(227 days)
Not Found
No
The summary describes a mechanical implant and its associated fixation system, with no mention of software, algorithms, or any form of data processing that would suggest AI/ML.
Yes
The device is indicated for use in the thoracolumbar spine to replace a diseased vertebral body, achieve anterior decompression, and restore vertebral body height, all of which are direct treatments for medical conditions.
No
The device is a medical implant (Stackable Cage System) used for spinal surgery, specifically to replace diseased vertebral bodies. Its purpose is to restore biomechanical integrity and height, not to diagnose a condition.
No
The device description clearly states the system consists of physical components made of polymer/carbon fiber composite and titanium alloy, which are hardware implants.
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 vertebral bodies and restore spinal integrity. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant made of polymer/carbon fiber composite and titanium, designed for surgical implantation. This is consistent with a medical device used in surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition. The "normal radiographic methods" mentioned are used to assess healing after the device is implanted, not for initial diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Stackable Cage" System is indicated for use in the thoracolumbar spine (i.e., T1 to LS) 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 Stackable Cage 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 Stackable Cage system is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Stackable Cage 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
MOP
Device Description
The Stackable Cage System consists of two componentsone or more stackable vertebral body replacement components (stackable cage implants) and a supplemental internal fixation system. The stackable cage implant is made of a polymer/carbon fiber composite material. One or more stackable cage implants may be stacked to the desired height, as determined by the surgeon. A titanium alloy screw can be passed through a center hole in the cages and with a nut provide a rigid and compressed assembly.
The structure of the stackable cage implants has been shown to support anticipated loads with a modulus of elasticity approximating that of cortical bone. The implants have ridges or teeth in both the anterior-posterior and mediallateral directions, which resist rotation and migration. The stackable cage implants have cavities to accept packing of bone graft. The entire structure is radiolucent so that healing can be assessed by normal radiographic methods. Additionally, radiotherapy can be performed immediately after surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (i.e., T1 to 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
Biomechanical testing, including static axial compression, torsional loading and cantilever beam testing, were conducted.
Clinical data were provided to demonstrate the performance of the device in patients with spine tumors.
Key Metrics
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
SEP 3 1999
STACKABLE CAGE™ SYSTEM 510(k) SUMMARY
COMPANY:
Stackable Cage " System
DePuy AcroMed™, Inc.
325 Paramount Drive Raynham, MA 02767-0350 USA
Stackable Cage™ System TRADE NAME:
888.3060 CLASSIFICATION:
Implant, fixation device, spinal intervertebral body fixation orthosis devices
DESCRIPTION:
The Stackable Cage System consists of two componentsone or more stackable vertebral body replacement components (stackable cage implants) and a supplemental internal fixation system. The stackable cage implant is made of a polymer/carbon fiber composite material. One or more stackable cage implants may be stacked to the desired height, as determined by the surgeon. A titanium alloy screw can be passed through a center hole in the cages and with a nut provide a rigid and compressed assembly.
The structure of the stackable cage implants has been shown to support anticipated loads with a modulus of elasticity approximating that of cortical bone. The implants have ridges or teeth in both the anterior-posterior and mediallateral directions, which resist rotation and migration. The stackable cage implants have cavities to accept packing of bone graft. The entire structure is radiolucent so that healing can be assessed by normal radiographic methods. Additionally, radiotherapy can be performed immediately after surgery.
Carbon-fiber reinforced polymer and titanium alloy MATERIAL:
INDICATIONS:
The Stackable Cage System is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal
880-3 11888888 ട്ടാ-1
1
cord and neural tissues, and to restore the height of a collapsed vertebral body.
The Stackable Cage 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 Stackable Cage System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Stackable Cage System include DePuy AcroMed titanium plate or rod systems (e.g., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss, TiMX, Profile).
PERFORMANCE DATA:
Biomechanical testing, including static axial compression, torsional loading and cantilever beam testing, were conducted.
Clinical data were provided to demonstrate the performance of the device in patients with spine tumors.
SUBSTANTIAL EQUIVALENCE:
The Stackable Cage System is substantially equivalent to the Rezaian Spinal Fixator (K841189). The claim of substantial equivalence is made solely for regulatory purposes and shall not be deemed to be an assertion of equivalence under U.S. and international patent laws.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP . 3 1999
Mr. William Christianson Vice President, Regulatory Affairs DePuy AcroMed, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K990148 Trade Name: Stackable CagerM System Regulatory Class: II Product Code: MOP Dated: June 4, 1999 Received: June 7, 1999
Dear Mr. Christianson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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.
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Page 2 -- Mr. William Christianson
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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) NUMBER (IF KNOWN): K990148
DEVICE NAME: Stackable Cage" System
INDICATIONS FOR USE:
The Stackable Cage" System is indicated for use in the thoracolumbar spine (i.e., T1 to LS) 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 Stackable Cage 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 Stackable Cage system is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Stackable Cage System include DePuy AcroMed titanium plate or rod systems (e.g., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, and Profile).
Concurrent of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-the-Counter-Use | |
|---|---|---|---|---|
| (per 21 CFR 801.109) |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K990148 |
K990148: Stackable Cage System
DePuy AcroMed: September 1, 1999