(65 days)
Not Found
No
The description focuses on the mechanical properties and design of a physical implant (spinal cage) and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma and provide anterior spinal column support, directly addressing a health issue.
No
This device is a vertebral body replacement device, intended for structural support and replacement of damaged vertebrae, not for diagnosing conditions.
No
The device description clearly indicates it is a physical vertebral body replacement device made of spacers with specific heights, footprints, and protrusions, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damage or unstable vertebral body due to tumor or trauma." This describes a surgical implant used directly on the patient's body.
- Device Description: The description further clarifies that it's a "vertebral body replacement device used to provide structural stability... following corpectomy or vertebrectomy." This reinforces its role as a physical implant.
- Anatomical Site: The device is used in the "thoracolumbar spine (T1-L5)," which is a part of the human anatomy.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information about a patient's health.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases or conditions. This device is a surgical implant used to treat a structural problem in the spine.
N/A
Intended Use / Indications for Use
The Spinal Edge ATLAS Spinal Cage is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damage or unstable vertebral body due to tumor or trauma. The Spinal Edge ATLAS Spinal Cage is intended to be used with supplemental spinal fixation system that have been labeled for use in the thoracic and/or lumbar spine(i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer may if indicated be packed with bone grafting material. The Spinal Edge ATLAS Spinal Cage is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period of time.
Product codes
MQP
Device Description
The Spinal Edge ATLAS Spinal Cage is a vertebral body replacement device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients. Each spacer has an axial hole to allow optional grafting material to be packed inside of the spacer. Protrusions on the superior and inferior surfaces of each device will grip the cortical endplates of the adjacent vertebrae to resist expulsion
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
skeletally mature individuals
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
The testing was conducted to validate the ATLAS Spinal Cage in accordance with MTI Protocol PR465-0001 and ASTM F2077-03, "Test Methods for Intervertebral Body Fusion Devices" demonstration compliance.
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.
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5.0 510(k) Summary
1. Sponsor
JUN - 8 2006
Spinal Edge, LLC 780 W Army Trail Road # 218 Carol Stream, Illinois 60188-9297
| Primary Contact: | Yashdip Pannu M.D. |
|---|---|
| Telephone: | 630.903.4364 |
| Date Prepared: | April 5, 2006 (Revised May 23, 2006) |
2. Device Name:
| Proprietary Name: | ATLAS Spinal Cage |
|---|---|
| Common/Usual Name: | Spinal Vertebral Body Replacement Device |
| Classification Name: | Spinal Vertebral Body Replacement Device |
| (21 CFR 888 3060) Class II |
3. Predicate Devices
K990148 - Stackable Cage System - DePuy AcroMed, Inc. K040284 - Sustain Radiolucent Spacer - Globus Medical, Inc.
4. Device Description
The Spinal Edge ATLAS Spinal Cage is a vertebral body replacement device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients. Each spacer has an axial hole to allow optional grafting material to be packed inside of the spacer. Protrusions on the superior and inferior surfaces of each device will grip the cortical endplates of the adjacent vertebrae to resist expulsion
5. Intended Use
The Spinal Edge ATLAS Spinal Cage is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damage or unstable vertebral body due to tumor or trauma. The Spinal Edge ATLAS Spinal Cage is intended to be used with supplemental spinal fixation system(s) that have been labeled for use in the thoracic and/or lumbar spine (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer may if indicated
Spinal Edge, LLC ATLAS Spinal Cage - 510(k)
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K060916
be packed with bone grafting material. The Spinal Edge ATLAS Spinal Cage is designed to provide anterior spinal column support for a prolonged period of time even in the absence of fusion.
6. Technological Characteristics and Substantial Equivalent
The ATLAS Spinal Cage and its predicate devices have the same indications for use and are made of the same materials. Testing to demonstrate with FDA's Guidance for Spinal System 510(k) May 3, 2004 was combleted for the Spinal Edge ATLAS Spinal Cage.
7. Performance Testing
The testing was conducted to validate the ATLAS Spinal Cage in accordance with MTI Protocol PR465-0001 and ASTM F2077-03, "Test Methods for Intervertebral Body Fusion Devices" demonstration compliance.
ge 2 of 2
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest the shape of a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 8 2006
Spinal Edge, LLC c/o Ms. Christina Vacca 25125 Detroit Road Westlake, Ohio 44145
Re: K060916
Trade/Device Name: ATLAS Spinal Cage System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: April 4, 2006 Received: April 4, 2006
Dear Ms. Vacca:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications ferenced above and have a no legally marketed predicate devices marketed in interstate for use stated in the encreases) is the enactment date of the Medical Device Amendments, or to continer to provision to ridge 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 I ou may, diereleve, mains 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 If your de rice is elassinon 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 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.
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Page 2 – Ms. Christina Vacca
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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Herbert Simonus
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 4.0
10609 in 510(k) Number (if Known): __
Indications For Use:
The Spinal Edge ATLAS Spinal Cage is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damage or unstable vertebral body due to tumor or trauma. The Spinal Edge ATLAS Spinal Cage is intended to be used with supplemental spinal fixation system that have been labeled for use in the thoracic and/or lumbar spine(i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer may if indicated be packed with bone grafting material. The Spinal Edge ATLAS Spinal Cage is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period of time.
Prescription Use: X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use: (Part 21 CFR 807 Subpart C)
Herbert Lemmer
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
1-06 0916 510(k) Number_
Spinal Edge, LLC ATLAS Spinal Cage - 510(k) April 5, 2006 Company Confidential