Code: . KWP - appliance, fixation, spinal interlaminal

## Legally Marketed Devices to Which Substantial Equivalence Is Claimed

- S4 Spinal System (K050979) ●
- Vertex Reconstruction System (K003780) .
- CerviFix Axon System (K991089/K023675) .

## Device Description

This submission proposes a new spinal fixation system. The proposed Gibralt Spinal System is a top-loading spinal fixation system that comprises various sizes of polyaxial screws, rods, hooks, and various connectors to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the cervical, and/or upper thoracic spine. The Gibralt Spinal System components are manufactured from titanium alloy per ASTM F136. The system components are provided clean and non-sterile. The products must be steam sterilized by the hospital prior to use.

The Gibralt Spinal System includes a complete instrumentation system to assist the surgeon in the implantation of each component according to a traditional open surgical procedure.

### Indications for Use

When intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),

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K 110197

spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C3-T3) spine.

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.

This system can be used independently or in conjunction with Exactech 5.5mm or 6.0mm rod-based Thoraco-Lumbar Pedicle Screw Systems.

### Summary of Technological Characteristics

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

#### . Intended Use/Indications for Use.

The Gibralt Spinal System has the equivalent indications for use and intended uses as the sited predicates.

#### Materials .

The Gibralt Spinal System and predicates are composed of titanium alloy, a biocompatible material conforming to a recognized industry standard for permanent implants.

#### . Design Features

The Gibralt Spinal System and predicates have similar design features.

#### . Dimensions

The Gibralt Spinal System and predicates are dimensionally comparable.

#### . Packaging and Sterilization

The Gibralt Spinal System and predicates 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 method.

#### Device Shelf Life .

Neither the Gibralt Spinal System nor cited predicates have shelf life expiration dating.

#### Performance specifications .

The Gibralt Spinal System and cited predicates all withstand clinically relevant biomechanical loads.

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K110197

### Substantial Equivalence Conclusion

The following mechanical testing and engineering analysis were conducted to demonstrate substantial equivalence of the proposed Gibralt Spinal System to the predicates:

- Rod-to-rod connector Flexural Grip and Torsion Grip testing in accordance with . ASTM F1798.
- . Static Compression Bending, Static Torsion, and Dynamic Compression bending testing in accordance with ASTM F1717.
- A biomechanical assessment comparing Gibralt Spinal System mechanical . performance to cited predicate devices.

The results of mechanical testing and analysis demonstrate that the proposed devices are substantially equivalent to cited predicates.

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

Exactech, Inc. % Ms. Vladislava Zaitseva Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653

JUL 15 2011

Re: K110197

Trade/Device Name: Exactech® Gibralt™ Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, KWP Dated: June 15, 2011 Received: June 16, 2011

Dear Ms. Zaitseva:

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

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Page 2 – Ms. Vladislava Zaitseva

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 (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.

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/ReportalProblem/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 vours

Sincerely yours,

Euid Keith

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

Enclosure

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# Indications for Use Statement

K110197 510(k) Number:

Device Name: Exactech® Gibralt™ Spinal System

## INDICATIONS FOR USE:

When intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal 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, failed previous fusion and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C3-T3) spine.

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.

This system can be used independently or in conjunction with Exactech 5.5mm or 6.0mm rod-based Thoraco-Lumbar Pedicle Screw Systems.

Prescription Use X and/or (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (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)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KI10197 510(k) Number.