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.

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®.

AI/ML Overview

The document provided is a 510(k) summary for the Trabis® vertebral body replacement system. It primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical (mechanical) testing and a retrospective clinical study.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

Acceptance Criteria and Reported Device Performance

For medical devices, "acceptance criteria" are generally established to demonstrate that the device performs as intended and is safe and effective. In a 510(k) submission, this often means demonstrating substantial equivalence to a legally marketed predicate device. The primary acceptance criteria for the Trabis® device, as inferred from the "Non-clinical Test Summary" and "Conclusions: Non-clinical and Clinical" sections, are related to its mechanical performance and clinical outcomes being comparable to predicate devices.

Acceptance Criterion (Inferred)	Reported Device Performance (from "Non-clinical Test Summary")
Mechanical Equivalence	"Mechanical testing confirmed Trabis® demonstrated equivalent performance to the cited predicate device under the same test conditions." Specific tests included:Static and dynamic compression per ASTM F2077Static and dynamic torsion per ASTM F2077Subsidence per ASTM F2267"The results of these evaluations indicate that Trabis® is equivalent to predicate devices."
Clinical Outcomes	"The study 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. . . . The submitted data indicates that Trabis® is substantially equivalent to the predicate devices with regard to its clinical performance." (This is indirectly inferred, as the document states overall substantial equivalence based on both non-clinical and clinical data, but doesn't explicitly state quantitative clinical acceptance criteria).

Acceptance Criterion (Inferred)

Reported Device Performance (from "Non-clinical Test Summary")

Mechanical Equivalence

"Mechanical testing confirmed Trabis® demonstrated equivalent performance to the cited predicate device under the same test conditions." Specific tests included:Static and dynamic compression per ASTM F2077Static and dynamic torsion per ASTM F2077Subsidence per ASTM F2267"The results of these evaluations indicate that Trabis® is equivalent to predicate devices."

Clinical Outcomes

"The study 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. . . . The submitted data indicates that Trabis® is substantially equivalent to the predicate devices with regard to its clinical performance." (This is indirectly inferred, as the document states overall substantial equivalence based on both non-clinical and clinical data, but doesn't explicitly state quantitative clinical acceptance criteria).

Study Details:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: "Ninety-three patients were treated with the Trabis® after cervical corpectomy of one or more levels for different reasons." So, N=93 patients.
- Data Provenance: The study was "retrospectively reviewed." It was conducted at "three centers." The country of origin is not explicitly stated in the provided text.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts used to establish the ground truth or their qualifications. It mentions "analyzing the outcome and radiological findings," which implies some form of assessment, but not who performed it or how consensus was reached.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not provide any information on the adjudication method used for the test set.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical vertebral body replacement system, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not an algorithm, so a standalone algorithm performance study is not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth appears to be based on "outcome and radiological findings" from the retrospective review of patient cases. This implies a combination of clinical assessments and imaging interpretations. The specific details of how these "findings" were adjudicated or confirmed (e.g., against pathology, long-term outcomes) are not detailed.
The sample size for the training set:
- The document describes a retrospective clinical study for performance evaluation, not an AI/algorithm-based device that would typically have a separate "training set." Therefore, no training set sample size is mentioned.
How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set for an algorithm.

Summary

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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)

K173893

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 LangecoLigne, AGUtoquai 43CH 8008 ZurichSwitzerlandTelephone: +41 43 343 8000e-mail: robert.lange@coligne.com
Primary Contact	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Telee-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 PredicateDevice	Cardinal Spine C-VBR (K152568)
Additional PredicateDevices	ostaPek® VBR System (K072326)
Reference PredicateDevices	ACIF (K173148)
Device Description	The devices included in this submission are a subset of the devices that were included inthe 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 cervicalspine, whereas the devices cleared in K072326 were cleared for use in the thoracolumbarspine. Therefore, the purpose of this 510(k) is to modify the Indications for Use for thesubject Trabis®.
Materials	Polyether-ketone-ether-ketone-ketone (ASTM F1876-98)Fiber carbon filamentsGold (ASTM B562-95)
Intended Use	Trabis® provides structural support to the cervical spine by replacing cervical vertebralbodies that have been removed as a result of disease or trauma.
SubstantialEquivalence Claimedto 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 ordamaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstructionfollowing corpectomy performed to achieve decompression of the spinal cord and neuraltissues in cervical degenerative disorders. Trabis® is intended to be used withsupplemental fixation cleared by the FDA for use in the cervical spine.These implants are intended for use with autograft or allogenic bone graft comprisingcancellous and/or corticocancellous bone graft, as an adjunct to fusion. Trabis® is alsointended to restore the integrity of the spinal column even in the absence of fusion for alimited time period in patients with advanced stage tumors involving the cervical spine inwhom life expectancy is of insufficient duration to permit achievement of fusion, with bonegraft used at the surgeon's discretion.
Summary of thetechnologicalcharacteristicscompared topredicate	Intended UseTrabis® and all the predicates have similar intended uses.MaterialsTrabis® is composed of the same material as the predicate device.Design Features/FunctionsTrabis® and cited predicate devices share similar basic design features and functions.DimensionsThe subject Trabis® system is dimensionally similar to cited predicate devices.SterilizationTrabis® is provided non-sterile and cited predicate devices are sterile and non-sterile forsingle use only.Performance SpecificationMechanical testing confirmed Trabis® demonstrated equivalent performance to the citedpredicate device under the same test conditions.
Non-clinical TestSummary	The following analyses were conducted:• Static and dynamic compression per ASTM F2077• Static and dynamic torsion per ASTM F2077• Subsidence per ASTM F2267The results of these evaluations indicate that Trabis® is equivalent to predicate devices.
Clinical TestSummary	A study was presented analyzing the outcome and radiological findings for anterior cervicalcorpectomy with the use of carbon composite Trabis®, as a support with space for graftsafter cervical corpectomy of one or more levels, performed at three centers.All cervical corpectomy cases performed between June 2000 and May 2006 wereretrospectively reviewed. Ninety-three patients were treated with the Trabis® after cervicalcorpectomy of one or more levels for different reasons.
Conclusions: Non-clinical and Clinical	coLigne considers Trabis® to be substantially equivalent to the predicate devices listedabove. 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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Regulation Number and Section

§ 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.