(221 days)
Not Found
No
The 510(k) summary describes a physical implant (titanium mesh system) and its intended use and performance testing. There is no mention of AI, ML, image processing, or any software-based functionality that would suggest the use of these technologies.
Yes
The device is used to treat tumors and fractures, and to restore the height of a collapsed vertebral body, which are therapeutic interventions.
No
The provided text describes the Surgical Titanium Mesh System as a device used to replace diseased vertebral bodies and treat spinal fractures, restoring biomechanical integrity. It is an implantable device for treatment, not for diagnosing conditions.
No
The device is described as a "Surgical Titanium Mesh System" intended for use in the spine, which is a physical implantable device made of titanium. The description of biomechanical testing and clinical data further supports that this is a hardware device, not software.
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 (in vitro).
- Device Description: The provided information describes a Surgical Titanium Mesh System intended for implantation in the spine to replace or support vertebral bodies. This is a surgical implant used within the body.
- Intended Use: The intended use clearly states the device is for surgical procedures on the spine to treat conditions like tumors and fractures. This is a therapeutic and structural device, not a diagnostic one.
The information provided aligns with a surgical implant device, not an IVD.
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. Bone graft material is recommended to be packed inside of the mesh cage prior to implantation.
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 and Profile).
Product codes (comma separated list FDA assigned to the subject device)
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. Clinical data were provided to demonstrate the performance of the device in patients with spine tumors.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
| IX. 510(k) Summary | MAY - 8 2001 | K003043 |
|---|---|---|
| SUBMITTER: | DePuy AcroMed ™, Inc. | |
| 325 Paramount Drive | ||
| Raynham, MA 02767-0350 USA | ||
| CONTACT PERSON: | Karen F. Jurczak | |
| DATE PREPARED: | April 13, 2001 | |
| PROPRIETARY NAME: | Surgical Titanium Mesh™ System | |
| CLASSIFICATION NAME: | Implant, fixation device | |
| Spinal intervertebral body fixation orthosis device | ||
| PREDICATE DEVICE: | Stackable Cage System (K990148) | |
| Rezaian Spinal Fixator (K841189) | ||
| 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. Bone graft material is recommended to
be packed inside of the mesh cage prior to implantation.
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 and Profile). | |
| MATERIALS: | Commercially Pure (CP) Titanium
Titanium alloy (Ti-6Al-4V) | |
| PERFORMANCE
DATA: | Biomechanical testing, including static axial compression
and dynamic axial compression, were conducted.
Clinical data were provided to demonstrate the
performance of the device in patients with spine tumors. | |
:
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract human form or a caduceus without the snake, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 8 2001
Ms. Karen F. Jurczak Regulatory Affairs Associate DePuy AcroMed 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K003043
Trade/Device Name: Surgical Titanium Mesh System Regulation Number: Unclassified Product Code: MQP Dated: April 13, 2001 Received: April 16, 2001
Dear Ms. Jurczak:
We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your becaon 910(x) health in the substantially equivalent (for the indications for use above and we nave determined the actrected predicate devices marketed in interstate commerce stated in the enclosure) to legally manufacted ptthe Medical Device Amendments, or to devices that provision in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act). Tou may, atererors, and controls provisions of the Act include requirements for annual provisions of the Act. "The general countincturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remance rippioval), it they of our control in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspections, the Food and Desult in regulatory action. In addition, FDA may publish Compy with ans Concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Ms. Karen F. Jurczak
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The I Dri imaling of succion 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 and If you desire specific advice for your as ic devices), please contact the Office of Compliance at additionally 607.10 for in Thio diagnestions on the promotion and advertising of your device, (201) 594-4637. Rudinonary, 18. quise at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small
information on your responsibilities under the Act may be obtained in 16507 watc Illionnation on your responsibilities and more (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
rominhellon propri
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
IV. Indications for Use
510(k) Number (if known):
Surgical Titanium Mesh™ 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. Bone graft material is recommended to be packed inside of the mesh cage prior to implantation.
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 and Profile).
commhaeeetoton auu
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K002043
(Please do not write below this line - continue on another page if needed)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use: | |
| OR Over-The-Counter | |
| Use: | |
| (Per 21 CFR 801.109) |
DePuy AcroMed Inc
Page B 2uy AcroMed, Inc. Indications For Use