R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM

K032752 · R&B Surgical Solutions, LLC · KWQ · Dec 3, 2003 · Orthopedic

Device Facts

• Record ID: K032752
• Device Name: R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM
• Applicant: R&B Surgical Solutions, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Dec 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The R&B Surgical Solutions SmartPlate™ Cervical Plate System is intended for anterior screw fixation of the cervical spine and is designed to provide stabilization as an adjunct to spinal fusion at these levels. Indications for the use of this device include failed previous fusion, pseudarthrosis, tumor, deformity, spinal stenosis, trauma, spondylolisthesis or degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. WARNING: The R&B Surgical Solutions SmartPlate™ Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Device Story

SmartPlate™ Cervical Plate System provides anterior spinal stabilization as an adjunct to cervical fusion. System comprises titanium alloy plates, screws, and screw-retaining covers. Used by surgeons in clinical settings to stabilize cervical spine segments. Device components are implanted to provide mechanical support during the fusion process. Benefits include stabilization of the cervical spine in patients with degenerative conditions, trauma, or deformity.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Components manufactured from titanium alloy (ASTM F136). System includes plates, screws, and screw-retaining covers. Mechanical fixation device.

Indications for Use

Indicated for anterior cervical spine screw fixation as an adjunct to fusion in patients with degenerative disc disease (discogenic neck pain confirmed by history/radiography), spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis, or failed previous fusion. Contraindicated for posterior element (pedicle) fixation in cervical, thoracic, or lumbar spine.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Submission Summary (Full Text)

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

K032752

1-41

DEC = 3 2003

## Attachment VIII 510(k) Summary

| Sponsor: | R&B Surgical Solutions, LLC<br>2530 Superior Ave., Suite 703<br>Cleveland, OH 44114 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact<br>Person: | James M. Moran, Vice President of Engineering and Chief Technical Officer |
| Proprietary<br>Trade Name: | R&B Surgical Solutions SmartPlate™ Cervical Plate System |
| Device<br>Description: | The R&B Surgical Solutions SmartPlate™ Cervical Plate System consists of<br>plates, screws and screw-retaining covers. The device, as a system, is designed to<br>provide stabilization as an adjunct to cervical fusion. |
| Intended Use: | The R&B Surgical Solutions SmartPlate™ Cervical Plate System is intended for<br>anterior screw fixation of the cervical spine and is designed to provide<br>stabilization as an adjunct to spinal fusion at these levels. Indications for the<br>use of this device include failed previous fusion, pseudarthrosis, tumor,<br>deformity, spinal stenosis, trauma, spondylolisthesis or degenerative disc<br>disease defined as neck pain of discogenic origin with the degeneration of the<br>disc confirmed by history and radiographic studies.<br><br>WARNING: The R&B Surgical Solutions SmartPlate™ Cervical Plate System is<br>not intended for screw attachment or fixation to the posterior elements (pedicles)<br>of the cervical, thoracic or lumbar spine. |
| Materials: | The SmartPlate™ Cervical Plate System components are manufactured from<br>titanium alloy (ASTM F136). |
| Substantial<br>Equivalence: | Documentation was provided which demonstrated the SmartPlate™ Cervical<br>Plate System to be substantially equivalent to previously cleared devices. The<br>substantial equivalence is based upon equivalence in indications for use,<br>anatomic sites, performance and material of manufacture. |

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

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 3 2003

R&B Surgical Solutions, LLC C/o Ms. Karen E. Warden, MEBE KWERC 8202 Sherman Road Chesterland, Ohio 44026

Re: K032752

K032732
Trade/Device Name: SmartPlate™ Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: September 5, 2003 Received: September 5, 2003

Dear Ms. Warden:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section > for(x) premainer is substantially equivalent (for the indications
referenced above and have determined the device is substanted in interstate referenced above and nave decemblicate devices marketed predicate devices marketed in interstate for use stated in the enclosury manoted provinces provide increating of the Rederal Food. Drug commerce prior to May 28, 1970, the chance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provision onlinestion (PM devices that have been reclassified in accenance whiles approval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . and Cosmetic Act (Act) that do not require approvate of the general controls of the Act. The You may, mercede, market the Act include requirements for annual registration. Insting of general controls provisions of the Fielding, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) moved in the major regulations affecting your device can
may be subject to such additional controls. Title of to 900 to 908 - In add may be subject to such additional controlior Links. John 800 to 898. In addition, FDA may be found in the Ood or I sates oncerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issumos of a backed in a problem with other requirements of the Act that FDA has made a determination an a Jecinistered by other Federal agencies. You must of any Federal Statutes and regulations and linited to: registration and listing (21) CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requiremts as see CFR Part 807), adomig (21 CFR Part 820), and if applicable, the electronic forth in the quality systems (QD) regalativ (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 - Ms. Karen Warden

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lower with and in yours of substantial equivalence of your device to a legally prematicated predicated wice 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 If you don't opportio arrivaliance at [phone]. Also, please note the regulation entitled, oonwood in Office of Court to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Mula M. Millerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure ·

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

K032752

lsll

## Indications for Use Attachment III

510(k) Number:

Device Name: SmartPlate™ Cervical Plate System

Indications for Use:

The R&B Surgical Solutions SmartPlate™ Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.

WARNING: The R&B Surgical Solutions SmartPlate™ Cervical Plate System is not intended for WHITH OF Tixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

for Mark A. Milkers

K032752

Perforative

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prcscription Use \$\surd\$
(21 CFR 801.109)

ાર

()ver-the-Counter Use_

(Per 21 CFR 801.109)