K Number
K100070
Device Name
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
Manufacturer
Date Cleared
2010-02-04

(24 days)

Product Code
Regulation Number
888.3060
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UNIPLATE Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2-T1. Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.
Device Description
The UNIPLATE Anterior Cervical Plate System consists of an assortment of plates and screws. The UNIPLATE Anterior Cervical Plate System also contains Class I manual surgical instruments and cases that are considered exempt from premarket notification. Manufactured from ASTM F 136 implant grade titanium alloy.
More Information

Not Found

No
The 510(k) summary describes a mechanical implant system (plates and screws) and manual surgical instruments. There is no mention of AI, ML, image processing, or any software component that would suggest the use of these technologies. The performance studies mentioned likely relate to mechanical testing of the implant.

Yes
The device is intended for "anterior cervical intervertebral body fixation" to provide "stability...following anterior cervical fusion" for various medical conditions like "symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease...spinal stenosis, re-operation for failed fusion, or instability". These applications are therapeutic in nature, aimed at treating or alleviating a disease or injury.

No

The provided text describes the UNIPLATE Anterior Cervical Plate System as an implant for fixation following anterior cervical fusion, not a device used to diagnose medical conditions. Its purpose is structural support, not diagnosis.

No

The device description explicitly states that the system consists of plates, screws, and surgical instruments, which are physical hardware components.

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

Here's why:

  • Intended Use: The intended use clearly states "anterior cervical intervertebral body fixation." This describes a surgical implant used to stabilize the spine.
  • Device Description: The device consists of "plates and screws" made from titanium alloy, which are typical components of surgical implants.
  • Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests. It is a physical implant.

The information provided describes a surgical implant used for spinal fusion, not a diagnostic test performed on biological samples.

N/A

Intended Use / Indications for Use

The UNIPLATE Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2-T1.

Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.

Product codes

KWQ

Device Description

The UNIPLATE Anterior Cervical Plate System consists of an assortment of plates and screws. The UNIPLATE Anterior Cervical Plate System also contains Class I manual surgical instruments and cases that are considered exempt from premarket notification.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Cervical spine, ranging from C2-T1

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)

Performance data were submitted to characterize the subject UNIPLATE Anterior Cervical Plate System components addressed in this notification.

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

Not Found

Predicate Device(s)

UNIPLATE Anterior Cervical Plate System (K042544), UNIPLATE Anterior Cervical Plate System (K082273), EAGLE Anterior Cervical Plate System (K040197)

Reference Device(s)

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

5. 510(K) SUMMARY

Submitter: DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02767

FEB - 4 2010

Contact Person: Christopher Rogers Manager, Regulatory Affairs Voice: (508) 828-3224 Fax: (508) 828-3797 E-Mail: crogers4@its.jnj.com

Date Prepared: January 8, 2010

Device Class: Class II

Classification Name: Spinal intervertebral body fixation orthosis per 21 CFR §888.3060

Classification Panel: Orthopedics

FDA Panel Number: 87

Product Code(s): KWQ

Proprietary Name: UNIPLATE Anterior Cervical Plate System

Predicate Devices: UNIPLATE Anterior Cervical Plate System (K042544) UNIPLATE Anterior Cervical Plate System (K082273) EAGLE Anterior Cervical Plate System (K040197)

Device Description: The UNIPLATE Anterior Cervical Plate System consists of an assortment of plates and screws

The UNIPLATE Anterior Cervical Plate System also contains Class I manual surgical instruments and cases that are considered exempt from premarket notification.

  • Intended Use: The UNIPLATE Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2-T1.
    DePuy Spine, Inc., a Johnson & Johnson Company

1

Special 510(k) Submission - Additions to UNIPLATE Anterior Cervical Plate System

Indications include symptomatic cervical spondylosis. trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.

Manufactured from ASTM F 136 implant grade titanium Materials: alloy.

Performance Data: Performance data were submitted to characterize the subject UNIPLATE Anterior Cervical Plate System components addressed in this notification.

2

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around the perimeter. In the center of the seal is a stylized emblem, which is a modern interpretation of the Public Health Service (PHS) symbol, often referred to as the "Corps Device" or the "Caduceus."

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

DePuy Spine, Inc. % Mr. Christopher Rogers Manager, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767

FEB - 4 2010

Re: K100070

Trade/Device Name: UNIPLATE Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 08, 2010 Received: January 11, 2010

Dear Mr. Rogers:

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

3

Page 2 - Mr. Christopher Rogers

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Safety/ReportaProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Barbara Buettner

Mark N. Me Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

Special 510(k) Submission - Additions to UNIPLATE Anterior Cervical Plate System

4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: UNIPLATE Anterior Cervical Plate System

Indications For Use:

The UNIPLATE Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2-T1.

Indications include symptomatic cervical spondylosis, trauma, fracture, posttraumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K100070 510(k) Number_

DePuy Spine, Inc., a Johnson & Johnson Company

Page 4-1