RESOLUTE FACET SCREW SYSTEM

K121551 · Neurostructures, LLC · MRW · Oct 23, 2012 · OR

Device Facts

• Record ID: K121551
• Device Name: RESOLUTE FACET SCREW SYSTEM
• Applicant: Neurostructures, LLC
• Product Code: MRW · OR
• Decision Date: Oct 23, 2012
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Resolute Facet Screw System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The device is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: Spondylolisthesis, Pseudoarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.

Device Story

Resolute Facet Screw System provides bilateral transfacet fixation for lumbar spine stabilization. System consists of single-use, non-sterile, cannulated titanium alloy screws in fully or partially threaded designs. Used by surgeons in posterior spinal procedures to aid fusion at L1-S1 levels. Device functions as mechanical fixation hardware; no software or electronic components. Clinical benefit derived from stabilizing spinal segments in patients with degenerative conditions or failed prior fusions.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by cantilever testing and engineering analysis.

Technological Characteristics

Titanium alloy (6AL-4v-ELI per ASTM F136). Cannulated, single-use, non-sterile screws. Fully and partially threaded designs. Mechanical fixation device; no energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring posterior spinal stabilization as an aid to fusion at L1-S1 levels. Conditions include symptomatic spondylolisthesis, pseudoarthrosis, failed previous fusions, and degenerative disc disease (DDD) with discogenic pain or facet instability.

Predicate Devices

• Spineology® Capture™ Facet Screw System (K092464)
• NuVasive® Triad® Facet Screw System (K020411)

Submission Summary (Full Text)

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# 5. 510(k) Summary

OCT 2 3 2012

Image /page/0/Picture/3 description: The image shows the logo for Neurostructures. The logo consists of a square divided into four smaller squares, with the top left square being solid black and the other three squares being grayscale. To the right of the square is the word "NEURO" in large, bold, sans-serif font, with the letters slightly spaced apart. Below "NEURO" is the word "STRUCTURES" in a smaller, sans-serif font, and above the "O" in "NEURO" is the trademark symbol.

| Submitter's Name: | NeuroStructures |
|----------------------------|----------------------------------------------------------------------------------------------------|
| Submitter's Address: | 63 Bovet Road, Suite 135<br>San Mateo, CA 94402 |
| Submitter's Telephone: | 800-352-6103 |
| Contact Name: | John Stephani |
| Date Summary was Prepared: | 18 May 2012 |
| Trade or Proprietary Name: | Resolute™ Facet Screw System |
| Common or Usual Name: | Screw, Fixation, Bone |
| Classification: | Unclassified |
| Product Codes: | MRW |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Predicate Device: | Spineology® Capture™ Facet Screw System (K092464)<br>NuVasive® Triad® Facet Screw System (K020411) |

#### Description of the Device Subject to Premarket Notification:

The Resolute Facet Screw System is comprised of various sized single-use, non-sterile facet screws that are designed to provide bilateral transfacet fixation of the lumbar facet joints. The system consists of titanium alloy (6AL-4v-EU per ASTM F136) screws in fully threaded and partially threaded designs, both of which are cannulated.

#### INDICATIONS FOR USE

The Resolute Facet Screw System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The device is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: Spondylolisthesis, Pseudoarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.

Resolute Facet Screw System

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## Technical Characteristics

The Resolute Facet Screw System screws are manufactured from titanium alloy (6AL-4v-ELI per ASTM F136), similar to the referenced predicate devices. No new technical characteristics are being introduced with this product.

## Performance Data

Cantilever testing and engineering analysis was completed on the Resolute Facet Screw System.

#### Conclusion

The overall technology characteristics and mechanical performance data lead to the conclusion that Resolute Facet Screw System is substantially equivalent to the predicate devices.

Resolute Facet Screw System

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings outstretched, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right. The logo is simple and recognizable.

#### Public Health Service

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

Neurostructures, LLC % Empirical Testing Corporation Ms. Meredith May, MS 4628 Northpark Drive Colorado Spring, Colorado 80918

Re: K121551

Trade/Device Name: Resolute Facet Screw System Regulatory Class: Unclassified Product Code: MRW Dated: September 06, 2012 Received: October 15, 2012

Dear Ms. May:

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.

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

OCT 23 2012

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Page 2 – Ms. Meredith May, MS

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 vours,

for
Melkerson

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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K121551

# 4. Indications for Use Statement

Device Name: Resolute Facet Screw System

The Resolute Facet Screw System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The device is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: Spondylolisthesis, Pseudoarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.

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)

(Divisi Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

KIZISSI 510(k) Number_

Resolute Facet Screw System