K Number
K030249
Device Name
SURGICAL TITANIUM MESH SYSTEM
Manufacturer
Date Cleared
2003-02-14

(21 days)

Product Code
Regulation Number
888.3060
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Surgical Titanium Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Surgical Titanium Mesh System is also indicated for treating fractures of the thoracic and lumbar spine. The Surgical Titanium Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The Surgical Titanium Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Surgical Titanium Mesh System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch and Profile).
Device Description
Not Found
More Information

No
The 510(k) summary describes a physical implant (Surgical Titanium Mesh System) and its intended use and performance testing (biomechanical). There is no mention of software, algorithms, image processing, or terms related to AI/ML.

Yes.
The device is used to treat medical conditions such as tumors and fractures in the thoracolumbar spine, providing therapeutic benefits by restoring spinal integrity and decompressing neural tissues.

No
Explanation: The Surgical Titanium Mesh System is an implantable device used to replace or stabilize parts of the spine. Its function is reconstructive and supportive, not to diagnose medical conditions through data analysis or imaging.

No

The device description and intended use clearly describe a physical implant (Surgical Titanium Mesh System) used in spinal surgery, which is a hardware device. There is no mention of software as the primary or sole component.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes a surgical implant used to replace or support vertebral bodies in the spine. This is a therapeutic device, not a diagnostic one.
  • Device Description (Not Found): While the description is missing, the intended use strongly suggests a physical implant.
  • No mention of biological samples: IVDs typically involve testing biological samples (blood, urine, tissue, etc.) to diagnose or monitor a condition. There is no mention of this here.
  • No mention of diagnostic purpose: The purpose is to restore structural integrity and achieve decompression, not to diagnose a disease.

Therefore, the Surgical Titanium Mesh System is a surgical implant, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The Surgical Titanium Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

The Surgical Titanium Mesh System is also indicated for treating fractures of the thoracic and lumbar spine.

The Surgical Titanium Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

The Surgical Titanium Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Surgical Titanium Mesh System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch and Profile).

Product codes

MQP

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

thoracolumbar spine (T1-L5)

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)

Biomechanical testing, including static axial compression and dynamic axial compression, were conducted.

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

Not Found

Predicate Device(s)

K003043, K020522

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

1
(f
VI
  • | | |

Surgical Titanium Mesh™ System

VIII. 510(k) Summary

| SUBMITTER: | DePuy AcroMed ™ , Inc.
325 Paramount Drive
Raynham, MA 02767-0350 USA | FEB 1 4 2003 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| CONTACT PERSON: | Karen F. Jurczak | |
| DATE PREPARED: | January 24, 2003 | |
| PROPRIETARY NAME: | Surgical Titanium Mesh ™ System | |
| CLASSIFICATION NAME: | Implant, fixation device
Spinal intervertebral body fixation orthosis device | |
| PREDICATE DEVICE: | Surgical Titanium Mesh System (K003043, K020522) | |
| INTENDED USE: | The Surgical Titanium Mesh System is indicated for use in
the thoracolumbar spine (T1-L5) to replace a diseased
vertebral body resected or excised for the treatment of
tumors, to achieve anterior decompression of the spinal
cord and neural tissues, and to restore the height of a
collapsed vertebral body. | |
| | The Surgical Titanium Mesh System is also indicated for
treating fractures of the thoracic and lumbar spine. | |
| | The Surgical Titanium Mesh System is designed to restore
the biomechanical integrity of the anterior, middle, and
posterior spinal column even in the absence of fusion for a
prolonged period. | |
| | The Surgical Titanium Mesh System is intended for use
with supplemental internal fixation. The supplemental
internal fixation systems that may be used with the
Surgical Titanium Mesh System include DePuy AcroMed
titanium plate or rod systems (e.g. Kaneda SR, University
Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch and
Profile). | |
| MATERIALS: | Titanium alloy (Ti-6Al-4V) | |
| PERFORMANCE
DATA: | Biomechanical testing, including static axial compression
and dynamic axial compression, were conducted. | |

1

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them, resembling a bird or flowing water. The logo is rendered in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2003

Mr. Frank Maas Director, Regulatory Affairs DePuy Acromed 325 Paramount Drive Raynham, Massachusetts 02767-0350

K030249 Re:

Trade Name: Titanium Mesh System - Addition of Components Regulation Number: 21 CFR 888.3060 Regulation Name: Vertebral Body Replacement Device Regulatory Class: II Product Code: MQP Dated: January 23, 2003 Received: January 24, 2003

Dear Mr. Maas:

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.

2

Page 2 - Mr. Frank Maas

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. 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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark M. Millhuser

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

III. Indications for Use

510(k) Number (if known): K030249

Surgical Titanium Mesh 10 System Device Name:

Indications For Use:

The Surgical Titanium Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

The Surgical Titanium Mesh System is also indicated for treating fractures of the thoracic and lumbar spine.

The Surgical Titanium Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

The Surgical Titanium Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Surgical Titanium Mesh System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch and Profile).

for Mark n Millerson
Division Sign-Off

Division of
and Neurology

510(k) Number: K03,0249

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:
(Per 21 CFR 801.109)

OR Over-The-Counter Use: