(259 days)
No
The summary describes a vertebral body replacement system, a physical implant, and focuses on its mechanical properties and clinical outcomes. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a vertebral body replacement system used to treat diseased or damaged vertebral bodies, indicating a therapeutic purpose.
No
Explanation: Trabis® is a vertebral body replacement system, which is a medical implant used for reconstruction and stabilization of the spine, not for diagnosing conditions.
No
The device is a vertebral body replacement system, which is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Trabis® Description: The description clearly states that Trabis® is a "vertebral body replacement system" and an "implant." It is a physical device intended to be surgically implanted into the cervical spine.
- Intended Use: The intended use is to replace diseased or damaged vertebral bodies and for reconstruction following corpectomy. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
- Performance Studies: The performance studies described are non-clinical tests related to the mechanical properties of the implant (compression, torsion, subsidence) and a clinical study evaluating surgical outcomes and radiological findings after implantation. These are not studies related to the accuracy or performance of a diagnostic test.
Therefore, Trabis® is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Trabis® is a vertebral body replacement system indicated for use in the cervical spine (from C2 to T1 vertebral bodies) in skeletally mature patients to replace or damaged vertebral body caused by turnor, fracture, or osteomyelitis, or for reconstruction following corpectorned to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. Trabis® is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.
These implants are intended for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft, as an adjunct to fusion. Trabis® is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage turnors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
Product codes
PLR
Device Description
The devices included in this submission are a subset of the devices that were included in the OstaPek® VBR System, cleared in K072326. The only difference between the Trabis® and the K072326 subset is that the Trabis® VBR are intended for the use in the cervical spine, whereas the devices cleared in K072326 were cleared for use in the thoracolumbar spine. Therefore, the purpose of this 510(k) is to modify the Indications for Use for the subject Trabis®.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (from C2 to T1 vertebral bodies)
Indicated Patient Age Range
skeletally mature patients
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
Non-clinical Test Summary: The following analyses were conducted:
• Static and dynamic compression per ASTM F2077
• Static and dynamic torsion per ASTM F2077
• Subsidence per ASTM F2267
The results of these evaluations indicate that Trabis® is equivalent to predicate devices.
Clinical Test Summary: A study was presented analyzing the outcome and radiological findings for anterior cervical corpectomy with the use of carbon composite Trabis®, as a support with space for grafts after cervical corpectomy of one or more levels, performed at three centers. All cervical corpectomy cases performed between June 2000 and May 2006 were retrospectively reviewed. Ninety-three patients were treated with the Trabis® after cervical corpectomy of one or more levels for different reasons.
Key Metrics
Not Found
Predicate Device(s)
Cardinal Spine C-VBR (K152568), ostaPek® VBR System (K072326)
Reference Device(s)
ACIF (K173148)
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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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services, which features a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA). The FDA logo includes the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" written below in a smaller font.
September 6, 2018
coLigne, AG % J. D. Webb Official Correspondent The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681
Re: K173893
Trade/Device Name: Trabis® Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: PLR Dated: August 3. 2018 Received: August 6, 2018
Dear Mr. Webb:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Melissa Hall -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Trabis®
Indications for Use (Describe)
Trabis® is a vertebral body replacement system indicated for use in the cervical spine (from C2 to T1 vertebral bodies) in skeletally mature patients to replace or damaged vertebral body caused by turnor, fracture, or osteomyelitis, or for reconstruction following corpectorned to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. Trabis® is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.
