(195 days)
No
The device description focuses on the physical characteristics and mechanical function of a titanium mesh implant for spinal surgery. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma, to achieve anterior decompression of the spinal cord, and to restore the height of a collapsed vertebral body, which are therapeutic actions.
No.
The provided text describes the Titanium Mesh System as a vertebral body replacement system used to restore the biomechanical integrity and height of the spinal column, primarily in cases of tumor or trauma. Its function is to replace or support, not to diagnose.
No
The device description clearly details a physical implant made of titanium mesh, end caps, and a cutting tool, which are all hardware components. There is no mention of any software component.
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.
- Device Description: The provided text describes a surgical implant (Titanium Mesh System) used to replace vertebral bodies in the spine. It is a physical device implanted into the body during surgery.
- Intended Use: The intended use is to restore the structural integrity of the spine after damage or collapse due to tumor or trauma. This is a therapeutic and structural function, not a diagnostic test performed on a sample.
The device is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Titanium Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture), to achieve anterior decompression of the spinal cord and other neutral tissues, and to restore the height of a collapsed vertebral body. The Titanium Mesh 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
Product codes
MQP
Device Description
The Titanium Mesh is a vertebral body replacement system comprised of several different cross-sectional shaped implants with various heights. The different cross-sectional shaped shapes include: round, oval, oblong and kidney (banana) shaped implants. The height of the implants varies from 7mm to 130mm. In addition, some of the implants are trapezoidal, i.e., the posterior side of the implant is lower than the anterior side of the implant. A cutting tool allows for trimming of the implants to the desired height at surgical site. The interior of the mesh is open and provides a space that can be filled with bone graft material. The sidewalls of the mesh are perforated by several holes and allow for bone fusion through the sidewalls of the mesh. There are several ribs running longitudinally along the internal walls of the mesh. Standard and trapezoidal end caps that correspond to the various cross-sectional shapes of meshes are included in the system. The end caps are placed on top of and supported by the longitudinal ribs located at the internal wall of the mesh. Also the end caps have prongs that provide a friction-locking feature between the caps and the ribs of the mesh. The end caps are manually pressed into the mesh. Serrations on the superior/inferior surface of the end caps provide stability and prevent movement of the implant.
The Titanium Mesh System is intended for use with supplemental internal fixation spinal systems.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
142
| K032371 |
|---|
| --------- |
| SUBMITTER: | Encore Orthopedics, Inc.
9800 Metric Blvd
Austin, TX 78758 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Kimberly L. Pruitt
(512) 834-6291 |
| PROPRIETARY NAME: | Titanium Mesh |
| COMMON NAME: | Titanium Mesh |
| CLASSIFICATION NAME: | Per CFR 21, §888.3060: Implant, fixation, spinal
intervertebral body fixation orthosis devices |
| PRODUCT CLASSIFICATION: | Class II |
| DEVICE PRODUCT CODE: | MQP |
| PREDICATE DEVICE: | (K003275) SynMesh™ Spacer System
(K003709) Surgical Dynamics™
Mesh Cage System
(K003043) DePuy AcroMed™ Surgical Titanium
Mesh™ System |
| DEVICE DESCRIPTION: | The Titanium Mesh is a vertebral body
replacement system comprised of several different
cross-sectional shaped implants with various
heights. The different cross-sectional shaped
shapes include: round, oval, oblong and kidney
(banana) shaped implants. The height of the
implants varies from 7mm to 130mm. In addition,
some of the implants are trapezoidal, i.e., the
posterior side of the implant is lower than the
anterior side of the implant. A cutting tool allows
for trimming of the implants to the desired height
at surgical site. The interior of the mesh is open
and provides a space that can be filled with bone
graft material. The sidewalls of the mesh are
perforated by several holes and allow for bone
fusion through the sidewalls of the mesh. There
are several ribs running longitudinally along the
internal walls of the mesh.
Standard and trapezoidal end caps that correspond
to the various cross-sectional shapes of meshes are
included in the system. The end caps are placed on |
Titanium Mesh 510(k) Summary of Safety and Effectiveness
1
242
K032371
top of and supported by the longitudinal ribs located
at the internal wall of the mesh. Also the end caps
have prongs that provide a friction-locking feature
between the caps and the ribs of the mesh. The end
caps are manually pressed into the mesh. Serrations
on the superior/inferior surface of the end caps
provide stability and prevent movement of the
implant.
The Titanium Mesh System is intended for use with
supplemental internal fixation spinal systems.
INTENDED USE:
The Titanium Mesh System is indicated for use in
the thoracolumbar spine (T1-L5) to replace a
collapsed, damaged, or unstable vertebral body due
to tumor or trauma (i.e. fracture), to achieve anterior
decompression of the spinal cord and other neutral
tissues, and to restore the height of a collapsed
vertebral body. The Titanium Mesh 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
BASIS OF
SUBSTANTIAL
EQUIVALENCE:
The Titanium Mesh System is similar in
indications, material and design to the SynMesh™
Spacer System (K003275), the Surgical Dynamics™
Mesh Cage System (K003709) and the DePuy
AcroMed™ Surgical Titanium Mesh™ System
(K003043).
MATERIALS:
The Titanium Mesh System is manufactured from
surgical grade titanium alloy as described by
ASTM F-1108 (Ti-6Al-4V).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the seal is an abstract symbol that resembles three parallel lines above a wavy line.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 2004
Ms. Kimberly L. Pruitt Clinical Research Associate Encore Medical I .. P. 9800 Metric Boulevard Austin, Texas 78758
Re: K032371
Trade/Device Name: Titanium Mesh System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: January 23, 2004 Received: January 26, 2004
Dear Ms. Pruitt:
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 I'DA'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 - Ms. Kimberly L. Pruitt
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in your e FDA finding of substantial equivalence of your device to a legally promance neticate 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
Sincercly vours.
L-Mark N. Milburn
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
4
| 510(k) Number (if known): | K032371 - | - while and the count of the count of the count of the first and while the first and while the first and other the collection, | Comments of the Concession Concession in Concession | |||
|---|---|---|---|---|---|---|
| --------------------------- | -- | ----------- | -- | -- | -------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------- |
Titanium Mesh System Device Name:
Indications For Use:
Titanium Mesh System Indications For Use
The Titanium Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture), to achieve anterior decompression of the spinal cord and other neutral tissues, and to restore the height of a collapsed vertebral body. The Titanium Mesh 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
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use צ (per 21 CFR 801.109)
OR
Over-The-Counter Use __
(Optional Format 1-2-96)
Mark n Milkeum
(Division Sign-Division of General, Restorative, and Neurological Devices
510(K) Number K032371