(30 days)
Not Found
No
The summary describes a physical implant (titanium mesh system) and its intended use in spinal surgery. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies mentioned are biomechanical tests, not related to algorithmic performance.
Yes
The device is described as being used to replace diseased vertebral bodies, treat fractures, and restore biomechanical integrity, which are all therapeutic actions.
No
The device is a surgical implant (Surgical Titanium Mesh System) used to replace or stabilize vertebral bodies, not to diagnose medical conditions.
No
The device is a Surgical Titanium Mesh System, which is a physical implant used in spinal surgery, not a software-only device.
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.
- 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 thoracolumbar spine to treat conditions like tumors and fractures. This is a therapeutic and structural device, not a diagnostic test.
The information provided aligns with a surgical implant device, 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 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), thoracic and lumbar spine
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): 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.
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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
Surgical Titanium Mesh™ System
:
Comments of Children
ﭘ State of the country of the count
| IX. 510(k) Summary | |
|---|---|
| SUBMITTER: | DePuy AcroMed™, Inc. |
| 325 Paramount Drive | |
| Raynham, MA 02767-0350 USA | |
| MAR 21 2002 | |
| CONTACT PERSON: | Karen F. Jurczak |
| DATE PREPARED: | February 15, 2002 |
| PROPRIETARY NAME: | Surgical Titanium Mesh™ System |
| CLASSIFICATION NAME: | Implant, fixation device |
| Spinal intervertebral body fixation orthosis device | |
| PREDICATE DEVICE: | Surgical Titanium Mesh System (K003043) |
| Surgical Dynamics Mesh Cage System (K003709) | |
| 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 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. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the 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" around the perimeter. Inside the circle is a stylized symbol of three abstract human figures or profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frank Maas Regulatory Affairs Manager DePuy Acromed 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re:
K020522 Trade Name: Surgical Titanium Mesh System Regulation Number: 888.3060 Regulation Name: Vertebral Body Replacement Device Class: II Product Code: MQP Dated: February 15, 2002 Received: February 19, 2002
Dear Mr. Maas:
We have reviewed your Section 510(k) notification of intent to market the device referenced above we have reviewed your Society is substantially equivalent (for the indications for use stated in allo we have determined the device is substantially of the enaments on on the enactment alte the Medical Device Amendments, or to devices that have been reclassified in accordance with the or the Medical Dovice I michaments, or ad Cosmetic Act (Act). You may, therefore, market the provisions of the roderal rood, Dreg, and visions of the Act. The general controls provisions of the device, subject to the general ecistration, 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 (Premarket If your device is olassified (500 above) aitional controls. Existing major regulations affecting your Approval), it thay be subject to back as a substions, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice equirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requirement, as set form in the Quant) "hough periodic (QS) inspections, the Food and Drug regulation (FDA) will verify such assumptions. Failure to comply with the GMP regulation Administration (1 Dry Prify Pactives, FDA may publish further announcements concerning may result in the Federal Register. Please note: this response to your premarket notification your device in the Peachar 100 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 - Mr. Frank Maas
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 noutication. THC PDA miding of substantial vour 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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) additionally 007.10 for in This anaghoon the promotion and advertising of your device, please 574-4639. Traditionally, 10. quests (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information "Wisolanding of reference to premation in the Division of Small Manufacturers on your responsibilities ander the rice may of at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Mark A. Williams
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 100 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 and Profile).
Mark N. Milken
(Division Sig-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number _
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Over-The-Counter Use: Prescription Use: (Per 21 CFR 801.109)
DePuy AcroMed, Inc. 510(K)