SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM

K132740 · Spinefrontier, Inc. · NQW · Nov 26, 2013 · Orthopedic

Device Facts

• Record ID: K132740
• Device Name: SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM
• Applicant: Spinefrontier, Inc.
• Product Code: NQW · Orthopedic
• Decision Date: Nov 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LESPlasty™ Posterior Cervical Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The system is used to hold or buttress the allograft or autograft material in place in order to prevent the allograft or autograft material from expelling or impinging the spinal cord.

Device Story

SpineFrontier® LESPlasty™ System is a posterior cervical laminoplasty fixation system consisting of titanium alloy (ASTM F136) plates and screws. Used by surgeons in clinical settings to stabilize the spine during laminoplasty procedures. Plates feature screw holes for attachment to the lamina and lateral mass; primary and recovery bone screws provide fixation. The system functions as a mechanical buttress to hold allograft or autograft material in place, preventing graft expulsion or spinal cord impingement. Device performance is validated through static and dynamic mechanical testing.

Clinical Evidence

Bench testing only. Testing included static axial pullout (ASTM F-543) and static/dynamic four-point bending (ASTM F-2193). Results confirm mechanical strength is sufficient for intended use and comparable to predicate devices.

Technological Characteristics

Components fabricated from medical grade titanium alloy (ASTM F136). System includes plates and screws for posterior cervical/thoracic fixation. Mechanical testing performed per ASTM F-543 and ASTM F-2193. No software or electronic components.

Indications for Use

Indicated for patients undergoing laminoplasty procedures in the lower cervical and upper thoracic spine (C3 to T3) to secure allograft or autograft material.

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

• Synthes Arch™ Fixation System (AFS) (K032534)
• MedtronicCenterpiece™ Plate Fixation System (K050082)

Submission Summary (Full Text)

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

| Submitter's Name: | SpineFrontier, Inc. |
|-------------------------------|-----------------------------------------------------------------------------------------------------------|
| Submitter's Address: | 500 Cummings Center, Suite 3500<br>Beverly, MA 01915, U.S.A. |
| Submitter's Telephone: | 978.232.3990 x116 |
| Contact Person: | Paul L. Speidel<br>Regulatory Affairs Manager<br>Tel: [phone]<br>Fax: [phone] |
| Prepared by: | Meredith L. May, MS<br>Empirical Testing Corp.<br>719.337.7579 |
| Date Summary was<br>Prepared: | August 30th, 2013 |
| Trade or Proprietary Name: | SpineFrontier® LESPlasty™ Posterior Cervical<br>Laminoplasty System |
| Common or Usual Name: | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Classification: | Class II per 21 CFR §888.3050 |
| Product Code: | NQW |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Predicate Devices: | Synthes Arch™ Fixation System (AFS) (K032534)<br>MedtronicCenterpiece™ Plate Fixation System<br>(K050082) |

# 5.510(K) SUMMARY

## DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The SpineFrontier® LESPlasty™ System consists of various sized plates and screws designed for a systematic posterior approach to cervical laminoplasty procedures. The plates have screw holes which allow for attachment to the lamina and the lateral mass. The system is provided with primary and recovery bone screws for fixation. Plates and screws are fabricated from medical grade titanium alloy (ASTM F136).

## INDICATIONS FOR USE

The LESPlasty™ Posterior Cervical Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The system is used to

SpineFrontier® LESPlasty™ Posterior Cervical Laminoplasty System

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

hold or buttress the allograft or autograft material in place in order to prevent the allograft or autograft material from expelling or impinging the spinal cord.

The indication for use for the SpineFrontier® LESPlasty™ System is similar to that of the Synthes Arch™ Fixation System (AFS) (K032534) and MedtronicCenterpiece™ Plate Fixation System (K050082).

### TECHNICAL CHARACTERISTICS

All components are fabricated from medical grade titanium alloy (ASTM F136). Titanium alloys have a successful history of use in the spinal implant industry and use of it in these devices does not introduce any previously unaccepted patient risks. The Synthes Arch™ Fixation System (AFS) (K032534) and MedtronicCenterpiece™ Plate Fixation System (K050082) are manufactured from titanium or titanium alloy.

### PERFORMANCE DATA

The LESPlasty™ Posterior Cervical Laminoplasty System has been tested in the following test modes:

- . Static Axial Pullout (ASTM F-543)
- Static Four-Point Bending (ASTM F-2193) .
- Dynamic Four-Point Bending (ASTM F-2193) o

The results of this non-clinical testing show that the strength of the LESPlasty™ System is sufficient for its intended use and legally marketed predicate devices.

#### CONCLUSION

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

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

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

SpineFrontier, Incorporated . % Empirical Testing Corporation Meredith May, MS, RAC 4628 Northpark Drive Colorado Springs, Colorado 80918 November 26, 2013

Re: K132740

Trade/Device Name: SpineFrontier® LESPlasty™ Posterior Cervical Laminoplasty System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NQW Dated: November 21, 2013 Received: November 25, 2013

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. 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

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

#### Page 2 - Mr. Justin Eggleton

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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/McdicalDevices/ResourcesforYou/Industry/default.htm. Also. please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/McdicalDevices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark Nielkerson -S

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

Enclosure

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

| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: December 31, 2013<br>See PRA Statement on last page. |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Indications for Use | |

| 510(k) Number (if known) | K132740 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| DEVICE NAME | |
| SpineFrontier® LESPlasty™ Posterior Cervical Laminoplasty System<br>Indications for Use (Describe) | |
| The LESPlasty™ Posterior Cervical Laminoplasty System is intended for use in the lower cervical and upper<br>thoracic spine (C3 to T3) in laminoplasty procedures. The system is used to hold or buttress the allograft or<br>autograft material in place in order to prevent the allograft or autograft material from expelling or impinging<br>the spinal cord. | |

| TYPE OF USE (SELECT ONE OR BOTH, AS APPLICABLE) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">✔</span> Prescription Use (Part 21 CFR 801 Subpart D) <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
| PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. |
| FOR FDA USE ONLY |
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) |
| Ronald P. Jean -S |

.

-

SpineFrontier® LESPlasty™ Posterior Cervical Laminoplasty System