← Product Code [MRW](/productcode/MRW) · K112097

# GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5 (K112097)

_Exactech, Inc. · MRW · Nov 21, 2011 · OR · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K112097

## Device Facts

- **Applicant:** Exactech, Inc.
- **Product Code:** [MRW](/productcode/MRW.md)
- **Decision Date:** Nov 21, 2011
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** OR
- **Attributes:** Therapeutic

## Indications for Use

The Gibralt Spine System Facet Screw is indicated for the posterior surgical treatment at C2- S1 (inclusive) spinal levels for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spondylolysis, fracture, or failed previous fusion.

## Device Story

The Gibralt Spine System Facet Screw is a spinal fixation device used to provide posterior stabilization as an aid to fusion. The device consists of titanium alloy screws implanted via traditional open surgical procedures. It is intended for use by surgeons in a clinical/hospital setting. The system includes a set of manual surgical instruments to assist in implantation. The device functions as a mechanical stabilizer for the spine; it does not involve electronic, software, or algorithmic components. Clinical benefit is derived from providing structural support to the spinal column to facilitate fusion in patients with degenerative or traumatic spinal conditions.

## Clinical Evidence

Bench testing only. No clinical data was provided. Substantial equivalence was established through biomechanical assessment and mechanical testing comparing the device to predicate systems.

## Technological Characteristics

Material: Titanium alloy per ASTM F136. Principle: Mechanical spinal fixation/stabilization. Form factor: Facet screws of various sizes. Sterilization: Non-sterile; requires hospital steam sterilization. Connectivity: None. Software: None.

## Predicate Devices

- TranS1 Facet Screw ([K073515](/device/K073515.md))
- Spartan S3 Facet System ([K092568](/device/K092568.md))
- Corridor Fixation System ([K083442](/device/K083442.md))
- US Spine Facet Fixation System ([K061041](/device/K061041.md))
- DePuy AcroMed Discovery Facet Screw ([K012773](/device/K012773.md))
- SpineFrontier Chameleon Fixation System ([K071420](/device/K071420.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

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

KIL2097

NOV 2 1 2011

## Exactech® Gibralt" Spine System Facet Screw Traditional 510(k)

## 510(k) Summary

| Company:             | Exactech ®, Inc<br>2320 NW 66th Court<br>Gainesville, FL 32653                                       |
|----------------------|------------------------------------------------------------------------------------------------------|
| Date:                | October 5, 2011                                                                                      |
| Contact Person:      | Vladislava Zaitseva<br>Regulatory Affairs Specialist<br>Phone: (352) 377-1140<br>Fax: (352) 378-2617 |
| Proprietary Name:    | Exactech® Gibralt™ Spine System Facet Screw                                                          |
| Common Name:         | Facet screw spinal device                                                                            |
| Classification Name: | Unclassified                                                                                         |
| Product Code:        | MRW                                                                                                  |

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

- TranS1 Facet Screw (K073515) .
- Spartan S3 Facet System (K092568) ●
- Corridor Fixation System (K083442) .
- . US Spine Facet Fixation System (K061041)
- DePuy AcroMed Discovery Facet Screw (K012773)
- SpineFrontier Chameleon Fixation System (K071420) .

#### Device Description

The proposed Gibralt Spine System Facet Screw is a new facet screw device intended to provide posterior fixation as an aid to fusion. The Gibralt Spine System Facet Screw components are available in a variety of sizes and are manufactured from titanium alloy per ASTM F136.

The system components are provided non-sterile. The products must be steam sterilized by the hospital prior to use.

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

#### Indications for Use

The Gibralt Spine System Facet Screw is indicated for posterior surgical treatment at C2-\$1 (inclusive) spinal levels for the following: DDD (neck pain of discogenic origin with

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

# Exactech® Gibralt™ Spine System Facet Screw Traditional 510(k)

- A biomechanical assessment comparing Gibralt Facet Screw mechanical . performance to cited predicate devices.
The results of mechanical testing and analysis demonstrate the proposed device is substantially equivalent to cited predicates.

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

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

NOV 2 1 2011

Exactech, Inc. % Ms. Vladislava Zaitseva 2320 N.W. 66th Court Gainesville, Florida 32653

Rc: K112097

Trade/Device Name: Gibralt Spine Systems Facet Screw Regulatory Class: Unclassified Product Code: MR W Dated: October 05, 2011 Received: October 12, 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 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

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

Page 2 - Ms. Vladislava Zaitseva

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Erin S. Keith

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

Enclosure

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

# Exactech® Gibralt™ Spine System Facet Screw Traditional 510(k)

# Indications for Use Statement

510(k) Number:

KII2097

Device Name: Exactech® Gibralt™ Spine System Facet Screw

#### INDICATIONS FOR USE:

The Gibralt Spine System Facet Screw is indicated for the posterior surgical treatment at C2- S1 (inclusive) spinal levels for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spondylolysis, fracture, or failed previous fusion.

| Prescription Use - X        |  |
|-----------------------------|--|
| (Part 21 CFR 801 Subpart D) |  |

and/or

| 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)

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

K112097 510(k) Number_

---

**Source:** [https://fda-staging.innolitics.com/device/K112097](https://fda-staging.innolitics.com/device/K112097)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com