These implants are intended for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft, as an adjunct to fusion. Trabis® is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage turnors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ✔ Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary: Trabis®
| Date Prepared | September 5, 2018 |
|---|---|
| Submitted By | Robert Lange |
| coLigne, AG | |
| Utoquai 43 | |
| CH 8008 Zurich | |
| Switzerland | |
| Telephone: +41 43 343 8000 | |
| e-mail: robert.lange@coligne.com | |
| Primary Contact | J.D. Webb |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| 512-388-0199 Tele | |
| e-mail: jdwebb@orthomedix.net | |
| Trade Name | Trabis® |
| Common Name | Vertebral body replacement device |
| Classification Name | Spinal intervertebral body fixation orthosis |
| Class | II |
| Product Code | PLR |
| CFR Section | 21 CFR section 888.3060 |
| Device Panel | Orthopedic |
| Primary Predicate | |
| Device | Cardinal Spine C-VBR (K152568) |
| Additional Predicate | |
| Devices | ostaPek® VBR System (K072326) |
| Reference Predicate | |
| Devices | ACIF (K173148) |
| Device Description | The devices included in this submission are a subset of the devices that were included in |
| the OstaPek® VBR System, cleared in K072326. The only difference between the Trabis® | |
| and the K072326 subset is that the Trabis® VBR are intended for the use in the cervical | |
| spine, whereas the devices cleared in K072326 were cleared for use in the thoracolumbar | |
| spine. Therefore, the purpose of this 510(k) is to modify the Indications for Use for the | |
| subject Trabis®. | |
| Materials | Polyether-ketone-ether-ketone-ketone (ASTM F1876-98) |
| Fiber carbon filaments | |
| Gold (ASTM B562-95) | |
| Intended Use | Trabis® provides structural support to the cervical spine by replacing cervical vertebral |
| bodies that have been removed as a result of disease or trauma. | |
| Substantial | |
| Equivalence Claimed | |
| to Predicate Devices | The Trabis® is substantially equivalent to the predicate devices in terms of intended use, |
| design, materials used, mechanical safety and performances. | |
| Indications for Use | Trabis® is a vertebral body replacement system indicated for use in the cervical spine |
| (from C2 to T1 vertebral bodies) in skeletally mature patients to replace a diseased or | |
| damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction | |
| following corpectomy performed to achieve decompression of the spinal cord and neural | |
| tissues in cervical degenerative disorders. Trabis® is intended to be used with | |
| supplemental fixation cleared by the FDA for use in the cervical spine. | |
| These implants are intended for use with autograft or allogenic bone graft comprising | |
| cancellous and/or corticocancellous bone graft, as an adjunct to fusion. Trabis® is also | |
| intended to restore the integrity of the spinal column even in the absence of fusion for a | |
| limited time period in patients with advanced stage tumors involving the cervical spine in | |
| whom life expectancy is of insufficient duration to permit achievement of fusion, with bone | |
| graft used at the surgeon's discretion. | |
| Summary of the | |
| technological | |
| characteristics | |
| compared to | |
| predicate | Intended Use |
| Trabis® and all the predicates have similar intended uses. | |
| Materials | |
| Trabis® is composed of the same material as the predicate device. | |
| Design Features/Functions | |
| Trabis® and cited predicate devices share similar basic design features and functions. | |
| Dimensions | |
| The subject Trabis® system is dimensionally similar to cited predicate devices. | |
| Sterilization | |
| Trabis® is provided non-sterile and cited predicate devices are sterile and non-sterile for | |
| single use only. | |
| Performance Specification | |
| Mechanical testing confirmed Trabis® demonstrated equivalent performance to the cited | |
| predicate device under the same test conditions. | |
| Non-clinical Test | |
| Summary | The following analyses were conducted: |
| • Static and dynamic compression per ASTM F2077 | |
| • Static and dynamic torsion per ASTM F2077 | |
| • Subsidence per ASTM F2267 | |
| The results of these evaluations indicate that Trabis® is equivalent to predicate devices. | |
| Clinical Test | |
| Summary | A study was presented analyzing the outcome and radiological findings for anterior cervical |
| corpectomy with the use of carbon composite Trabis®, as a support with space for grafts | |
| after cervical corpectomy of one or more levels, performed at three centers. | |
| All cervical corpectomy cases performed between June 2000 and May 2006 were | |
| retrospectively reviewed. Ninety-three patients were treated with the Trabis® after cervical | |
| corpectomy of one or more levels for different reasons. | |
| Conclusions: Non- | |
| clinical and Clinical | coLigne considers Trabis® to be substantially equivalent to the predicate devices listed |
| above. This conclusion is based upon the devices' similarities in principles of operation, | |
| technology, materials, performance data, and indications for use. |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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