(63 days)
Not Found
No
The device description and intended use focus solely on the mechanical properties and physical design of a vertebral body replacement system. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The document explicitly states the device is a "vertebral body replacement system intended to replace a vertebral body" and is used during "tumor or trauma (i.e., fracture) management procedures," which are therapeutic interventions.
No
The device is a vertebral body replacement system, which is an implant used to replace a damaged vertebral body, not to diagnose a condition.
No
The device description explicitly states that the device consists of implants made of PEEK material and instrumentation for implantation, indicating it is a physical medical device, not software-only.
Based on the provided information, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Creaspine SupStance Small Vertebral Body Replacement System is a physical implant intended to replace a vertebral body in the spine. It is a surgical device used within the body, not for testing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the Creaspine SupStance Small Vertebral Body Replacement System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Creaspine SupStance Small Vertebral Body Replacement System is a vertebral body replacement system intended to replace a vertebral body. The SupStance Small VBR System is designed for use in the thoracolumbar spine (T1- L5) to replace a collapsed, damaged, or unstable vertebral body during tumor or trauma (i.e., fracture) management procedures. The SupStance Small VBR System is intended to be used with supplemental internal fixation systems. Anterior thoracolumbar plates and screws or pedicle screw and rod systems are among the options for the surgeon to use.
The use of allograft and/or autograft with the SupStance Small VBR System is optional.
Product codes
87 MQP
Device Description
The Creaspine SupStance Small Vertebral Body Replacement System is a vertebral body replacement system intended to replace a vertebral body. The SupStance Small VBR System consists of the SupStance Small VBR implants and the instrumentation required for implantation of the device. The SupStance Small VBR implant is a cage composed of fused hollow trapezoidal tubes with open sides and integral end caps. The SupStance Small VBR cages are available in three sizes (12mm, and 16mm) and cover a range of heights from 18mm to 50mm.
Like the sides of the cages, the SupStance Small VBR end caps have large openings for introduction of allograft and/or autograft and evenly spaced round serrations for fixation to the vertebral endplates. The end caps have a various (total) sagittal angle of 0°, 5°, and 8° to accommodate spinal anatomy.
The SupStance Small VBR cages are fabricated from poly-ether-ether-ketone (PEEK) with 6% BaSO4 contrast filler. The implants are provided non-sterile and may be implanted via an anterior approach or a costo-tranverse approach.
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
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Summary of Performance Studies
Performance testing included the types of mechanical testing recommended for vertebral body replacement systems (static and dynamic compression testing, static and dynamic torsion testing, and expulsion testing) in the "FDA Guidance for Industry and FDA Staff, Spinal System 510(k)s" (issued May 3, 2004). The data collected confirms that the mechanical properties of the proposed SupStance Small VBR System are comparable to those of the predicate devices.
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
MAY 2 9 2008
510(K) SUMMARY
Creaspine SupStance Small Vertebral Body Replacement System
| Proprietary Name: | Creaspine SupStance Small Vertebral Body
Replacement System |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Spinal Vertebral Body Replacement System |
| Proposed Regulatory Class: | Class II
Spinal intervertebral body fixation orthosis
21 CFR 888.3060 |
| Device Product Code: | 87 MQP, Spinal Vertebral Body Replacement Device |
| For Information Contact: | Marc Bernard
Regulatory Affairs Director |
| | PTIB Xavier Arnozan
Avenue du Haut-Lévèque
33600 Pessac - France
Telephone +33 557 102 854
Fax: +33 557 102 886
Email: marc.bernard@creaspine.com |
| Date Summary Prepared: | March 26, 2008 |
Predicate Devices
The Creaspine SupStance Small Vertebral Body Replacement System is substantially equivalent to the following legally marketed spinal vertebral body replacement devices:
- Surgical Titanium Mesh™ System (DePuy-Acromed™, Inc., K003043) .
- Surgical Dynamics Mesh Cage System (United States Surgical, K003709) .
- Spine Wave StaXx™ XD System (Spine Wave, K052670) .
Device Description
The Creaspine SupStance Small Vertebral Body Replacement System is a vertebral body replacement system intended to replace a vertebral body. The SupStance Small VBR System consists of the SupStance Small VBR implants and the instrumentation required for implantation of the device. The SupStance Small VBR implant is a cage composed of fused hollow trapezoidal tubes with open sides and integral end caps. The SupStance
1
Small VBR cages are available in three sizes (12mm, and 16mm) and cover a range of heights from 18mm to 50mm.
Like the sides of the cages, the SupStance Small VBR end caps have large openings for introduction of allograft and/or autograft and evenly spaced round serrations for fixation to the vertebral endplates. The end caps have a various (total) sagittal angle of 0°, 5°, and 8° to accommodate spinal anatomy.
The SupStance Small VBR cages are fabricated from poly-ether-ether-ketone (PEEK) with 6% BaSO4 contrast filler. The implants are provided non-sterile and may be implanted via an anterior approach or a costo-tranverse approach.
Intended Use
The Creaspine SupStance Small Vertebral Body Replacement System is a vertebral body replacement system intended to replace a vertebral body. The SupStance Small VBR System is designed for use in the thoracolumbar spine (T1- L5) to replace a collapsed, damaged, or unstable vertebral body during tumor or trauma (i.e., fracture) management procedures. The SupStance Small VBR System is intended to be used with supplemental internal fixation systems. Anterior thoracolumbar plates and screws or pedicle screw and rod systems are among the options for the surgeon to use.
The use of allograft and/or autograft with the SupStance Small VBR System is optional.
Statement of Technological Comparison
The subject components share the same intended use, basic design concepts, and materials as that of the predicate devices. Performance testing included the types of mechanical testing recommended for vertebral body replacement systems (static and dynamic compression testing, static and dynamic torsion testing, and expulsion testing) in the "FDA Guidance for Industry and FDA Staff, Spinal System 510(k)s" (issued May 3, The data collected confirms that the mechanical properties of the proposed 2004). SupStance Small VBR System are comparable to those of the predicate devices. The information and data collected support a claim of substantial equivalence for the proposed SupStance Small VBR System to the specified predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 2008
Creaspine % Medical Device Consultants, Inc. Ms. Cynthia J. Nolte Senior Regulatory Consultant 49 Plain Street North Attleboro, Massachusetts 02760
Re: K080860
Trade/Device Name: Creaspine SupStance Small Vertebral Body Replacement System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: March 26, 2008 Received: March 28, 2008
Dear Ms. Nolte:
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 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.
3
Page 2 – Ms. Cynthia J. Nolte
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Survcillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millican
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
510(k) Number (if known): K080860
Device Name: Creaspine SupStance Small Vertebral Body Replacement System
Indications for Use:
The Creaspine SupStance Small Vertebral Body Replacement System is a vertebral body replacement system intended to replace a vertebral body. The SupStance Small VBR System is designed for use in the thoracolumbar spine (T1- L5) to replace a collapsed, damaged, or unstable vertebral body during tumor or trauma (i.e., fracture) management procedures. The SupStance Small VBR System is intended to be used with supplemental internal fixation systems. Anterior thoracolumbar plates and screws or pedicle screw and rod systems are among the options for the surgeon to use.
The use of allograft and/or autograft with the SupStance Small VBR System is optional.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Ogle for nrm
Division Sign-Off
Division of General, Restorative, and Neurological Devices
510(k) Number K080860
Page 1 of 1
Creaspine Traditional 510(k) SupStance Small VBR System March 26, 2008