K Number
K081132
Device Name
SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM
Date Cleared
2008-07-14

(84 days)

Product Code
Regulation Number
888.3060
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SpineSmith Cequence Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine at one level between C2-C7 for the following indications: - . Degenerative disc disease [DDD] - defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - . Spondylolisthesis - Spinal Stenosis . - Tumors . - Trauma (i.e. fracture) .
Device Description
The Cequence anterior cervical plates are preassembled and are offered in both a constrained and semi-constrained configuration. Cequence consists of four (4) primary components: 1) anterior plate, 2) self-tapping bone screws, 3) locking screws and 4) locking plate.
More Information

KWQ

Not Found

No
The summary describes a mechanical implant (anterior cervical plate system) and its intended use for spinal fixation. There is no mention of AI, ML, image processing, or any software-driven functionality that would suggest the use of these technologies. The performance studies mentioned are mechanical tests, not algorithmic performance evaluations.

Yes
The device is intended for anterior screw fixation to the cervical spine to treat conditions like degenerative disc disease, spondylolisthesis, spinal stenosis, tumors, and trauma, which are therapeutic applications.

No

Explanation: The device description and intended use indicate it is an implantable plate system for spinal fixation, not a tool for diagnosing medical conditions.

No

The device description clearly outlines physical components (anterior plate, bone screws, locking screws, locking plate), indicating it is a hardware-based medical device.

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

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
  • Device Description: The SpineSmith Cequence Anterior Cervical Plate System is a surgical implant. It is a physical device designed to be surgically placed inside the body to stabilize the cervical spine.
  • Intended Use: The intended use is for "anterior screw fixation to the cervical spine," which is a surgical procedure.

The information provided clearly describes a surgical implant used for structural support within the body, not a device used for testing biological samples.

N/A

Intended Use / Indications for Use

The SpineSmith Cequence Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine at one level between C2-C7 for the following indications:

  • . Degenerative disc disease [DDD] - defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
  • . Spondylolisthesis
  • Spinal Stenosis .
  • Tumors .
  • Trauma (i.e. fracture) .

Product codes

KWQ

Device Description

The Cequence anterior cervical plates are preassembled and are offered in both a constrained and semi-constrained configuration. Cequence consists of four (4) primary components: 1) anterior plate, 2) self-tapping bone screws, 3) locking screws and 4) locking plate.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

cervical spine at one level between C2-C7

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)

Mechanical test results demonstrate that the proposed Cequence System is substantially equivalent to the predicate device.

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

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

K081132
Page 1 of 2

JUL 1 4 2008

SpineSmith Cequence Anterior Cervical Plate System 510(k) Summary of Safety and Effectiveness

SUBMITTED BY SpineSmith Partners, LP 8140 N. Mopac, Bldg II, Suite 120 Austin, TX 78759 ESTABLISHMENT 3006404071 REGISTRATION NUMBER Robert Jones CONTACT PERSON Vice President, Research and Development Phone: 512-206-0770 Fax: 512-637-6750 Email: rjones@spinesmithusa.com SUBMISSION PREPARED BY Lisa Peterson Kaedon Consulting, LLC Phone: 512-507-0746 April 18, 2008 DATE PREPARED CLASSIFICATION KWQ 888.3060- Spinal Intervertebral Body Fixation Orthosis Spinal Fixation System COMMON NAME PROPRIETARY NAME SpineSmith Cequence Anterior Cervical Plate System SUBSTANTIAL The SpineSmith Cequence System was determined to be EQUIVALENCE substantially equivalent to the predicate device.

DEVICE DESCRIPTION

The Cequence anterior cervical plates are preassembled and are offered in both a constrained and semi-constrained configuration. Cequence consists of four (4) primary components: 1) anterior plate, 2) self-tapping bone screws, 3) locking screws and 4) locking plate.

1

K081132
Page 2 of 2

INDICATIONS:

The SpineSmith Cequence Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine at one level between C2-C7 for the following indications:

  • . Degenerative disc disease [DDD] - defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
  • . Spondylolisthesis
  • Spinal Stenosis .
  • Tumors .
  • Trauma (i.e. fracture) .

MECHANICAL TEST DATA

Mechanical test results demonstrate that the proposed Cequence System is substantially equivalent to the predicate device.

2

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is a stylized eagle emblem with three stripes forming the wings and a ribbon-like element below.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Spinc Smith Partners, L.P. % Mr. Robert Jones 8140 North Mopac Building II, Suite 120 Austin, TX 78759

JUL 1 4 2008

Rc: K081132

Trade/Device Name: SpineSmith Partners, LP Cequence Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Names: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: June 27, 2008 Received: June 30, 2008

Dear Mr. Jones:

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.

3

Page 2 – Mr. Robert Jones

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial cquivalence of your device to a legally 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Miller

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

Enclosure

4

INDICATIONS FOR USE

510(k) Number (if known):

Device Name: SpineSmith Partners, LP Cequence Anterior Cervical Plate System

Indications for Use:

The SpineSmith Cequence Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine at one level between C2-C7 for the following indications:

  • Degenerative disc disease [DDD] defined as neck pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies
  • Spondylolisthesis .
  • Spinal Stenosis .
  • Tumors .
  • Trauma (i.e. fracture) .

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbare Buclind

(Division Sign-Division of General, Restorative, and Neurological Devices

510(k) Number_ (08 /132-