K Number
K032752
Device Name
R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM
Date Cleared
2003-12-03

(89 days)

Product Code
Regulation Number
888.3060
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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.
Device Description
The R&B Surgical Solutions SmartPlate™ Cervical Plate System consists of plates, screws and screw-retaining covers. The device, as a system, is designed to provide stabilization as an adjunct to cervical fusion.
More Information

Not Found

Not Found

No
The 510(k) summary describes a mechanical implant (plates, screws, and covers) for spinal fusion and does not mention any software, algorithms, or AI/ML capabilities.

Yes
The device is described as providing stabilization as an adjunct to spinal fusion for various medical conditions, including tumor, deformity, spinal stenosis, trauma, and degenerative disc disease, which are therapeutic interventions.

No
Explanation: The device is a surgical implant (cervical plate system) used for stabilization during spinal fusion, not for diagnosing medical conditions. Its indications for use describe conditions it helps treat, not conditions it diagnoses.

No

The device description explicitly states it consists of "plates, screws and screw-retaining covers," which are physical hardware components.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device description: The R&B Surgical Solutions SmartPlate™ Cervical Plate System is a physical implantable device (plates, screws, and covers) used for surgical fixation of the cervical spine.
  • Intended Use: The intended use is for surgical stabilization as an adjunct to spinal fusion, not for testing biological samples.

The device is a surgical implant, not a diagnostic test.

N/A

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

KWQ

Device Description

The R&B Surgical Solutions SmartPlate™ Cervical Plate System consists of plates, screws and screw-retaining covers. The device, as a system, is designed to provide stabilization as an adjunct to cervical fusion.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

cervical spine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
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.(b)
Classification. Class II.

0

K032752

1-41

DEC = 3 2003

Attachment VIII 510(k) Summary

| Sponsor: | R&B Surgical Solutions, LLC
2530 Superior Ave., Suite 703
Cleveland, OH 44114 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact
Person: | James M. Moran, Vice President of Engineering and Chief Technical Officer |
| Proprietary
Trade Name: | R&B Surgical Solutions SmartPlate™ Cervical Plate System |
| Device
Description: | The R&B Surgical Solutions SmartPlate™ Cervical Plate System consists of
plates, screws and screw-retaining covers. The device, as a system, is designed to
provide stabilization as an adjunct to cervical fusion. |
| 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. |
| Materials: | The SmartPlate™ Cervical Plate System components are manufactured from
titanium alloy (ASTM F136). |
| Substantial
Equivalence: | Documentation was provided which demonstrated the SmartPlate™ Cervical
Plate System to be substantially equivalent to previously cleared devices. The
substantial equivalence is based upon equivalence in indications for use,
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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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)

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()ver-the-Counter Use_

(Per 21 CFR 801.109)