K Number
K082273
Device Name
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
Manufacturer
Date Cleared
2008-09-10

(30 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, posttraumatic kyphosis or lordosis, turnor, 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 Materials: alloy.
More Information

No
The summary describes a mechanical implant system and does not mention any software, algorithms, or data processing that would suggest the use of AI/ML.

Yes
The device is intended for anterior cervical intervertebral body fixation following anterior cervical fusion to achieve stability, and is indicated for various medical conditions like symptomatic cervical spondylosis, trauma, fracture, and degenerative disc disease, which are therapeutic purposes.

No

Explanation: The device, the UNIPLATE Anterior Cervical Plate System, is described as hardware (plates and screws) intended for surgical fixation following anterior cervical fusion. Its purpose is to provide stability, not to diagnose medical conditions.

No

The device description explicitly states it consists of plates, screws, and manual surgical instruments, which are hardware components.

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

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
  • Device Description: The UNIPLATE Anterior Cervical Plate System is described as an assortment of plates and screws intended for anterior cervical intervertebral body fixation. This is a surgical implant used directly within the body.
  • Intended Use: The intended use is for anterior cervical intervertebral body fixation to provide stability following anterior cervical fusion. This is a surgical procedure, not a diagnostic test performed on a specimen.

The information provided clearly indicates this is a surgical implant device, not a device used for in vitro diagnostic testing.

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, levels 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 per ASTM F 1717 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), 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

510(K) SUMMARYSEP 10 2008
Submitter:DePuy Spine, Inc.
325 Paramount Drive
Raynham, MA 02767
Contact Person:Frank Jurczak
Regulatory Affairs Associate
Voice: (508) 828-3288
Fax: (508) 828-3797
E-Mail: fjurczak@dpyus.jnj.com
Date Prepared:August 8, 2008
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)
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. | | |

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.

K082223 Page 2002

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

Performance Data: Performance data per ASTM F 1717 were submitted to characterize the subject UNIPLATE Anterior Cervical Plate System components addressed in this notification.

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, facing to the left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

SEP 1 0 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Depuy Spine, Inc. % Mr. Frank Jurczak Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767

K082273 Trade/Device Name: UNIPLATE Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis. Regulatory Class: II Product Code: KWO Dated: August 08, 2008 Received: August 11, 2008

Dear Mr. Jurczak:

Re:

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. Frank Jurczak

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence 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. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological 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): KO82273

Device Name: UNIPLATE Anterior Cervical Plate System

Indications For Usc:

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, turnor, 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 (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)

Mark A. Melleuson

Neurological Devices
510(k) Number K082273